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Mydecine Innovations: Unlocking Fungi’s Pharmacological and Nutraceutical Healing Properties

Published at The Dales Report

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By Benjamin A. Smith

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Mydecine Innovations: Unlocking Fungi’s Pharmacological and Nutraceutical Healing Properties

In the world of early-stage psychedelic investing, leadership matters. With future revenue streams uncertain and developmental roadmaps being devised from scratch, innovation and management competency are high on the list of investor considerations. Enter Mydecine Innovations, whose A-to-Z psilocybin research model rivals or exceeds many larger market cap peers in the sector.

What Does Mydecine Do?

Above all else, Mydecine is an industry leader in the study of mycology, or the branch of biology concerned with the study of fungi—including its genetic and biochemical properties. Throughout history, mycology research has led to the development of important antibiotic drugs such as penicillin, streptomycin, and tetracycline, as well as cholesterol-lowering statin drugs. While it’s possible the company might back into a similar non-core discovery, the company is targeting different therapeutic areas altogether.

Mydecine is somewhat of a paradox in that it is both operationally diverse, yet has a very simple mission statement. Through its vertically-integrated operations, it aims to become a leader in the cultivation, processing, product development, and research and development of various strains of mushroom and fungi from all around the world; to unlock the full potential of fungi in both pharmacological and nutraceutical domains. Thus, Mydecine is in a unique position of being able to monetize an array of pharmaceutical and CPG pathways—specifically relating to mental health and wellness applications.

On the clinical side, Mydecine is best known for its upcoming international Phase 2A study that will focus on psilocybin-assisted psychotherapy to treat chronic PTSD in veterans and EMS personnel. The research will take place at various clinical sites across three continents in an effort to establish the safety and efficacy of psychedelic administered psychotherapy in a supervised setting.

Although Mydecine’s trial is objectively behind Compass Pathways’ Phase 2b psilocybin-assisted therapy study for treatment-resistant depression, it is perhaps the most comparable psilocybin assisted-therapy based study among Compass’ competitors trading on the public markets. The companies are targeting different indications, however, depression and its many subsets share intertwining affinities.

Mydecine is also sponsoring an important study to determine whether microdosing leads to changes in novelty perception or pattern recognition. The study titled: “Neurocognitive Effects of Low Dose Psychoactive Substances” will take place at Australia’s Macquarie University and will helping to build a database library to help the company understand microdosing works. Such understanding will help build a foundation for future intellectual property development and clinical trial design.

Scientific Advisory Board member Dr. David Erritzoe has previously helped execute a large-scale microdosing study co-sponsored by the National Institute for Health Research at Imperial College of London.

Mydecine Research & Development/IP

Mydecine has the ability to oversee all areas of drug development—from the production of Psilocybe mushrooms to its synthesis to product commercialization and distribution. Central to this vertically-integrated strategy is the company’s seven patent pending applications representing multiple layers of protection on its drug development pipeline and technology assets.

By developing a greater understanding of the therapeutic properties of fungi-based compounds, Mydecine is creating novel intellectual property around specialized mental wellness solutions. Spearheaded by Chief Scientific Officer Rob Roscow, its patent portfolio is designed to unlock innovative medication design and distribution pathways, accurate dosable formulations and emerging developments for increased use of psilocybin in a medical setting.

Central to this strategy is Mydecine’s industry-leading psychedelics telemedicine platform, which is an instrumental part of its assisted-therapy support system.

The company recently announced that it has filed a provisional patent for its Mindleap Health technology platform in both The United States Patent and Trademark Office (USPTO) and the Canadian Intellectual Property Office. The app combines mood, emotion and habit tracking allowing users to purchase and receive virtual mental health coaching from an international network of specialists.

Can Psychedelic-Focused Telemedicine Apps Take A Bite From The Apple?

With the global telemedicine market worth an estimated USD 41.4 billion (2019) and expected to grow at a CAGR of 15.1% until 2027, Mydecine is seeking to protect this first-mover application. With web/mobile based delivery model expected to witness significant growth in the coming years, the Mindleap app offers direct access-to-care delivery solutions. It’s perhaps an underappreciated asset which should provide supplementary value along Mydecine’s assisted-therapy delivery chain.

On the research & development side, Mydecine also operates out of a state-of-the-art mycology lab in Denver, CO to focus on genetic research for scaling commercial cultivation of rare (non-psychedelic) medicinal mushrooms. The Mydecine Center of Mycology (MYCOM) features a 7500 sq. ft mycology lab, full-scale commercial fungi cultivation capabilities, mass spectrometer equipment… the works. It is here that Mydecine will attempt to unlock the science behind the mushroom, and parlay its research into new intellectual property, psilocybin and nutraceutical formulations. Longer term, the company has devised a planned expansion to research psilocybin under DEA licensure as regulations allow.

In Canada, Mydecine has established an R&D partnership with Applied Pharmaceutical Innovation (API) through the Alberta Faculty Of Pharmacy And Pharmaceutical Sciences out of the University of Alberta. The relationship provides Mydecine with many tangible benefits, including:

  • Access to a full cGMP certified pharmaceutical manufacturing facility
  • Ability to import/export, extract, and analyze psychedelic medicine with full government approval through Health Canada Schedule 1 Substances and Drugs Dealer’s License
  • Access to a wide range of world-class scientific researchers
  • Artificial intelligence capabilities to identify biosynthesis pathways for medicine discovery, optimize targeted medicine delivery systems and to design marketable medicinal compounds

Whether through organic developmental research or through collaborations at major universities, Mydecine is committed like no other when it comes to understanding fungi in pharmacological and nutraceutical contexts. The bet for investors is that its heavy R&D emphasis will eventually translate into mental wellness therapies and applications that can be monetized in many diverse ways.

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Mydecine Fully Completes the First-Ever International Export of Psilocybin Mushrooms and Solidifies its Clinical and Commercial Supply Chain

Published at GlobeNewsWire.com

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DENVER, March 01, 2021 (GLOBE NEWSWIRE) — Mydecine Innovations Group (CSE: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company’), an emerging biopharma company in the life sciences category committed to the research and development, production, and acceptance of alternative nature-sourced medicine for mainstream use, has completed the world’s first international legal export of dried psilocybin mushrooms.

In December 2020, the Company announced the completion of its first commercial harvest of 20 kilograms (44 lbs) of psilocybin mushrooms at a private mycology-focused research and cultivation facility in Jamaica. The first shipment of the harvest has now been received at Mydecine’s Canadian Current Good Manufacturing Practice (CGMP) facility, which has a Health Canada Schedule 1 Dealer’s License attached to it, allowing for legal import/export, research and development, cultivation, product development, and commercial sale of active psychedelic medicinal compounds.

“This milestone is significant to our 2021 goals as we are now able to access a quality source of much needed product for both our own research purposes, as well as provide CGMP naturally-derived psilocybin to sell and transfer to other licensed research facilities around the globe. Our team has spent significant time working with various government agencies to create and develop sound protocols to ensure a smooth flow of biomass that is in full compliance with all federal laws. This is the first and only solidified commercial supply chain of psilocybin mushrooms and we believe this supply chain will open up many doors to potentially collaborate and participate in initiatives that we find potentially promising,” said Joshua Bartch, CEO and Chairman of Mydecine. “We have made significant progress towards having the first IND number on a 99.9% pure psilocybin product that the synthetic form mimics. We believe our natural-sourced psilocybin, that is both significantly less costly and more efficient than the synthetic form, will prove to be a better overall option to meet the current market demand as well as voids any and all potential patent claims. This marks a milestone of fulfilling on the promise of creating a fully vertical and uninterrupted global supply chain.”

“In the most potent psychedelic mushrooms, psilocybin is typically only around 1% of its total mass. This means that as much as 99% of the mushroom is composed of vegetative matter plus other potential active medicinal compounds. At our lab, we have already discovered multiple other active compounds separate from psilocybin and psilocin from just our initial psychedelic mushroom analysis. Based upon our preliminary studies, we believe that this could have more effective results than just single-molecule synthetic psilocybin. This supply chain will give us unrestrictive scalable access including numerous types of unique psychedelic mushroom species native to Jamaica. This should significantly increase our research and development and production efforts with some of the best types of mushrooms that we know of,” said Damon Michaels, Mydecine’s Co-Founder and Chief Operating Officer.

He continued, “Throughout history we have seen many historical instances involving the use of psychedelic medicine, more so the use of psychedelic mushrooms to be used as safe and effective therapeutic medicine to help improve mental injuries or expand one’s overall consciousness. Today we are able to take this ancient form of holistic medicine and pair it with modern technology to better understand its active ingredients and how they specifically interact with the brain and body to produce the best, most controllable and beneficial results possible. For Mydecine to be able to create the world’s first legal global supply chain of nature-sourced psilocybin to not only meet its own needs, but to supply to other licensed research organizations, universities, and healthcare facilities around the world, we hope to finally break the barrier of stigma and help people obtain mainstream access to this sacred medicine and turn it back into a traditional therapy.”

About Mydecine Innovations Group
Mydecine Innovations Group™ (CSE: MYCO) (OTC:MYCOF) (FSE:0NFA) is an emerging biotech and life sciences company dedicated to developing and commercializing innovative solutions for treating mental health problems and enhancing vitality. The company’s world-renowned medical and scientific advisory board is building out a robust R&D pipeline of nature-sourced psychedelic-assisted therapeutics, novel compounds, therapy protocols, and unique delivery systems. Mydecine has exclusive access to a full cGMP certified pharmaceutical manufacturing facility with the ability to import/export, cultivate, extract/isolate, and analyze active mushroom compounds with full government approval through Health Canada. Mydecine also operates out of a state-of-the-art mycology lab in Denver, CO to focus on genetic research for scaling commercial cultivation of rare (non-psychedelic) medicinal mushrooms.

At the heart of Mydecine’s core philosophy is that psychedelic-assisted psychotherapy will continue to gain acceptance in the medical community with many of the world’s best accredited research organizations demonstrating its remarkable clinical effectiveness. Mydecine recognizes the responsibility associated with psychedelic-assisted therapy and will continue to position itself as a long-term leader across the spectrum of clinical trials, research, technology, and global supply. Mydecine has also successfully completed multiple acquisitions since its inception.

Learn more at: https://www.mydecine.com/ and follow us on Facebook, Twitter, and Instagram.

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For further information about Mydecine Innovations Group, Inc., please visit the Company’s profile on SEDAR at www.sedar.com or visit the Company’s website at www.mydecine.com.

The Canadian Securities Exchange has neither approved nor disapproved the contents of this news release and accepts no responsibility for the adequacy or accuracy hereof. This news release contains forward-looking information within the meaning of Canadian securities laws regarding the Company and its business, which relate to future events or future performance and reflect management’s current expectations and assumptions. Often but not always, forward-looking information can be identified by the use of words such as “expect”, “intends”, “anticipated”, “believes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would” or “will” be taken, occur or be achieved. Such forward-looking statements reflect management’s current beliefs and are based on assumptions made by and information currently available to the Company. Readers are cautioned that these forward-looking statements are neither promises nor guarantees, and are subject to risks and uncertainties that may cause future results to differ materially from those expected including, without limitation, risks regarding the COVID-19 pandemic, the availability and continuity of financing, the ability of the Company to adequately protect and enforce its intellectual property, the Company’s ability to bring its products to commercial production, continued growth of the global adaptive pathway medicine, natural health products and digital health industries, and the risks presented by the highly regulated and competitive market concerning the development, production, sale and use of the Company’s products. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information. These forward-looking statements are made as of the date hereof and the Company does not assume any obligation to update or revise them to reflect new events or circumstances save as required under applicable securities legislation.

This news release does not constitute an offer to sell securities and the Company is not soliciting an offer to buy securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. This news release does not constitute an offer of securities for sale in the United States. These securities have not and will not be registered under United States Securities Act of 1933, as amended, or any state securities laws and may not be offered or sold in the United States or to a U.S. Person unless so registered, or an exemption from registration is relied upon.

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Mydecine Announces Exclusive Partnership and Increased Capabilities with Applied Pharmaceutical Innovation (API) at the University of Alberta

February 24, 2021

Published at GlobeNewsWire.com

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DENVER, Feb. 24, 2021 (GLOBE NEWSWIRE) — Mydecine Innovations Group (CSE: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company’), an emerging biopharma and life sciences company committed to the research, development, and acceptance of alternative nature-sourced medicine for mainstream use, has announced an exclusive partnership with Applied Pharmaceutical Innovation (API) at the University of Alberta, as well as expanded capabilities that enables support of multiple drug development and clinical trial programs simultaneously.

“With our expanded relationship with API, we can now synthesise multiple molecules concurrently as well as run research and development and pre-clinicals on site,” said Rob Roscow, Chief Scientific Officer and Co-founder of Mydecine. “We now have the ability to accelerate both natural product research and novel drug design, specifically in the field of serotonin psychedelics. This will serve to boost our patent portfolio and increase our speed to bring these drugs to market.”

The partnership significantly expands research capacity and accelerates both drug development from natural products as well as “novel” drug development. Through this partnership the company currently has the ability to legally cultivate, extract, import, export and commercialize full cGMP pharmaceutical grade natural and synthetic compounds to reciprocal licensed facilities globally. The company expects the increased capabilities to further expand the cGMP offerings.

“Through their work with us, Mydecine has access to tens of millions of dollars of research infrastructure at our facilities across Alberta, and the capability to conduct an extremely robust drug development program,” said Andrew MacIsaac, CEO of Applied Pharmaceutical Innovation. “One of the largest barriers for earlier stage companies as they grow is building true commercial R&D capacity, particularly in a quickly moving sector,” said MacIsaac, “under their agreement with API Mydecine has this in droves and the ability to scale their many programs, pursuing research and development at the cutting edge of this rapidly emerging field.”

Debt Settlement Update

Separately, Mydecine also announces that its board of directors has approved the settlement of a principal amount of CAD$43,083.70 in debt for services rendered through the issuance of common shares (the “Debt Settlement”). Pursuant to the Debt Settlement, the Company issued 92,654 common shares of the Company (the “the Shares”) at a deemed price of $0.465 per Share to a creditor of the Company. All securities issued in connection with the Debt Settlement will be subject to a statutory hold period which will expire on the date that is four months and one day from the date of issuance.

About Mydecine Innovations Group

Mydecine Innovations Group™ (CSE: MYCO) (OTC:MYCOF) (FSE:0NFA) is an emerging biotech and life sciences company dedicated to developing and commercializing innovative solutions for treating mental health problems and enhancing vitality. The company’s world-renowned medical and scientific advisory board is building out a robust R&D pipeline of nature-sourced psychedelic-assisted therapeutics, novel compounds, therapy protocols, and unique delivery systems. Mydecine has exclusive access to a full cGMP certified pharmaceutical manufacturing facility with the ability to import/export, cultivate, extract/isolate, and analyze active mushroom compounds with full government approval through Health Canada. Mydecine also operates out of a state-of-the-art mycology lab in Denver, CO to focus on genetic research for scaling commercial cultivation of rare (non-psychedelic) medicinal mushrooms.

At the heart of Mydecine’s core philosophy is that psychedelic-assisted psychotherapy will continue to gain acceptance in the medical community with many of the world’s best accredited research organizations demonstrating its remarkable clinical effectiveness. Mydecine recognizes the responsibility associated with psychedelic-assisted therapy and will continue to position itself as a long-term leader across the spectrum of clinical trials, research, technology, and global supply. Mydecine has also successfully completed multiple acquisitions since its inception.

Learn more at: https://www.mydecine.com/ and follow us on Facebook, Twitter, and Instagram.

‍For further information about Mydecine Innovations Group, Inc., please visit the Company’s profile on SEDAR at www.sedar.com or visit the Company’s website at www.mydecine.com.

The Canadian Securities Exchange has neither approved nor disapproved the contents of this news release and accepts no responsibility for the adequacy or accuracy hereof. This news release contains forward-looking information within the meaning of Canadian securities laws regarding the Company and its business, which relate to future events or future performance and reflect management’s current expectations and assumptions. Often but not always, forward-looking information can be identified by the use of words such as “expect”, “intends”, “anticipated”, “believes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would” or “will” be taken, occur or be achieved. Such forward-looking statements reflect management’s current beliefs and are based on assumptions made by and information currently available to the Company. Readers are cautioned that these forward-looking statements are neither promises nor guarantees, and are subject to risks and uncertainties that may cause future results to differ materially from those expected including, without limitation, risks regarding the COVID-19 pandemic, the availability and continuity of financing, the ability of the Company to adequately protect and enforce its intellectual property, the Company’s ability to bring its products to commercial production, continued growth of the global adaptive pathway medicine, natural health products and digital health industries, and the risks presented by the highly regulated and competitive market concerning the development, production, sale and use of the Company’s products. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information. These forward-looking statements are made as of the date hereof and the Company does not assume any obligation to update or revise them to reflect new events or circumstances save as required under applicable securities legislation.

This news release does not constitute an offer to sell securities and the Company is not soliciting an offer to buy securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. This news release does not constitute an offer of securities for sale in the United States. These securities have not and will not be registered under United States Securities Act of 1933, as amended, or any state securities laws and may not be offered or sold in the United States or to a U.S. Person unless so registered, or an exemption from registration is relied upon.

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Behind the World-First Export of Jamaican Psilocybin Mushrooms

February 19, 2021

Published at TechnologyNetworks.com

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By Laura Elizabeth Lansdowne, Managing Editor, and Ruairi J MacKenzie, Sr. Science Writer

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Behind the World-First Export of Jamaican Psilocybin Mushrooms

To better understand the therapeutic potential of naturally-occuring psilocybin, biotech and life sciences company Mydecine Innovations Group is taking steps to produce larger quantities of these molecules for research purposes. As part of this effort, Mydecine recently announced that it had completed the first harvest and commercial export of legal psychedelic psilocybin mushrooms from Jamaica to Canada. We spoke with Mydecine’s chief scientific officer and co-founder, Rob Roscow, to find out more.

Ruairi Mackenzie (RM): What are the regulations surrounding the growth of psilocybin-containing mushrooms? Has the export of this harvest been a straightforward process?

Rob Roscow (RR): Outside of Jamaica, psilocybin-containing mushrooms are a controlled substance and all of our research is compliant with this through the clinical trial structures that we use. Jamaica is unique in allowing the cultivation of psilocybin-producing mushrooms in the same way as other gourmet mushrooms. Through our licensure across multiple jurisdictions, we have not had any issues with import/export.

RM: What are the next steps for the harvest? How will it be turned into therapeutic-grade product?

RR: The harvest will be transferred to the University of Alberta, Advanced Pharmaceutical Innovation and their pharmaceutical labs. This is where our entire therapeutic-grade product is produced for clinical trials.

RM: For perspective, how significant is the import of 20 kg of psilocybin mushrooms? For instance, how many therapeutic doses can be derived from that amount?

RR: For comparison purposes, this represents over 4000 clinical study doses, while also supporting our border research purposes in general.

RM: Is there future scope for domestic psilocybin cultivation and harvesting?

RR: This is an open-ended question as the industry matures. When psilocybin and similar compounds receive regulatory approval post clinical trials; production will naturally need to scale up. This is a few steps away.

Laura Lansdowne (LL): What are the benefits to cultivating natural psilocybin mushrooms, rather than utilizing other bio-based or synthetic psilocybin production methods?

RR: There is a long history of human use of psilocybin-producing mushrooms in their natural state. Additionally, nature is very efficient at producing psilocybin and this can be leveraged for efficient production. Mydecine believes that natural production is sustainable and scalable into the future.

LL: You mention that portions of the natural psilocybin mushroom harvest will also be used for Mydecine’s genetic, pharmacology and clinical research, are you able to elaborate on some of the company’s planned R&D activities?

RR: The company is very interested in the promise and chemical diversity produced in psilocybin mushrooms and the potential it has in medical applications. We always let the research and data steer our drug development course and are actively looking at improvements in production, pharmacology and clinical use. The research around the medical use of these compounds is in a nascent state and we will see significant improvement in all areas in the coming years. This is a complex but valuable topic and the company is positioned research wise to address this potential in a step-by-step fashion.

‍LL: Mydecine recently announced that it had sponsored a study on the neuron-level response to psilocybin, could you tell us more about this research?

RR: Mydecine is excited to support the work of Dr Jaylyn Waddell, at the University of Maryland. The study has great potential to demonstrate neuron-level response to psilocybin treatment and provide direct links to behavior-level effects. Understanding psilocybin’s function from the neuron up will enable better development of human touching therapies.

Rob Roscow was speaking to Laura Elizabeth Lansdowne, Managing Editor, and Ruairi Mackenzie, Senior Science Writer for Technology Networks.

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Truffle Talk with Joshua Bartch of Mydecine Innovations Group

Published at Truffle Report

By Emily Jarvie

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Josh Bartch Mydecine

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  • Mydecine Innovations Group co-founder and CEO Joshua Bartch speaks to Truffle Report about the company’s psychedelics research program.
  • Mydecine’s lead program is focused on psilocybin and the treatment of post-traumatic stress disorder (PTSD).
  • Bartch says the company will be listed on three senior stock exchanges over the coming months.

At a time when he was looking for the next big industry, entrepreneur Joshua Bartch was attracted to the world of fungi by its unique compounds. “Diversification is incredibly important. With fungi, you can pursue oil remediation, break down plastic, and solve a lot of the world’s problems,” Bartch tells Truffle Report.

Along with geneticist Robert Roscow and hemp consultant Damon Michaels, Bartch co-founded biotechnology and life sciences company Mydecine Innovations Group to develop psychedelic-assisted therapies. “Our focus is the unique compounds that can promote health and wellness, and psychedelic compounds that can address unmet needs in the mental health arena,” Bartch says of the Colorado-based company.

Prior to becoming the CEO of Mydecine, Bartch had worked in the cannabis industry in Denver, Colorado starting in 2009. When recreational cannabis was legalized in the state in 2014, he launched Cannabase, a technology platform that connected standalone cultivators and retailers which was acquired 16 months later by Helix GCS. After selling significant professional and private cannabis-related assets, Bartch moved into mergers and acquisitions (M&A) and investing which ultimately led him to the psychedelics space.

Mydecine Conducting Clinical Trials on Psilocybin and PTSD

Bartch tells Truffle Report that Mydecine’s lead program is focused on the use of psilocybin and psilocybin-like compounds in conjunction with strict psychotherapy protocols for the treatment of post-traumatic stress disorder (PTSD), particularly among veteran populations. “In the United States alone, a veteran commits suicide every 72 minutes. That’s over 22 a day,” Bartch says.

“For whatever reasons, there’s been complacency with the current treatment models that maybe work half the time for half the population. Currently, there is not a single pharmaceutical drug that is manufactured for PTSD. Everything is borrowed, off-label, such as selective serotonin reuptake inhibitors (SSRIs) and Prozac which are incredibly dangerous drugs and are really ineffective for the treatment of PTSD because they carry side effects like suicide.”

Bartch says Mydecine has been working off a body of evidence from the 1950s and 60s which showed one to three macrodoses of psilocybin treatments, accompanied by strict psychotherapy protocols, had a success rate in excess of 75 percent in eliminating PTSD. “What is exciting for us is we are dealing with very ineffective band-aids that carry incredible negative side effects and we are able to replace it was a non-addictive, non-invasive treatment that has no known long-term side effects and can essentially act as a cure with one to three treatments combined with psychotherapy protocols,” he says.

Mydecine is ready to conduct Phase 2A clinical trials revolving around the use of psilocybin to treat PTSD, however, the trials have been put on hold due to COVID-19. “We have approved test sites at Leiden University in the Netherlands, the University of Western Ontario and the University of Alberta in Canada, and we are about to announce three very prominent veterans-focused sites in the United States,” Bartch says. He adds that the trial is expected to begin in the next few months once restrictions around COVID-19 allow it to proceed. “We don’t want to start the trial and then have to stop. To stop and restart could be very expensive and from a pure data standpoint is not the best,” he says.

Exclusive Partnership Sets Mydeceine Apart

Bartch says Mydecine’s exclusive access to a full cGMP pharmaceutical manufacturing facility at the University of Alberta was one way the company differentiated itself from others in the psychedelics space. “We have the ability to go from A to Z and turn a concept into reality,” Bartch tells Truffle Report. “Through the University of Alberta, which is covered by a Health Canada dealer’s licence, we have the ability to cultivate, extract, and isolate compounds which we can sell commercially. We can provide that active pharmaceutical ingredient (API) for our clinical trials to drastically lower the cost of our API or leverage our ability to produce these compounds, which can be used on humans, to participate in other studies we think are interesting or hold potential. To leverage that in exchange for shared data is advantageous.”

He adds that Mydecine supports the work of organizations exploring the medical potential of psychedelics in a responsible manner, such as through the passage of Measure 109 in Oregon. While Mydecine cannot take part in this state-based program itself, Bartch says the company supported the cause because it believes public acceptance of psychedelics is a significant barrier. “We don’t support the recreational use of psychedelics in any instance at all because we think it is a completely different substance to THC and it holds a higher medical potential to change the way mental health is being treated. Anything that is done responsibly that will better educate the public we think is a great thing for the industry,” he says.

Listing of Mydecine on Three Senior Stock Exchanges Underway

Mydecine is currently in the process of being listed on three senior stock exchanges: the NEO exchange in Canada, the London Securities Exchange (LSE) in the United Kingdom, and NASDAQ in the United States. The company is currently listed on the Canadian Securities Exchange (CSE) under the ticker symbol MYCO, on OTC Markets (OTC) in the United States under MYCOF, and on the Frankfurt Securities Exchange (FSE) under 0NFA.

Bartch tells Truffle Report he expects the first of the three new listings to be finalized will be the NEO exchange listing. “We believe that we will be trading on the NEO exchange within the next 30 days, around the first or second week of March,” he says. For the LSE, Bartch says Mydecine’s preliminary prospectus will be completed within the next few weeks. For the NASDAQ, Mydecine has been appointed a reviewer and Bartch says he expects the company will be listed in the next four to six months. “We continue to check boxes off,” Bartch says. “We have a couple of initiatives in the company that I can’t talk about now but the market should react accordingly and that should get us over the price requirement if not there could be additional capital raising to meet that requirement,” he says.

Being included in Horizons ETFs Managements’ first psychedelic stock ETF which began trading on the NEO Exchange in January is an honour, Bartch says. “The ETF was incredibly beneficial for the industry as a whole,” he says. “We would have been incredibly disappointed if we weren’t included because we feel we are an industry leader. As some of the initiatives we are working on come to light, we expect our percentage in the ETF will increase as we grow as a company.”

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Mydecine Innovations Group Announces Filing of a Provisional Patent for Mindleap’s Mental Health Technolog

Published at globenewswire.com

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DENVER, Feb. 17, 2021 (GLOBE NEWSWIRE) — Mydecine Innovations Group, Inc., (CSE:MYCO) (OTC:MYCOF) (FSE:0NFA) (“Mydecine” or the “Company”) is pleased to announce that its subsidiary Mindleap Health (“Mindleap”), a digital health platform and the world’s-first telemedicine application purpose-built for the psychedelic medicine industry, has filed a provisional patent for its technology platform in both The United States Patent and Trademark Office (USPTO) and the Canadian Intellectual Property Office.

“As our company continues to innovate we are focused on vigorous protection of all of our inventions,” said Mydecine CEO and Chairman Josh Bartch. “Mindleap’s software patents will strengthen our intellectual property portfolio overall which now totals 8 patent filings currently in process.”

Mindleap’s telemedicine platform combines mood, emotion and habit tracking that allows users to purchase and receive virtual mental health coaching from an international network of specialists. In the coming months, Mindleap’s software development team will introduce more advanced mental health and wellbeing tools including expert on-demand programs, streaming mental wellbeing content and convenient and affordable access to mental health support right from the palm of their hand. These inventions cover various advanced technologies currently in development with the most vital being digital mental health and wellbeing programs, enhanced data collection and aggregation, proprietary wellbeing score and personalized automated alerts and suggestions.

Mindleap 2.0

Since the launch of the initial app in Fall 2020, Mydecine has developed Mindleap 2.0, a refined version of the platform that enhances the end-user experience in order to deliver improved patient outcomes. Enhancements to the platform include improved remote telemedicine services and a newly reskinned user interface expected to launch in Spring 2021.

“We’re really excited about what we’re working on right now at Mindleap. There are a number of advancements that we’ll be introducing to the public over the next few months, and we can’t wait to see how our users respond,” said Jack Bunce, Head of Digital at Mindleap. “More than ever before people are looking for ways to access high-quality, on-demand content that will positively impact their mental health and well-being. Through the creative partnerships we’ve formed and the digital programs we’ve developed, there is an outstanding opportunity to continue to leverage the telehealth experience into something that can help people make significant progress on their mental health journey.”

Included in the launch of Mindleap 2.0 is the release of new Digital Mental Health and Well-Being Programs. Each of these new programs will feature daily audio and or video sessions created by world-class experts in each of their respective fields. The updated platform will also include various audio programs ranging from psychedelic integration, addiction, meditation, breathwork, cognitive behavioral therapy and others. As development progresses further, Mindleap technologies will include advancements that will take advantage of enhanced data collection and analytics to bring forth further assistance to users including a proprietary Mindleap Well-Being Score.

About Mindleap Health

Mindleap Health Inc. is a virtual healthcare company that offers technology solutions that allow people to improve their mental health and wellbeing. The Mindleap platform provides remote telemedicine services for mental health coaching through its international network of mental health specialists along with mental health tracking and analytics. The Mindleap platform brings convenience, improves access to treatments and can lead to more personal breakthroughs. Mindleap’s proprietary platform is designed to provide professional support and personalized treatment for every user. The company’s mission is to upgrade mental health by simplifying, modernizing, and improving access to mental health treatments for millions of people around the world.

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Watch the Mindleap Platform Overview Video

Apply to become a Specialist on Mindleap

Learn about Mindleap Health

Learn about The Past and Future of Psychedelics as a Medicine

For further information about Mydecine Innovations Group Inc., please visit the Company’s profile on SEDAR at www.sedar.com or visit the Company’s website at www.mydecine.com.

‍Mindleap Health Platform Services Disclaimer: Mindleap Services are designed to connect users of our Services with mental health specialists so as to receive assistance and guidance with integrating their prior psychedelic or consciousness-expanding experiences and translating them into positive changes. Our Services are not designed or intended for the integration or translation of a presently occurring psychedelic experience and must not be used for that purpose. Psychedelic substances are legally controlled or prohibited in many jurisdictions, but there are legal means to have a psychedelic or conscious-expanding experience in certain circumstances. You are solely responsible and liable for adequately informing yourself of the Laws of your jurisdiction before using our Services and determining if use of our Services and the receipt of Specialist Services (defined below) is lawful in your jurisdiction. Our Services are meant to be used exclusively in connection with lawful activities and must not be used in connection with illegal substances or illegal activities. Without limiting the previous sentence, you are not permitted to promote, procure, consume, or sell illegal substances through the Services. Do not use psychedelic substances if doing so is unlawful in your jurisdiction. Possession of psychedelic substances in violation of applicable laws can carry significant penalties, including years of incarceration.

The Canadian Securities Exchange has neither approved nor disapproved the contents of this news release and accepts no responsibility for the adequacy or accuracy hereof. This news release contains forward-looking statements, which relate to future events or future performance and reflect management’s current expectations and assumptions. Such forward-looking statements reflect management’s current beliefs and are based on assumptions made by and information currently available to the Company. Readers are cautioned that these forward-looking statements are neither promises nor guarantees, and are subject to risks and uncertainties that may cause future results to differ materially from those expected including, without limitation, the availability and continuity of financing, the ability of the Company to adequately protect and enforce its intellectual property, the Company’s ability to bring its products to commercial production, continued growth of the global adaptive pathway medicine, natural health products and digital health industries, and the risks presented by the highly regulated and competitive market concerning the development, production, sale and use of the Company’s products. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information. These forward-looking statements are made as of the date hereof and the Company does not assume any obligation to update or revise them to reflect new events or circumstances save as required under applicable securities legislation. This news release does not constitute an offer to sell securities and the Company is not soliciting an offer to buy securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. This news release does not constitute an offer of securities for sale in the United States. These securities have not and will not be registered under United States Securities Act of 1933, as amended, or any state securities laws and may not be offered or sold in the United States or to a U.S. Person unless so registered, or an exemption from registration is relied upon.

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Magic mushroom therapy could help treat PTSD in Canadian military vets

Published at TheGrowthOp.com

‍This story first appeared in Weekend Dispensary, a new weekly newsletter from The GrowthOp.

By Sam Riches

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According to Veterans Affairs Canada, it is estimated that up to 10 per cent of war zone veterans — including war-service veterans and peacekeeping forces — will experience PTSD. PHOTO BY WIKIMEDIA COMMONS

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Having spent more than 30 years as a medical officer and psychiatrist in the Canadian Armed Forces, including deployments in Rwanda and Afghanistan, Dr. Rakesh Jetly has both a personal and professional interest in post-traumatic stress disorder (PTSD)

A chronic condition, PTSD is defined by the Canadian Mental Health Association as a mental illness that “involves exposure to trauma involving death or the threat of death, serious injury, or sexual violence.”

According to Veterans Affairs Canada, it is estimated that up to 10 per cent of war zone veterans — including war-service veterans and peacekeeping forces — will experience PTSD. There is not a clear explanation as to why some people are more affected than others.

The condition can be particularly hard to treat in veterans, Dr. Jetly says.

“There are lots of evidence-based treatments for post-traumatic stress disorder but like many treatments in mental health, they don’t work for everybody,” he says. “So there’s a huge need to think outside the box and think about novel ways in which to help people that are suffering with post-traumatic stress disorder.”

In November 2020, Dr. Jetly was named the Chief Medical Officer of Mydecine Innovations Group Inc., which acquired Vancouver-based NeuroPharm Inc., a developer of natural psychedelic-based treatments for mental health disorders in the Canadian and United States veteran communities, earlier in the year.

In his role as CMO, Dr. Jetly — who is also an associate professor of psychiatry at Dalhousie University and at the University of Ottawa — is overseeing international research into the efficacy of psilocybin and psychedelic-assisted psychotherapy to treat veterans and first responders with a PTSD indication. And though the COVID pandemic has interrupted their work, Mydecine announced in November that it was expanding its Phase 2A clinical research to additional sites.

The company is working with researchers and institutions in Canada, including the University of Western Ontario and the University of Alberta, as well as Leiden University Medical Centre in the Netherlands, and is planning to include additional clinical sites in the U.S., Europe, and Australia.

“There seems to be this urgency for us to develop more effective novel treatments and maybe give people more choices if the traditional first-line evidence-based psychotherapy and exposure-based therapies don’t work,” Dr. Jetly says.

He offers a few hypotheses as to why PTSD in veterans can be difficult to treat.

There are often multiple traumatic episodes experienced by vets, rather than a single occurrence, he says, and rates of childhood trauma are often higher among those who join combat forces. Another factor to consider, Dr. Jetly says, is the concept of moral injury, first introduced by U.S. psychiatrist Dr. Jonathan Shay in the 1990s.

Shay offers a three-part definition of moral injury in his 1994 book Achilles in Vietnam: Combat Trauma and the Undoing of Character. “Moral injury is present when (1) there has been a betrayal of what is morally correct; (2) by someone who holds legitimate authority; and (3) in a high-stakes situation,” he writes.

Dr. Jetly explains moral injury as persistent guilt, shame, or anger as a result of transgressing values or highly-held beliefs. He offers the example of a soldier tasked with clearing a mine site, missing a mine, and then witnessing a convoy being killed as they attempt to navigate the area.

According to Dr. Jetly, traditional treatments for PTSD may not be as effective when the predominant problem is guilt and shame and that novel treatments, like psilocybin assisted psychotherapy, could be “better suited to help people to deal with this underlying feeling about themselves.”

“Maybe we can demonstrate through some of our studies, that there’s a fundamental shift in the way the brain and the mind are interpreting their environment, their sense of self, and which makes them more receptive to some of the therapeutic principles that are being performed,” he says.

In traditional treatment options for PTSD, Dr. Jetly says the medications offered, such as antidepressants, are to “quiet the noise” and allow psychotherapy to take place. He stresses that the Mydecine trials are not for a drug but rather a mode of treatment.

“It is not something that I ever really see where it’s ‘Here’s a pill, you’re going to feel better,’ because it really requires working through the trauma,” he says. “This is not a trial of Paxil or a trial of Prozac. This is a medication-assisted psychotherapy trial —  this is the substance with psychotherapy, that’s what we’re studying.”

Patients will undergo the psychedelic experience two to three times over a 16-week trial, Dr. Jetly explains.

“We believe that both the psychedelic and the psychotherapy together are the active ingredients that will lead to improved patient outcomes,” he says.

For Josh Bartch, chairman and CEO of Mydecine, he says he’s excited about the opportunity to be involved in something that could potentially be “revolutionary in the way that mental health is treated throughout military constituencies, whether that’s active military or, as in our case, starting with veterans.”

“These people come home from war, after fighting for our freedoms, and are essentially just left,” Bartch says. “There’s really no viable solution to fix this ailment in PTSD. In the United States, 22 veterans a day are committing suicide with PTSD, it’s a staggering number.”

In November, Mydecine announced that its subsidiary NeuroPharm Inc. had filed a provisional patent application in the U.S. for a “psychedelic therapy enhancer for the treatment of certain psychiatric disorders, including enhancements to treatments for PTSD.”

According to the release, the enhancer reduces the enzymatic breakdown of psilocin, the active ingredient in psilocybin that causes psychedelic effects. “This may result in an enhanced psychedelic experience in the treatment of PTSD, whether by extended in time, intensity, intensity per dose, or a combination thereof,” the release states.

Mydecine has also been approved by Health Canada to import and export, extract and analyze natural and synthetic psychedelic compounds.

“For us, we see it as a massive hole among people that need [treatment options],” Bartch says.

After being slowed by the global pandemic, Dr. Jetly is hoping the trials will be able to get back on track this spring.

At Leiden University in the Netherlands, one of the oldest universities in Europe, researchers are working on the first draft protocols, he says.

“It’s very exciting in terms of putting these ideas together,” he says. “We really want to demonstrate the safety and efficacy of psilocybin assisted psychotherapy. If we can bring something new to offer our veterans that have basically sacrificed body and mind for our countries, that’s really our goal.”

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Mydecine Innovations Group Partners with Microdose to Present a Webinar on Psychedelic Drug Development

Published at Pronewsreport.com

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Mydecine Speaker Series III

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Toronto, Ontario Feb 16, 2021 (Issuewire.com) –

Mydecine Innovations Group (CSE: MYCO) (OTC: MYCOF) (“Mydecine” or the “Company’), an emerging biopharma and life sciences company committed to the research, development, and acceptance of alternative nature-sourced therapeutic medicine for mainstream use, announced today that the Company has partnered with Microdose Psychedelic Insights (“Microdose”), a leader in B2B psychedelic intelligence, to present a free, three-part live video discussion series titled “Mydecine Speaker Series” covering Research, Psychedelic Therapies, PTSD, Microdosing, and Drug Discovery.

The Mydecine Speaker Series is dedicated to exploring the incredible findings around current psychedelic research and what the path to mainstream acceptance looks like. Moderated by Debra Borchardt, Green Market Report, Co-Founder and CEO., the panelists will discuss if Psychedelic Drug Design can Improve Safety and Efficacy for Medicine.

The third Mydecine Speaker Series event will feature Mydecine Scientific Advisory Board Member Dr. Denton Hoyer, Mydecine Innovations Group, Drug Discovery Consultant, the Chief Scientific Officer Robert Roscow, and Paul A. Frewen, Ph.D., C.Psych., University of Western Ontario, Associate Professor.

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Details and schedule of the third event are as follows:

 

Mydecine Speaker Series III – Drug Development: Can Psychedelic Drug Design Improve Safety and Efficacy for Medicine? starts on Thursday, Feb 18th, 2021 1:30 pm – 3:00 pm EST hosted by Mydecine Innovations Group Inc. moderated by Debra Borchardt, Green Market Report, Co-Founder and CEO.

 

Moderator:

Debra Borchardt, Green Market Report, Co-Founder and CEO

Debra Borchardt is the Co-founder and CEO of the financial news website Green Market Report. She is an award-winning journalist with a Masters’s Degree in Business Journalism from New York University. Debra worked alongside Jim Cramer for eight years before embarking on a solo career. Prior to becoming a financial journalist, Debra worked on Wall Street and was a Vice President at Bear Stearns, where she worked for 15 years.

 

Panel:

Robert Roscow, MA, Mydecine Innovations Group, Chief Scientific Officer & Co-Founder

Robert Roscow, MA (Chief Scientific Officer & Co-Founder). Mr. Roscow is a highly educated geneticist with an impressive knowledge of multiple arts of science. He has spent his academic and professional careers looking for valuable and unique active medicinal compounds found in nature. The last two companies Mr. Roscow applied his innovations to were Canopy Growth and ebbu where he was the head of their genetics divisions.

Mr. Roscow has already leveraged expertise in genomics, evolution, and molecular biology to maximize the industrial production of cannabinoids and their use in a pharmacological context. His work has resulted in multiple patent filings and accolades in publications ranging from Nature to Rolling Stone. Now, Mr. Roscow has set his focus on the vast healing potential of the safe and effective compounds found in fungi.

 

Paul A. Frewen, Ph.D., C.Psych., University of Western Ontario, Associate Professor

Paul Frewen joined the departments of psychiatry and psychology at the University of Western Ontario in London, Ontario, Canada in September 2008. He completed his doctorate in clinical psychology at Western and his post-doctoral residency at the Royal Ottawa Mental Health Centre. He has chaired the Traumatic Stress Section of the Canadian Psychological Association (CPA) and is the current chair of the practice committee of the American Psychological Association (APA) Psychological Trauma Division. He received the President’s Early Research Award from the CPA in 2010, Early Career Awards from the Traumatic Stress sections of the American and Canadian Psychological Associations in 2013 and 2014, and the Scientist-Practitioner Early Career Award from the CPA in 2014. He has authored over 100 peer-reviewed articles on the subjects of trauma, affect regulation, mindfulness, dissociation, and the self, primarily utilizing functional neuroimaging and psychometrics approaches.

 

Dr. Denton Hoyer, Mydecine Innovations Group, Drug Discovery Consultant

Dr. Hoyer has been involved in drug discovery at leading pharmaceutical companies and research institutions for the last 30 years. He holds numerous patents and has been published extensively in the field of medicinal chemistry and drug research. Dr. Hoyer has unparalleled expertise in computational chemistry enabled probe molecule design, drug design, and optimization, synthetic planning and execution, evaluation of chemical novelty, and intellectual property assessment and strategies. Dr. Hoyer is currently on the scientific advisory board at Mydecine Innovations Group.

 

Date:

February 18th, 2021 at 13:30 p.m. – 3:00 p.m. Eastern

Registration site:

https://microdose.buzz/shop/conferences/mydecine-speaker-series-part-iii/

 

Concept:

In each webinar, 3 to 4 featured thought leaders in the psychedelic space will give their expert perspective on the current and future research, findings, and their applications to the marketplace. The participants will engage in deep and intimate conversations followed by a Q&A period with the audience.

 

‍About Microdose Psychedelic Insights

Microdose Psychedelic Insights aims to unlock the potential of psychedelics through Industry events, market intelligence, original, evidence-based content, strategy, and community. We enable and empower society at large to make better, more mindful decisions about psychedelics and their intersection with healthcare, medicine and personal growth. We work with the industry’s most influential stakeholders, some of the world’s best-known brands and an unrivaled network of scientists, researchers, analysts, innovators, investors, and advisors.

 

About Mydecine Innovations Group

Mydecine Innovations Group (CSE: MYCO) (OTC:MYCOF) (FSE:0NFA) is an emerging biotech and life sciences company dedicated to developing and commercializing innovative solutions for treating mental health problems and enhancing vitality. The company’s world-renowned medical and scientific advisory board is building out a robust R&D pipeline of nature-sourced psychedelic-assisted therapeutics, novel compounds, therapy protocols, and unique delivery systems. Mydecine has exclusive access to a full cGMP certified pharmaceutical manufacturing facility with the ability to import/export, cultivate, extract/isolate, and analyze active mushroom compounds with full government approval throgh Health Canada. Mydecine also operates out of a state-of-the-art mycology lab in Denver, CO to focus on genetic research for scaling commercial cultivation of rare (non-psychedelic) medicinal mushrooms.

At the heart of Mydecine’s core philosophy is that psychedelic-assisted psychotherapy will continue to gain acceptance in the medical community with many of the world’s best-accredited research organizations demonstrating its remarkable clinical effectiveness. Mydecine recognizes the responsibility associated with psychedelic-assisted therapy and will continue to position itself as a long-term leader across the spectrum of clinical trials, research, technology, and global supply. Mydecine has also successfully completed multiple acquisitions since its inception.

Learn more at: https://www.mydecine.com/

Debra Borchardt
Robert Roscow
Denton Hoyer
Paul A Frewen
Posted on

Mydecine Innovations Group Announces Closing of $17,250,000 Bought-Deal Public Offering, Including Full Exercise of the Over-Allotment Option

Published at Yahoo!Finance

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Mydecine Innovations Group (CSE: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company’), an emerging biopharma and life sciences company committed to the research, development, and acceptance of alternative nature-sourced medicine for mainstream use, is pleased to announce the closing of its previously-announced bought-deal public offering led by Canaccord Genuity Corp. (“Canaccord” or the “Underwriter”) pursuant to which the Company issued 34,500,000 units of the Company (the “Units”) at a price of C$0.50 per Unit (the “Issue Price”) for aggregate gross proceeds to the Company of C$17,250,000 (the “Offering”), which includes the full exercise of the over-allotment option to purchase 4,500,000 Units at the Issue Price.

“We are excited about the closing of this financing. We greatly appreciate the interest and support from our investor base. This offering further strengthens Mydecine’s balance sheet and positions the Company for continued growth in 2021,” said Joshua Bartch, Chief Executive Officer of Mydecine.

Each Unit is comprised of one common share in the capital of the Company (a “Common Share”) and one Common Share purchase warrant (a “Warrant”). Each Warrant will be exercisable to acquire one Common Share (a “Warrant Share”) at any time until February 12, 2024 at an exercise price of $0.70 per Warrant Share.

The Warrants are expected to be listed for trading on the Canadian Securities Exchange commencing on Tuesday, February 16, 2021.

The Company plans to use the net proceeds of the Offering to invest in additional clinical trials, for expansion of its intellectual property portfolio, continued development of its drug pipeline, expanded research and development partnerships and initiatives and for general working capital purposes.

About Mydecine Innovations Group

Mydecine Innovations Group™ (CSE: MYCO) (OTC:MYCOF) (FSE:0NFA) is an emerging biotech and life sciences company dedicated to developing and commercializing innovative solutions for treating mental health problems and enhancing vitality. The company’s world-renowned medical and scientific advisory board is building out a robust R&D pipeline of nature-sourced psychedelic-assisted therapeutics, novel compounds, therapy protocols, and unique delivery systems. Mydecine has exclusive access to a full cGMP certified pharmaceutical manufacturing facility with the ability to import/export, cultivate, extract/isolate, and analyze active mushroom compounds with full government approval through Health Canada. Mydecine also operates out of a state-of-the-art mycology lab in Denver, CO to focus on genetic research for scaling commercial cultivation of rare (non-psychedelic) medicinal mushrooms.

At the heart of Mydecine’s core philosophy is that psychedelic-assisted psychotherapy will continue to gain acceptance in the medical community with many of the world’s best accredited research organizations demonstrating its remarkable clinical effectiveness. Mydecine recognizes the responsibility associated with psychedelic-assisted therapy and will continue to position itself as a long-term leader across the spectrum of clinical trials, research, technology, and global supply. Mydecine has also successfully completed multiple acquisitions since its inception.

Learn more at: https://www.mydecine.com/ and follow us on Facebook, Twitter, and Instagram.

For further information about Mydecine Innovations Group, Inc., please visit the Company’s profile on SEDAR at www.sedar.com or visit the Company’s website at www.mydecine.com.

The Canadian Securities Exchange has neither approved nor disapproved the contents of this news release and accepts no responsibility for the adequacy or accuracy hereof. This news release contains forward-looking information within the meaning of Canadian securities laws regarding the Company and its business, which relate to future events or future performance and reflect management’s current expectations and assumptions. Often but not always, forward-looking information can be identified by the use of words such as “expect”, “intends”, “anticipated”, “believes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would” or “will” be taken, occur or be achieved. Such forward-looking statements reflect management’s current beliefs and are based on assumptions made by and information currently available to the Company. Readers are cautioned that these forward-looking statements are neither promises nor guarantees, and are subject to risks and uncertainties that may cause future results to differ materially from those expected including, without limitation, risks regarding the COVID-19 pandemic, the availability and continuity of financing, the ability of the Company to adequately protect and enforce its intellectual property, the Company’s ability to bring its products to commercial production, continued growth of the global adaptive pathway medicine, natural health products and digital health industries, and the risks presented by the highly regulated and competitive market concerning the development, production, sale and use of the Company’s products. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information. These forward-looking statements are made as of the date hereof and the Company does not assume any obligation to update or revise them to reflect new events or circumstances save as required under applicable securities legislation.

This news release does not constitute an offer to sell securities and the Company is not soliciting an offer to buy securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. This news release does not constitute an offer of securities for sale in the United States. These securities have not and will not be registered under United States Securities Act of 1933, as amended, or any state securities laws and may not be offered or sold in the United States or to a U.S. Person unless so registered, or an exemption from registration is relied upon.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210212005314/en/

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Posted on

The Current Status of Psychedelics in Psychiatry

Published at jamanetwork.com

By David Nutt, MD, PhD and Robin Carhart-Harris, PhD

July 29, 2020

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In the 1950s, the Swiss pharmaceutical company Sandoz, which employed the chemist Albert Hofmann, who discovered lysergic acid diethylamide (LSD) and the similar serotonergic psychedelic psilocybin, made these drugs available to the psychiatric research community as the products Delysid and Indocybin, respectively. By the 1960s, these drugs had caused a revolution in brain science and psychiatry because of their widespread use by researchers and clinicians in many Western countries, especially the US. Before LSD was banned, the US National Institutes of Health funded more than 130 studies exploring its clinical utility, with positive results in a range of disorders but particularly anxiety, depression, and alcoholism. However, the displacement of LSD into recreational use and eventual association with the anti-Vietnam war movement led to all psychedelics being banned in the US. This ban became ratified globally under the 1971 UN Convention on narcotics. Since then, research funding, drug production, and the study of psychedelics as clinical agents has been virtually stopped. Until very recently, no companies would manufacture medical-grade psychedelics, which made getting regulatory approval for clinical research—especially clinical trials—very difficult and in some countries (eg, Germany) impossible.

The past decade has seen a resurrection in human psychedelic drug research, especially involving psilocybin. There were 2 drivers to this. The first was the discovery by Griffiths et al1 that a single high dose (25 mg) of psilocybin, given in a psychotherapeutic setting, produced enduring positive changes in mood and well-being in people who do not have depression. The second was our series2 of neuroimaging studies in healthy volunteers, which revealed that psilocybin produced profound and meaningful alterations in brain function, especially of the default mode network, consistent with an antidepressant effect. These findings suggested the possible utility of psilocybin for treating depression and initiated the launch of studies in the UK and US that further supported an antidepressant outcome from a single, 25-mg psilocybin dose in people with resistant depression3 and those with anxiety and depression symptoms provoked by life-threatening cancer diagnoses.4,5 There have also been open studies showing efficacy in both alcohol and tobacco dependence.6

Based on these positive findings, at least 2 companies have been set up to take psilocybin to the clinic by funding multicenter, dose-finding studies of psilocybin in depression, and a search of ClinicalTrials.gov (in April 2020) revealed that more than 30 psychedelic drug trials are registered (mostly with psilocybin, although a few are with LSD). These include studies in anorexia, obsessive-compulsive disorder, and addictions, as well as depression. At least 2 of the depression trials7,8 (those of COMPASS Pathways and Usona Institute) are randomized clinical trials compatible with the US Food and Drug Administration and European Medicines Agency registration processes and have been given fast-track status in this field. Many of the trials in other disorders are open-label designs to gather feasibility and safety data to underpin subsequent double-blind randomized clinical trials. Once these regulatory-standard trials have been conducted, if the outcomes are positive, then it seems plausible that psilocybin will become a licensed medicine for some forms of mental illness when used in an approved treatment model.

In the depression trials, the treatment model is becoming standardized as a 4-stage process: assessment, preparation, experience, and integration. Assessment determines if the patient is suitable for psychedelic therapy, both from a mental and physical perspective. Currently, people with a personal or family history of psychosis and bipolar disorder are excluded, as are those with significant health issues (eg, hypertension) because psychedelics transiently increase blood pressure. Certain medications need to be stopped or at least reduced before the treatment, because they can block or attenuate the effect of the psychedelic. Specifically, medicines that block 5-HT2A receptors (eg, amitriptyline, olanzapine, quetiapine, risperidone, trazodone) need to be withdrawn, and serotonin reuptake inhibitors ideally stopped or, if that is not feasible, tapered down, because they produce subsensitivity of the 5-HT2A receptor.

In modern studies,3–5 preparation sessions typically take place the day before the drug administration, the participant is prepared for the experience by at least 1 trained therapist, who are often referred to as guides, based on the analogy of the psychedelic experience being a psychological journey. An overview of the dynamics and nature of psychedelic experiences is explained, including how it can be challenging for many people, how any such challenges can be best confronted, and how the participant can get the most out of the experience. During the psychedelic experience, the individual is offered eyeshades and earphones to listen to a music compilation that has been prepared in advance (which they can specify) because music seems to enhance the therapeutic process. For oral psilocybin, the sessions last 4 to 5 hours. Verbal engagement with the therapists is not expected, and most patients go deep into their own visions, thoughts, and memories and do not want to be disturbed. But the guide or guides are present, and with permission, they can hold the patient’s hand to reassure the person that he or she is being looked after. The next day is the integration session—during which the same guide or guides talk through the experience and help the patient make sense of it. Ideally, a small number of standard, talk-based psychotherapeutic sessions are further available for issues that emerged during the psychedelic experience to be processed, insights to be further integrated, and guidance given on how best to cultivate positive cognitive and lifestyle changes.

In all of the treatment studies conducted so far, the psychedelic is given just once or twice over a few weeks with psychotherapeutic input (which, in the case of addictions, can be a standard 10-week to 20-week abstinence-based program). In this regard, psychedelic treatments are being considered as a new paradigm in psychiatric medicine—that of drug-facilitated psychotherapy.

Why might psychedelics work in such a wide range of disorders? We suggest this may be because these conditions are all internalizing disorders. In depression, patients continually ruminate about their failings, reiterate thoughts of guilt, and engage in self-critical inner narratives. In addiction, drug craving drives behavior that is specific, narrow, and rigid; individuals with addiction ruminate on the drug, including where to get it, how to pay for it, etc. In obsessive-compulsive disorder and anorexia, there is excessive rumination about threats to the person, from contamination or the effects of eating or overeating, respectively. Neuroimaging studies reveal that psychedelics probably work by disrupting brain systems and circuits that encode these repetitive thoughts and behaviors. The psychedelic experience opens a therapeutic window that disrupts entrenched thinking and allows insight, which with psychotherapeutic support can lead to a recalibration of one’s spectrum of associations.9

So far, the published trials of psychedelic therapy have yielded promising tolerability and efficacy data. Effect sizes have generally been greater than those of current treatments,3–5 although confirmation biases may be inflating these. Retention rates are excellent, and few adverse effects have been reported. Head-to-head comparative efficacy studies with current treatments are necessary to fully gauge how promising psilocybin therapy is in comparison with current treatments. In this vein, our research team will report the results of our psilocybin vs escitalopram comparison in major depression later this year.

Perhaps the major challenge is how to scale the treatment up. The current model is time and therapist intensive, and even though only a couple doses of medicine are required, this is currently costly because of the many regulatory challenges associated with psychedelics still being scheduled as very dangerous, illegal drugs under the UN Conventions and all Western governments’ drug laws. Another issue is how to provide enough psychedelic-trained therapists and ensure good practice through structuring, manualizing, monitoring, and delivering quality training and practice. Several of the centers currently researching psychedelic therapy are offering training under the supervision of more experienced therapists; for example, Kings College in London, in the UK, has successfully piloted group training of potential therapists, some of whom also received psilocybin as part of this course (though self-experience is not required). If this form of therapy does become more widely used, more formal training of large numbers of therapists will be required.

Article Information

Corresponding Author: David Nutt, MD, PhD, Imperial College London, Du Cane Road, Burlington Danes Building, London W12 0NN, United Kingdom (d.nutt@imperial.ac.uk).

Published Online: July 29, 2020. doi:10.1001/jamapsychiatry.2020.2171

Conflict of Interest Disclosures: Dr Nutt reported grants and personal fees from COMPASS Pathways during the conduct of the study. Dr Carhart-Harris reported serving as a scientific advisor to COMPASS Pathways, Usona Institute, Entheon Biomedical, Synthesis, and Mindleap.

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References

click here to read article references.

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