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Mydecine Reports Positive Pre-IND Meeting With FDA For MYCO-001 Smoking Cessation Study

Mydecine Reports Positive Pre-IND Meeting With FDA For MYCO-001 Smoking Cessation Study

Company rapidly prepares to submit IND and Breakthrough Therapy Status Applications

DENVER, March 01, 2022 (GLOBE NEWSWIRE) — Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company”), a biotechnology company aiming to transform the treatment of mental health and addiction disorders, today announced a positive meeting with the Food and Drug Administration (FDA) regarding their Investigational New Drug (IND) and breakthrough therapy status applications.

The Company reported a meeting with the FDA on February 28th to review their IND application to administer MYCO-001, in combination with therapy, to humans as part of smoking cessation treatment. Leading drug and substance abuse researcher, Dr. Matthew Johnson of Johns Hopkins University, will serve as the lead investigator for this multi-site study.

“The data from John Hopkins University’s ongoing studies assessing psychedelic-assisted therapy to treat nicotine addiction is showing efficacy rates 2-3 times higher than the current gold standard of treatment. Our team is eager to start collecting the data needed to bring an approved drug product to market that could potentially save millions of lives,” said Mydecine Chief Medical Officer Dr. Rakesh Jetly.

“Mydecine plans to submit a request for Breakthrough Therapy designation with our IND submission. Psilocybin-assisted therapy has shown meaningful advantages over available medications for tobacco addiction including significant increases in safety and efficacy. We are looking forward to closely working with the FDA to bring safer and more effective therapy to the millions of people who are trying to quit smoking across the globe,” said Mydecine’s Senior Director of Clinical and Regulatory Affairs, Jessica Riggleman.

“We had an extremely positive meeting with the FDA in regards to our proposed smoking cessation study. The FDA provided helpful feedback on our study design that we will implement. We are now working rapidly in preparing our IND submission for the 2B portion of the study which we believe will be next month. Once cleared, we will move swiftly into patient recruitment. This is a study we have been diligently working on over the last two years and we’re excited to continue moving it forward,” said Mydecine CEO Josh Bartch.

Sign-up for Mydecine’s newsletter by scrolling to the bottom of this page.

About Mydecine Innovations Group
Mydecine Innovations Group™ (NEO:MYCO) (OTC:MYCOF) (FSE:0NFA) is a biotechnology company developing innovative first- and-second-generation novel therapeutics for the treatment of mental health and addiction using world-class technology and drug development infrastructure. Mydecine was founded in 2020 to address a significant unmet need and lack of innovation in the mental health and therapeutic treatment environments. Our global team is dedicated to efficiently developing new therapeutics to treat PTSD, depression, anxiety, addiction and other mental health disorders. The Mydecine business model combines clinical trials and data outcome, technology, and scientific and regulatory expertise with a focus on psychedelic therapy, as well as other novel, non-psychedelic molecules with therapeutic potential. By collaborating with some of the world’s foremost authorities, Mydecine aims to responsibly fast-track the development of new medicines to provide patients suffering from mental health disorders with safe and more effective treatment options. Mydecine Innovations Group is headquartered in Denver, Colorado, USA, with international offices in Leiden, Netherlands.

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

For more information, please contact:
Media Contact
Morgan Kervitsky, Director of Marketing
pr@mydecineinc.com

Investor Relations
Morgan Kervitsky, Director of Marketing
contact@mydecineinc.com

On behalf of the Board of Directors:
Joshua Bartch, Chief Executive Officer
contact@mydecineinc.com

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.

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.

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XPhyto provides progress update on Psychedelic Medicine Programs and Novel Compounds Milestone

XPhyto provides progress update on Psychedelic Medicine Programs and Novel Compounds Milestone

Vancouver, Canada, and Uttenweiler, Germany (February 22, 2022) – XPhyto Therapeutics Corp. (CSE:XPHY / OTC:XPHYF / FSE:4XT) (“XPhyto” or the “Company”) is pleased to provide an update on its wholly owned subsidiary XPhyto Laboratories Inc. (“XPhyto Labs”). XPhyto Labs’ psychedelic medicine programs based in Edmonton, Canada, are focused on a multi-pronged approach to psychedelic medicine including GMP drug synthesis, proprietary drug delivery systems, novel psychedelic analogue engineering, and clinical validation.

Psychedelic Medicine – Canada

Through its exclusive contract R&D collaboration with Applied Pharmaceutical Innovation (“Applied”), first announced on February 3, 2021, XPhyto Labs is pursuing the application of psychedelic compounds as impactful solutions to mental health-related conditions.

Based on a systematic literature review, the Company identified mescaline (3,4,5-trimethoxyphenethylamine) as a promising candidate for the treatment of a broad range of mental disease states such as depression, anxiety, PTSD, and addiction, as well as cluster headaches. XPhyto and Applied developed a repeatable two-step reaction process with a yield greater than 60% and purity exceeding 99%, which is ideal for clinical use. Analytical methods were developed and validated and to date approximately 60 g of GMP grade mescaline has been manufactured for clinical trial evaluation.

With respect to mescaline drug delivery, XPhyto is focused on formulations designed to avoid common negative side-effects and provide precise and predictable dosage forms for clinical use. Mescaline is a naturally occurring psychedelic compound found in certain cacti, most notably peyote, San Pedro, and Peruvian Torch. These cacti are typically consumed via ingestion which has been associated with gastro-intestinal discomfort, nausea, and a lack of dosing predictability. The Company is pursuing a novel drug delivery system designed to prevent these common negative side-effects and complications; however, due to sensitivity related to intellectual property, further details cannot be disclosed at this time. The Company will announce further details in due course.

In addition to GMP mescaline synthesis and drug delivery, the Canadian operations are also focused on the design and synthesis of novel “2nd generation” psychedelic analogues. The Company has successfully developed and manufactured two promising novel compounds with properties designed to increase bioavailability. Intellectual property related information will be disclosed in due course.

XPhyto and Applied are developing a mescaline clinical trial strategy and are currently in the planning process for a robust Phase I clinical trial to commence in late 2022 to evaluate the safety and dosing parameters for mescaline-based treatment employing a proprietary drug delivery system. Details will be provided as decisions are finalized over the coming months.

“We see a lot of potential therapeutic value in psychedelic compounds for their ability to positively influence neural networks through growth and reorganization,” said Prof. Dr. Löbenberg, XPhyto director and founder and director of the Drug Development and Innovation Centre, University of Alberta. “Our focus is to develop production methodology for GMP manufacturing, proprietary drug formulations with precise, predictable and efficient API delivery for clinical investigation and therapeutic use of novel next-generation psychedelic compounds.”

Psychedelic Medicine – Germany

In addition to operations in Canada and in collaboration with a major German university, the Company is pursuing the development of industrial scale production methodology for GMP psilocybin through an advanced biosynthesis process focused on the insertion of genes from the psilocybin mushroom into certain bio-organisms. Gene insertion is complete and the micro-organisms are now producing psilocybin. The Company will announce further details in due course.

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Detox with Indigenous wisdom

Universal Ibogaine and Osoyoos Indian Band sign MOU to battle opioid crisis

Universal Ibogaine (IBO) and Osoyoos Indian Band signed an agreement to develop a detox center that combines western science and Indigenous wisdom.

The center will use ibogaine treatments to ease opioid cravings and withdrawal symptoms, followed by Indigenous healing practices as aftercare to “rebuild people in a holistic manner.”

Their flagship detox center will be in Manitoba, Canada with the goal of working with other First Nations to expand across the country, and then globally. 

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Universal Ibogaine Commences Development Plan At Kelburn In Preparation For Ibogaine Treatments And Provides Update On Drug Supply

Universal Ibogaine Commences Development Plan At Kelburn In Preparation For Ibogaine Treatments And Provides Update On Drug Supply

CALGARY, AB, Feb. 2, 2022 /CNW/ – Universal Ibogaine Inc. (TSXV: IBO) (“UI” or the “Company“) a life sciences company with a mission to deliver medicalized ibogaine-centered addiction treatment, has initiated development plans at its Kelburn treatment facility in preparation for treatment protocol approval and commencement of ibogaine treatments.

What is Ibogaine?

Ibogaine is a plant derived neuroactive compound that appears to reset the brains of drug dependent individuals to a pre-addicted state.  Ibogaine has demonstrated particular effectiveness in treating opioid use disorder.  When applied according to a strict safety protocol, ibogaine appears to eliminate the most painful symptoms of opioid withdrawal and provides a several month window free of drug cravings.  Dr Alberto Sola, co-founder of Universal Ibogaine has administered more ibogaine treatments than any other doctor in the world. 

Kelburn Addiction Treatment Center

Universal Ibogaine acquired the licensed and operational Kelburn Mental Health and Addiction Treatment facility in October of 2021.  The facility sits on a destination 50 acre estate with a 9 hole golf course and currently operates as a traditional addiction treatment center. 

Universal Ibogaine has undertaken plans to expand the facility to include traditional drug detox and to begin to incorporate the best in nuovo treatment modalities including Ketamine, Psilocybin and MDMA assisted psychotherapies. 

Universal Ibogaine has commenced development plans to construct a stand alone ibogaine detox facility on the property in preparation for the completion of its proof of concept study with Health Canada.


Dr Ian Rabb – Chief Clinics Officer

Dr Ian Rabb of Universal Ibogaine stated: “In my 20 years of addiction treatment, I have not seen anything with the power and promise of ibogaine to break the cycle of addiction.  When paired with a long term support plan, which we provide through our Kelburn facility, we expect to completely disrupt the addiction treatment model.  Ibogaine is legal in Canada under the prescription drug list and requires a proof of safety trial through Health Canada.  We are sitting on the edge of being able to tackle the opioid crisis head on.”

Drug Supply Update

Universal Ibogaine would also like to provide an update regarding the drug supply agreement with Psygen. The agreement was announced prematurely and contained some minor errors regarding the synthesis of the compound.  As a result, the parties to the agreement have withdrawn.

UI is currently in negotiations with two alternative drug suppliers.


About Universal Ibogaine Inc.
UI is a life sciences company, with a mission to demonstrate the safety and efficacy of its ibogaine based drug detox protocol through a Canadian Clinical Trial, and ultimately to utilize that protocol around the globe through future licensing agreements. UI is concurrently developing a state of the art holistic addiction treatment protocol at its Kelburn Clinic that, when paired with the ibogaine detox protocol, is intended to
revolutionize the way we treat addiction and drastically improve the lives of individuals and families affected by addiction.

NEITHER THE TSX VENTURE EXCHANGE NOR ITS REGULATION SERVICES PROVIDER (AS THAT TERM IS DEFINED IN THE POLICIES OF THE TSX VENTURE EXCHANGE) ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS


‎This news release may contain forward-looking statements and information. Forward-looking information is frequently characterized by words such ‎as “plans”, “expect”, “project”, “intend”, “will”, “believe”, “anticipate”, “estimate”, “scheduled”, ‎‎”potential”, or other similar words, or statements that certain events or conditions “may”, “should” or ‎‎”could” occur. The forward-looking statements and information are based on certain key expectations ‎and assumptions made by UI. Although UI believes that the expectations
and assumptions on which the forward-‎looking statements are based are reasonable, undue reliance should not be placed on the forward-‎looking statements because UI can give no assurance that they will prove to be correct.


Since ‎forward-looking statements address future events and conditions, by their very nature they involve ‎inherent risks and uncertainties. Actual results could differ materially from those currently anticipated ‎due to a number of factors and risks, which include, but are not limited to, risks that required ‎regulatory approvals are not obtained. The reader is cautioned that assumptions used in the ‎preparation of such information, although considered reasonable by UI at the time of ‎preparation, may prove to be incorrect
and readers are cautioned not to place undue reliance on ‎forward-looking information, which speaks only to conditions as of the date hereof. UI does not ‎undertake any obligation to release publicly any revisions to forward-looking information contained ‎herein to reflect events or circumstances that occur after the date hereof or to reflect the occurrence ‎of unanticipated events, except as may be required under applicable securities laws. ‎


For further information:


Investor Relations: Dugan Selkirk, IR Manager
dugan.selkirk@universalibogaine.com


Media Contact: Cathy Fernandes, Director – Marketing & Communications
cathy.fernandes@universalibogaine.com

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Mydecine Submits Pre-Investigational New Drug Briefing Package to the FDA for MYCO-001 Seamless Phase 2/3 Smoking Cessation Clinical Trial

Mydecine Submits Pre-Investigational New Drug Briefing Package to the FDA for MYCO-001 Seamless Phase 2/3 Smoking Cessation Clinical Trial

DENVER, Feb. 01, 2022 (GLOBE NEWSWIRE) — Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company”), a biotechnology and digital technology company aiming to transform the treatment of mental health and addiction disorders, today announced in preparation for its FDA pre-Investigational New Drug (IND) meeting on February 28th, the company has submitted a pre-IND briefing package to the U.S. Food and Drug Administration (FDA) for a clinical study evaluating MYCO-001 in a structured smoking cessation treatment program.

The study will be led by Principal Investigator Dr. Matthew Johnson, Ph.D., Professor of Psychiatry and Behavioral Sciences at Johns Hopkins University. The university is the flagship site of the planned placebo-controlled study, which will assess the safety and efficacy of psilocybin-assisted psychotherapy utilizing MYCO-001 to treat tobacco addiction.

“We are excited to move forward on this important study, and our team has been working diligently to ensure that our pre-IND package is complete,” said Mydecine CEO Josh Bartch. “Tobacco use is the greatest single, preventable cause of death in the world,” he added, “yet there are few safe and effective treatments for nicotine addiction. As the only company currently investigating a psilocybin compound for smoking cessation, Mydecine is proud to be at the forefront of this research.”

The planned study will build on previous smoking cessation studies conducted by Dr. Johnson and his team at Johns Hopkins University. In their ongoing trial, 59% of participants who received psychedelic-assisted therapy remained abstinent from smoking at 12 months, compared to only 28% of patients who received the transdermal nicotine patch.

Mydecine’s Phase 2/3 study is projected to launch in Q2 2022 and will be looking at primary endpoints of three and six months. A combined-phase or operationally seamless clinical trial, such as this one, combines two or more phases into one study and uses results acquired throughout the trial to adjust the course of the study. This design can use resources more efficiently and often can be more informative than a traditional fixed study.

“Even with a wide variety of approved treatments on the market, tobacco addiction continues to remain largely untreated,” added Mydecine CMO Dr. Rakesh Jetly. “With safety and efficacy concerns about current therapies, including the recall of the blockbuster treatment Chantix, there is a strong need for innovative and improved treatment options.”

According to the Centers for Disease Control and Prevention (CDC), cigarette smoking is responsible for one out of every five deaths in the United States, roughly 480,000 people every year. Approximately 34.1 million Americans currently smoke cigarettes. About 68% have stated they would like to quit smoking, and 55% have made an attempt to quit, yet only 7.5% are successful.

Sign-up for Mydecine’s newsletter by scrolling to the bottom of this page.

About Mydecine Innovations Group
Mydecine Innovations Group™ (NEO:MYCO) (OTC:MYCOF) (FSE:0NFA) is a biotechnology and digital technology company developing innovative first- and-second-generation novel therapeutics for the treatment of mental health and addiction using world-class technology and drug development infrastructure. Mydecine was founded in 2020 to address a significant unmet need and lack of innovation in the mental health and therapeutic treatment environments. Our global team is dedicated to efficiently developing new therapeutics to treat PTSD, depression, anxiety, addiction and other mental health disorders. The Mydecine business model combines clinical trials and data outcome, technology, and scientific and regulatory expertise with a focus on psychedelic therapy, as well as other novel, non-psychedelic molecules with therapeutic potential. By collaborating with some of the world’s foremost authorities, Mydecine aims to responsibly fast-track the development of new medicines to provide patients suffering from mental health disorders with safe and more effective treatment options. Mydecine Innovations Group is headquartered in Denver, Colorado, USA, with international offices in Leiden, Netherlands.

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

For more information, please contact:
Media Contact
Morgan Kervitsky, Director of Marketing
pr@mydecineinc.com 

Investor Relations
Morgan Kervitsky, Director of Marketing
contact@mydecineinc.com 

On behalf of the Board of Directors:
Joshua Bartch, Chief Executive Officer
contact@mydecineinc.com 

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.

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.

Primary Logo

Source: Mydecine Innovations Group Inc.

Released February 1, 2022

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The psychedelic that’s already in our brains

Did you know that one of the most promising addiction treatments is a psychedelic compound that’s found throughout nature and is present within the human body?

It’s called DMT (N,N-Dimethyltryptamine) and is thought to be produced in the brain’s pineal gland. It’s released in large amounts when we dream and when we die.  

Learn what leading DMT experts have discovered at the Daily Mushroom + Entheon Biomedical Mental Health Town Hall on Thursday, Feb. 3rd. Register now for free to get the inside scoop.

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Awakn Life Sciences Files Patent Application For A New Class Of Entactogen-Like Molecules To Treat A Broad Range Of Addictions

Awakn Life Sciences Files Patent Application For A New Class Of Entactogen-Like Molecules To Treat A Broad Range Of Addictions

Novel Entactogen NCE series enhances the potential for improved treatment of addiction

TORONTO, CANADA, 26 January 2022 – Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) (‘Awakn’), a biotechnology company, researching, developing and delivering psychedelic therapeutics to treat addiction, announces the filing of a patent application for a new chemical series of entactogen-like molecules, further strengthening Awakn’s intellectual property portfolio and pipeline for the treatment of a broad range of addictions including, but not limited to substance addictions such as Alcohol, and behavioural addictions, such as Gambling Disorder and Compulsive Sexual Behaviour.

The new chemical series patented by Awakn, delivers a significant step forward in the development of entactogens and provides a key milestone in Awakn’s drug discovery R&D activities. Awakn’s innovative pipeline of NCE’s further adds to existing patent applications and active clinical development programmes (KARE: completed phase-IIa/b trial and BIMA: completed phase-IIa trial), strengthens Awakn’s position as a global leader in the psychedelic-biotechnology industry.

Chief Scientific Officer at Awakn, Shaun McNulty commented, “The new chemical series of entactogen-like molecules being developed at Awakn will deliver the best characteristics of existing entactogens, with a shorter duration of action. This can improve clinical utility in a research space and has significant potential for the delivery of the treatments. These improved entactogens will enable us to treat more patients and has the potential to increase the range of disorders we can treat.  This will enable us to make rapid progress towards treating a broad range of addictions, a condition with huge unmet medical needs and significant negative impact on society.”

Awakn announced in October they would progress the NCE program into lead optimization with their research partner Evotec. These novel entactogen-like molecules which the patent has been filed for will be an integral part of this research program, with the aim to develop one or more compounds and progress them into clinical development. 

Anthony Tennyson, Awakn’s CEO commented, “Our ambition is to fully integrate effective psychedelic-based treatment into mainstream healthcare to better treat addiction. We are fortunate to have many of the world’s leading researchers and drug discovery experts supporting and delivering our vision at Awakn. Our clinical team has unparalleled experience in treating addiction, and now with the development of a new entactogen series and a world-class entactogen discovery pipeline, Awakn’s place as a global leader in this space is strengthened.”

About Awakn Life Sciences Corp.

Awakn Life Sciences is a biotechnology company, researching, developing, and delivering psychedelic therapeutics to better treat addiction. Awakn’s team consists of world leading chemists, scientists, psychiatrists, and psychologists who are advancing the next generation of psychedelic drugs and therapies to be used in combination.

Awaknlifesciences.com  |  Twitter  |  LinkedIn  |  Facebook

Notice Regarding Forward Looking Information

This news release contains certain forward-looking information and forward-looking statements, as defined in applicable securities laws (collectively referred to herein as “forward-looking statements”). Forward-looking statements reflect current expectations or beliefs regarding future events or the Company’s future performance. All statements other than statements of historical fact are forward-looking statements. Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “continues”, “forecasts”, “projects”, “predicts”, “intends”, “anticipates”, “targets” or “believes”, or variations of, or the negatives of, such words and phrases or state that certain actions, events or results “may”, “could”, “would”, “should”, “might” or “will” be taken, occur or be achieved, including statements relating to the proposed NEO listing, and the business of the Company. All forward-looking statements, including those herein are qualified by this cautionary statement.

Although the Company believes that the expectations expressed in such statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results or developments may differ materially from those in the statements. There are certain factors that could cause actual results to differ materially from those in the forward-looking information. These include: whether conditions to the listing on NEO will be satisfied; the business plans and strategies of the Company, the ability of the Company to comply with all applicable governmental regulations in a highly regulated business; the inherent risks in investing in target companies or projects which have limited or no operating history and are engaged in activities currently considered illegal in some jurisdictions; changes in laws; limited operating history; reliance on management; requirements for additional financing; competition; inconsistent public opinion and perception regarding the medical-use of psychedelic drugs; and regulatory or political change. Readers are cautioned that the foregoing list of factors is not exhaustive of the factors that may affect forward-looking statements. Accordingly, readers should not place undue reliance on forward-looking statements. The forward-looking statements in this news release speak only as of the date of this news release or as of the date or dates specified in such statements.

Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking information. For more information on the Company, investors are encouraged to review the Company’s public filings on SEDAR at www.sedar.com. The Company disclaims any intention or obligation to update or revise any forward- looking information, whether as a result of new information, future events or otherwise, other than as required by law.

This news release does not constitute an offer to sell, or a solicitation of an offer to buy, any securities in the United States. The Company’s and Awakn’s securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”) or any state securities laws and may not be offered or sold within the United States or to U.S. Persons unless registered under the U.S. Securities Act and applicable state securities laws or an exemption from such registration is available.

Investor Enquiries:

KCSA Strategic Communications 
Valter Pinto / Tim Regan 
Phone: +1 (212) 896-1254
Awakn@KCSA.com

Media Enquiries:

America and Canada: KCSA Strategic Communications  
Anne Donohoe 
Adonohoe@KCSA.com

Rest of World: ROAD Communications 
Paul Jarman / Nora Popova
Awakn@roadcommunications.co.uk

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Be an industry insider

How can DMT be improved to better treat addiction? How do our genetics influence our psychedelic experiences? How does ketamine change our brain wave patterns? Does music make psychedelic therapy more effective?

These are all questions that Entheon Biomedical (ENBI) is answering with ongoing clinical research. Learn what they’ve discovered so far and their next steps at our Mental Health Town Hall this February 3rd!

We’ll be joined by Entheon’s Founder and CEO, Scientific Advisor, and Communications Manager to discuss the company’s findings and the future of psychedelic therapy. Click here to register for free to get the inside scoop.

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Awakn Life Sciences Signs MOU With MAPS

Awakn Life Sciences Signs MOU With MAPS

Agreement to explore a partnership for MDMA-Assisted Therapy for treatment of Alcohol Use Disorder in Europe

TORONTO, CANADA, 19 January 2022 – Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) (‘Awakn’), a biotechnology company developing and delivering psychedelic therapeutics (medicines and therapies) to treat Addiction, announced today it has signed a Memorandum of Understanding (“MOU”) with the Multidisciplinary Association for Psychedelic Studies (MAPS) to explore a partnership to utilize MDMA-assisted therapy to treat Alcohol Use Disorder (AUD) in Europe. 

Under the terms of this MOU, Awakn will explore a data licensing agreement with MAPS to support Awakn’s Phase IIb and planned Phase III studies for MDMA-assisted therapy for AUD in Europe. Awakn and MAPS will also assess a partnership to secure marketing authorisation/regulatory approval for the ethical commercialization of MDMA-assisted therapy for the treatment of AUD in Europe. 

AUD is a chronic disease affecting 40 million people in Europe and 390 million people globally. It is also a pervasive and persistent public health issue, with alcohol use being one of the top five causes of disease and disability in the majority of countries in Europe. And for each person suffering from AUD, there is a friend, a partner, or a family also deeply affected by it.

In February 2021, Awakn announced the publication of the successful results of the BIMA Phase IIa study investigating MDMA-assisted therapy for the treatment of AUD, reporting a 21% relapse rate at 9 months in comparison to a 75% relapse rate in a separate observational group.

In May 2021, MAPS announced that it achieved successful results in its first of two Phase III trials for MDMA-assisted therapy for the treatment of severe chronic PTSD. In this study, 88% of participants who received three MDMA-assisted therapy sessions – along with twelve 90-minute, non-drug preparation and integration therapy sessions – experienced a clinically meaningful reduction in symptoms. 67% of participants no longer qualified for a PTSD diagnosis.

“MAPS’ role in driving and advancing the use of psychedelics in the clinical setting over the last 35 years is second to none,” said Anthony Tennyson, Awakn’s CEO. “We believe that by licensing MAPS’ pre-clinical data and exploring options for future ethical commercialisation, we will improve the timeline and path to market for these life-changing treatments for AUD, providing hope for those for whom the status quo is not working.” 

“MAPS has been working with AWAKN scientists for decades in the effort to initiate trials into a range of clinical uses of MDMA-assisted therapy,” shares Rick Doblin, Founder and Executive Director of MAPS. “We’re delighted to be entering into this MoU with AWAKN which holds great promise for people suffering from AUD.”

Awakn also recently announced groundbreaking results from its Phase IIa/b ‘Ketamine for the Reduction of Alcoholic Relapse’ (KARE) clinical trial. It was the first controlled study in the world to investigate Ketamine-assisted therapy for the treatment of AUD and was published in the American Journal of Psychiatry in January. The study, conducted by the University of Exeter (UoE) and led by Prof. Celia Morgan, Professor of Psychopharmacology at UoE and Awakn’s Head of Ketamine-Assisted Therapy for addiction showed that ketamine and psychological therapy resulted in an 86% abstinence rate 6 months post treatment, an increase from 2% before the trial.

“This is another milestone in the advancement of successfully treating Alcohol Use Disorder,” said Awakn CMO Dr. Ben Sessa. “Currently there are millions suffering with very few promising lasting treatments and be it with MDMA or Ketamine-Assisted Therapy, we are exploring every promising avenue to treat a disease that not only impacts the individual, but also families and communities.”

NOTE

The safety and efficacy of MDMA-assisted therapy is currently under investigation. It has not yet been approved by medical regulators, does not work for everyone, and carries risks even in therapeutic settings. These statements are no guarantee of future regulatory approval or availability of MDMA-assisted therapy. These statements necessarily involve known and unknown risks and uncertainties, which may cause actual outcomes to differ materially from our projections.

About MAPS

Founded in 1986, MAPS is a 501(c)(3) non-profit research and educational organization that develops medical, legal, and cultural contexts for people to benefit from the careful uses of psychedelics and marijuana. MAPS is sponsoring the most advanced psychedelic therapy research in the world: Phase 3 clinical trials of MDMA-assisted therapy for PTSD. Since its founding, MAPS has raised over $130 million in donations and grants for psychedelic and marijuana research and education and has earned both the Guidestar Platinum Seal of Transparency and a 4-Star Rating from Charity Navigator. Learn more at maps.org.

About Awakn Life Sciences Corp.

Awakn Life Sciences is a biotechnology company, researching, developing, and delivering psychedelic therapeutics to better treat addiction. Awakn’s team consists of world leading chemists, scientists, psychiatrists, and psychologists who are advancing the next generation of psychedelic drugs and therapies to be used in combination.

 www.awaknlifesciences.com  |  Twitter  |  LinkedIn  |  Facebook

Notice Regarding Forward Looking Information

This news release contains certain forward-looking information and forward-looking statements, as defined in applicable securities laws (collectively referred to herein as “forward-looking statements”). Forward-looking statements reflect current expectations or beliefs regarding future events or the Company’s future performance. All statements other than statements of historical fact are forward-looking statements. Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “continues”, “forecasts”, “projects”, “predicts”, “intends”, “anticipates”, “targets” or “believes”, or variations of, or the negatives of, such words and phrases or state that certain actions, events or results “may”, “could”, “would”, “should”, “might” or “will” be taken, occur or be achieved the intended business of the Company, the expansion of the Company’s business, generation of revenue. All forward-looking statements, including those herein are qualified by this cautionary statement.

Investor Enquiries:

KCSA Strategic Communications 
Valter Pinto / Tim Regan 
Phone: +1 (212) 896-1254
Awakn@KCSA.com

Media Enquiries:

America and Canada: KCSA Strategic Communications  
Anne Donohoe 
Adonohoe@KCSA.com

Rest of World: ROAD Communications 
Paul Jarman / Anna Ramsey
Awakn@roadcommunications.co.uk