Benzinga – Entheon Acquires Pre-Testing Genetics Platform For Psychedelic Treatment

Psychedelics biotech company Entheon Biomedical Corp. (CSE:ENBI) has purchased biotech company HaluGen Life Sciences Inc. in an all-stock transaction.

Entheon acquired 100% of HaluGen in exchange for 5.1 million Entheon shares.

Why Genetic Testing Is Important: Psychedelic compounds have gained significant attention in recent years for their potential to treat multiple mental health conditions including major depressive disorder, anxiety, PTSD and addiction.

However, psychedelic drugs have been found to trigger psychotic episodes in individuals with a genetic predisposition to conditions in the psychotic spectrum, like schizophrenia and bipolar I or II disorders.


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HaluGen is attempting to commercialize a test to help identify genetic traits predictive of a patient’s reaction to hallucinogenic drugs. Its platform is expected to help evaluate an individual’s sensitivity and risk profile before the initiation of a treatment using psychedelic drugs.

Entheon CEO Timothy Ko says the acquisition will improve the company’s tools to screen patients for underlying psychiatric disorders prior to undertaking psychedelics assisted psychotherapy (PAP), and gather data linking genetics to outcomes.

“By adding this layer of personalized medicine and data, we seek to add an additional measure of safety and predictability to PAP, and to aggregate data that can be used to infer appropriateness of specific molecules in PAP,” Ko said.

Technology Networks

Substance use disorders have a debilitating impact on the wellbeing of individuals and their families. Like many other mental health disorders, these conditions have proved stubbornly resistant to treatment. The potential of psychedelic compounds to treat substance use disorders has led Canadian R&D company Entheon Biomedical to investigate the therapeutic use of the psychedelic dimethyltryptamine (DMT). The company has commissioned a clinical trial investigating the safety and efficacy of intravenous DMT. Technology Networks spoke to Entheon’s CEO, Timothy Ko, to find out more.

Ruairi Mackenzie (RM): What will be involved in the first stage of your DMT clinical trial?

Timothy Ko (TK):
 We have a clinical study agreement in place with a contract research organization, the Centre for Human Drug Research (CHDR) located in Leiden, Netherlands, to conduct an early phase clinical trial with DMT on humans. The objective of the study is to evaluate the safety of DMT in humans and, specifically, we’re looking to better understand the pharmacodynamics and pharmacokinetics of DMT when administered intravenously.

This will be a data-centric clinical trial, gathering vital information on the biochemical and physiological changes that occur when DMT is administered. This trial will give us further insight into the drug’s effects on the central nervous system and its impact on subjective experience, providing not only pharmacokinetic/pharmacodynamic but also a host of other valuable biometric data. All of this is critical to properly understand DMT’s potential as part of a therapeutic protocol to treat substance use disorders.

RM: What do you see as the unique challenges in treating substance abuse disorders in comparison to other mental health disorders?

TK: 
The success rates of current treatments and interventions are dismal, and as a society, we have become conditioned to accept these low rates of success as a foregone conclusion. We want to turn those assumptions upside down – to invert the addiction-recovery ratio and we believe we can do it through the development of a DMT-based therapeutic protocol.

Substance-use disorder is obviously a very complicated situation for both the individual grappling with it and for a society and public health system that is tasked with addressing and remedying the devastating effects and widespread damage that stems from unchecked substance-use disorder. With no straightforward solution present, our belief is that a medicalized, psychedelic-assisted therapy model provide a powerful tool for substance-use sufferers to gain the clarity and support required to reclaim their lives.

RM: How is DMT well placed to meet those challenges?

TK:
 Through extensive talks with our scientific advisors, a review of the literature and historical studies, DMT emerged as our ideal candidate for addiction treatment. DMT belongs to a class of psychedelic compounds, including psilocybin and LSD, which have shown high therapeutic value, and it is the psychoactive ingredient in ayahuasca. Being endogenous to the human body, DMT can be found in many plant species, and throughout its research history DMT has demonstrated a strong safety and toxicology profile. In addition, DMT is rapidly metabolized, so it is well-suited for a shorter, more tailored therapy experience, which has the added benefit of decreased costs and increased scalability. The ability to maintain a flexible and short therapy duration provides an element of control that cannot presently be achieved with other longer-lasting psychedelics. DMT is short-acting, powerful and has demonstrated safety in humans. These are the core reasons why we chose to focus our efforts on DMT.

RM: Do you believe that DMT will prove efficacious for all substance use disorders, or will it treat certain disorders more effectively?

TK: 
Our initial target indications will be nicotine addiction, alcohol-dependency and opioid use disorder. That being said, our DMT-assisted therapeutic protocol is being designed to address the core mechanisms underlying drug-seeking and using behaviour. Understanding that these drug-seeking behaviours are generated from a complex psychological and emotional place, DMT holds promise to directly address this base state, from which all manner of substance-use disorders are thought to originate from. From this standpoint, our aim is to prove efficacy for the initial target indication and then expand to focus on additional indications and substance-use disorders.

RM: What is the timeline for your DMT trial? How soon do you believe psychedelic-based therapeutics could be widely available?

TK:
 Recognizing the potential constraints of the ongoing coronavirus pandemic, we currently anticipate that our clinical trial at CHDR will commence in Q3 of 2021. We are doing everything we need logistically to ensure our trial remains on track.

Recently we announced our DMT drug-supply agreement with Psygen Labs, and that they have successfully completed production of our DMT research batch. This represents a major step in our clinical pathway, as the commencement of clinical trials and preparation hinges on having a consistent and high-quality drug supply. Once all necessary permits and licenses are in place, our drug-supply will be shipped to CHDR for requisite testing and formulation.

We are proving the safety and efficacy of our treatment protocol through standard regulatory channels that traditional drug developers go through – the FDA, EMA, and Health Canada. We expect that given our current trajectory, we would like to be in the final stages of clinical development and ready to seek final approvals and pursue commercialization in 4-5 years. But really, given the pressing need for effective treatments, paired with the growing loss of life from overdose, and the significant social and economic impact of substance-use disorders, an effective and scientifically validated solution cannot come quickly enough.

Timothy Ko was speaking to Ruairi J Mackenzie, Science Writer for Technology Networks

Tonic Magazine

Using Psychedelics To Treat Addictions

5 Questions About The DMT Molecule

Jamie Bussin and Timothy Ko

In Episode #162 of THE TONIC Talk Show,  the CEO of Entheon Biomedical spoke about the efficacies of treating addictions with stabilized DMT molecules. This is an excerpt from that interview. The full interview can be found at www.thetonic.ca

I think what’s driving this is the faults within the current medical system’s treatment of substance use and abuse. Our work addresses the limitations of the current medicalized treatment model for treating substance disorder. Societally we’re all bearing witness to those failures. In Vancouver alone, we have overdose deaths at a rate of 120 to 180 persons per month. Drug addictions and substance disorders tear at the fabric of society at every imaginable level. Hospital costs and policing is a drain. On a personal level it’s destructive to individuals and their families. All of the conventional models of treatments are extremely low on the efficacy rates,  as low as 5 to 10%. Stand-alone treatments for individuals can cost from $5,000 to $30,000;  some drug users will have 6 drug treatment stents in their life – often resulting in death.

Your company, Entheon, is taking a different approach. What is that? Trying to stabilize the patient with a variety of things. Whether it’s medication such as antidepressants, antipsychotics and psychedelics, so that they can do some introspective work such as psychotherapy, a 12 step-like therapy, with a view to assessing their internal make up, what their barriers are, what their catchments are so that they can rework that and get to a place of meaningful reformation of their internal characteristics and from there their behaviors will change. But the reality is that for a lot of drug abusers there is this intractable trauma that makes conventional methods difficult. As you delve deeper into their core truths, the trauma patients tend to retreat even further even into dissociation. We understand with psychedelics, that really key component of creating profound introspection, that epiphanic unearthing of core truths can’t just be delivered without context of a psychotherapy environment. We’re creating that network of support that precedes and follows the psychedelic experience to help optimize integration of that experience so the individual can have some consolidation, recontextualizing who they are, their belief systems, what motivates them and breaking through their traumatic barriers so they can have different behaviours, that aren’t driven by pain or fear.

Why are you using the DMT molecule for this purpose? DMT is the active ingredient in Ayahuasca – a psychoactive “jungle brew” employed generally in South American cultures to treat “diseases of despair” – the existential feeling of being lost. The Ayahuasca experience creates this massively profound introspective journey where the individual will have these deeply personal experiences. One of the limitations of Ayahuasca is that it is very difficult to create repeatable, precise doses for medical purposes. We’re taking a purely synthetic version of DMT and administering it in a safe, gradual and precise way that is controllable by a physician. The Ayahuasca experience can take 6-12 hours during which the individual may have an overwhelmingly difficult situation they may not be prepared for – there is no “off switch”. Whereas our approach is via a regulated intravenous pump. If the experience gets too intense, we can modulate the dosing or even stop it altogether, with a return to baseline functions within 15-20 minutes. The patients arrive at that therapeutic place gradually. We’re using the right molecules delivered in the right way so that we can create a very customized, safe experience.

Explain a little bit about the regulatory process you’ve gone through.  Even though psychedelics are in a unique space, novel in some regards, the reality is that the population that we’re trying to help are medicalized. They have medical disorders. The traditional drug discovery pathway that exists for other pharmaceutical companies exists for us too.  So we’re engaged in all the necessary clinical trial steps and we’re engaging all the necessary regulators like Health Canada, the FDA and the European agency when appropriate. We have signed our clinical trials agreement with our research partner in the Netherlands. We also have our GMP production agreement signed. We anticipate having all the pieces in place for human clinical trials in Q3 or Q4.

I understand that the work Entheon is doing is very personal for you. Everyone has probably been affected by knowing someone with addictions. My story is no different. My brother was a longtime drug user, since the age of 17. He suffered a traumatic event in his teens, and his way of coping was to take up drugs. Initially it started pretty innocently. But over the course of two decades that drug use did escalate to being highly problematic and apparent and involved over 8 treatment attempts. He was medicated. He spent hundreds if not thousands of hours with therapists. For two years I was responsible for overseeing my brother’s care. I saw well intentioned professionals earnestly trying to help my brother, but he slipped further into a state of dissociation and we lost him eventually. I’ve used DMT and have undergone psychotherapy to help me work through my own traumatic issues relating to my family of origin and my relationship with my brother and my father – issues woven into the fabric of who I was. DMT really did help me reformat my understanding of my attachments and resentments, my outlook on life. I was teetering on the edge of something very dark and I’m so lucky that I found out what was on the other side of that.

For more information about Timothy Ko and his work at Entheon Biomedical please visit entheonbiomedical.com

INN: Psychedelics Outlook 2021: How Far Can This Industry Go?

Click here to read the previous psychedelics outlook. 

With interest in psychedelics investing starting to gain steam, companies and experts continue to point to the long road ahead in 2021 and beyond for the market.

Investor patience and belief in the sector will be tested as companies continue the arduous task of proving the efficacy of psychedelic drugs. While money-making opportunities will appear, new drug development programs will still take significant time.

Following the most critical year for psychedelics investment, how will 2021 stack up in the grand scheme and what’s at stake for investors?

Here the Investing News Network (INN) offers investors a look at what’s to come for the new segment in 2021 directly from experts and those involved in this space.

Psychedelics outlook 2021: What should investors know before diving in?

New marketplaces can be challenging to jump into, and psychedelics is no different. So far executives and experts agree in recommending a long-term approach to investors.

“Drug development takes time and is capital intensive, so investors should focus on those companies that are sufficiently capitalized and have a team with a strong track record to bring these treatments to market,” Doug Drysdale, CEO of Cybin (NEO:CYBN), told INN.

Drysdale’s comment hints at the psychedelics industry’s biggest identifier, which is that it is most closely related to the often slow-paced life science sector. According to one executive, this means companies’ plans will require significant time to develop.

“In many regards, we, and many other companies in the space, are traditional biotechpharmaceutical and drug discovery firms, advancing psychedelic molecules through the conventional and established scientific, regulatory and legal framework required to bring any drug to a mass market,” said Timothy Ko, CEO at Entheon Biomedical (CSE:ENBI).

While companies may still perform as they work through these long pipelines, many experts cautioned that investors will not see a new rush similar to the one seen previously in Canada’s cannabis arena.

“It is a drug discovery, mental health, biotech play — not recreational and not cannabis,” Bill O’Hara, managing partner at LACG Capital and former managing director of institutional equity sales with Haywood Securities, explained to INN.

Ko agreed with O’Hara, telling INN that he thinks one of the biggest misconceptions in the psychedelics industry is that it is similar to the cannabis space.

Kelsey Ramsden, president and CEO of Mind Cure Health (CSE:MCUR,OTCQB:MCURF), said investors should pay close attention to the revenue horizons for companies in the space, and should also look for strong management teams and unique strategies.

“I think this will help investors land safely with companies who will create realizable value,” she said.

Psychedelics outlook 2021: Could big acquisitions be on the way in 2021?

With increased investor attention and potential upcoming medical approvals quickly changing the realities of the psychedelics space, one question has started to gain steam in this market: How likely is it for a big-name pharmaceutical entity to eye an early entry?

“It’s sort of becoming impossible to ignore in terms of the scientific evidence that’s accruing … and the potential that these compounds have for treating mental health conditions,” Adele Byrne, senior analyst with drug research firm Prohibition Partners, told INN.

During an online forum in August, Kris Miks, partner at Norton Rose Fulbright Canada, went so far as to say that major entries will be born out of companies’ desire to not be left behind.

“I think there’s going to be more of an appetite and more of an interest from large pharma to get into the space early and see if they can get involved,” Miks said at the time.

While the industry awaits a potential entry, it is undeniable that the sector has already seen significant investment from large figures in the market at large. Players like Peter Thiel, Kevin O’Leary and Bruce Linton have all thrown their support behind the psychedelics opportunity.

“Psychedelics are finally having their day in the sun — not as recreational drugs but as medicines to address society’s problems with mental illness and addiction — and I’m one of the many Wall Street investors who are now backing them,” O’Leary wrote in an op-ed.

When it comes to predictions, Leonard Lerer, CEO and founder of Back of the Yards Algae Sciences, a sustainable biotechnology firm that has committed to the benefits of entheogens, said 2021 may bring big opportunities for mergers and acquisitions.

“In 2021, we will see the first serious moves by the biopharmaceutical giants in this space,” Lerer said.

Josh Bartch, CEO of Mydecine Innovations Group (CSE:MYCO), told INN he sees next year as an opportunity for knowledge about psychedelic substances to grow.

“We see 2021 as a year of progress and continued public acceptance. With numerous clinical and R&D initiatives happening globally, much-needed information and discoveries will be uncovered during the upcoming year,” Bartch said.

Psychedelics outlook 2021: Investor takeaway

The psychedelics investment market is on pace to keep expanding and commanding the attention of more investors in 2021. With this uptick in attention, the industry will have to continue delivering results and proof of its promise in treating various mental health conditions.

As with any new market, it’s important for investors to remember that these are still the early days, and with this particular space the key theme is how much time it will take to mature.

“We have only just begun, there are a lot of companies entering the space who will not be here a year from now — the beginning of a new segment is always like this,” Ramsden said.

Don’t forget to follow @INN_LifeScience for real-time updates!

Securities Disclosure: I, Bryan Mc Govern, hold no direct investment interest in any company mentioned in this article.

Editorial Disclosure: Cybin and Mind Cure Health are clients of the Investing News Network. This article is not paid-for content.

The Investing News Network does not guarantee the accuracy or thoroughness of the information reported in the interviews it conducts. The opinions expressed in these interviews do not reflect the opinions of the Investing News Network and do not constitute investment advice. All readers are encouraged to perform their own due diligence.

Benzinga – Entheon Biomedical And Psygen Labs Inc.’s DMT Drug Supply Agreement

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This article was originally published on Microdose Psychedelic Insights and appears here with permission.

The mantra of the emerging psychedelic medicine industry ought to be collaboration over competition. It seems that almost every week, a new collaboration or partnership is announced. Today, Canadian biotechnology company Entheon Biomedical announced a DMT drug supply agreement with the Calgary-based psychedelic company Psygen Labs Inc. Psygen will supply Entheon with DMT for upcoming “formulation, preclinical, clinical, and post-approval commercialization phases.” Exact details on this agreement can be found in the press release below.

PsyGen Labs Chief Scientific Officer Peter Van der Heyden also spoke at our Mushrooms Conference in November – for the full story, click here.

Additionally, you can read our exclusive story on Entheon’s use of DMT-assisted psychotherapy for addiction treatment here.

About Entheon Biomedical Corp.


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Entheon is a biotechnology research and development company committed to developing and commercializing a portfolio of safe and effective N,N-dimethyltryptamine based psychedelic therapeutic products (“DMT Products“) for the purposes of treating addiction and substance use disorders. Subject to obtaining all requisite regulatory approvals and permits, Entheon intends to generate revenue through the sale of its DMT Products to physicians, clinics and licensed psychiatrists in the United States, certain countries in the European Union and throughout Canada.

About Psygen Labs Inc.

Psygen Labs Inc (“Psygen“) is a Calgary-based company specializing in the synthetic manufacture of psychedelic medicines. The company provides non-exclusive access to psychedelic drug substances and products for clinical research and therapeutic applications. Psygen is well positioned to be a lead supplier for the emerging commercial market. Psygen has sponsored a Licensed Dealer who holds a license for the manufacture, sale, import, export, and analysis of psilocybin, MDMA, DMT, LSD, 2C-B, and mescaline. Psygen’s chemists and manufacturing lab currently reside at the University of Alberta. Psygen has applied to Health Canada for a corporate Dealer’s License which will allow the company to manufacture, possess, sell, import, export, research, develop, and analyze psychedelic drug substances and products. Psygen is actively developing and constructing a 6000sq/ft lab capable of large-scale synthesis, formulation, and distribution of the above and additional psychedelics. Psygen intends to be the leader in psychedelic supply chain solutions and is committed to supporting the renaissance in research and clinical treatment of a wide variety of mental health issues.

Read the original Article on Microdose Psychedelic Insights.

INN: Psychedelic Trends 2020: The Heat is On

2020 marked the beginning of the psychedelics investment story as the capital markets fully embraced the alternative drug sector.

The idea of investing in a psychedelic drug company may have sounded unlikely before 2020.

But now investors are enjoying the dawn of a new alternative drug market that is trying to capitalize on the medical benefits of psychedelic substances.

In 2020, investors saw the arrival of a number of new public companies that are exploring various pathways in the psychedelics space, primarily operating under the promise of new medicine.

It’s no exaggeration to say that 2020 served as the launching pad for psychedelics in the eyes of the capital markets. And that included us, as here at the Investing News Network (INN) we launched our own psychedelics-focused vertical.

Read on to get a sense of the psychedelics trends that are setting the stage for this promising new industry, with commentary from insiders and experts.

Psychedelics trends 2020: Markets get their bets ready as listings erupt

As mentioned, this year catapulted a fresh stock universe into existence as a variety of new companies went public across different exchanges.

While it wasn’t the first of the year, the listing of Compass Pathways (NASDAQ:CMPS) was one of the biggest landmark events for the industry in 2020. The company was the first psychedelics operation to list directly on the NASDAQ, opening the door for others to follow.

“It’s shown to the world what insiders have known for a long time — that this vision of bringing psychedelic medicine to the world isn’t a pipe dream, it’s very real and it’s happening now,” Michael Hoyos, co-founding partner, Americas, with the Conscious Fund, previously told INN.

Fellow companies also celebrated Compass Pathways’ debut as the arrival of a new era.

“Compass’ successful IPO is further evidence that psychedelics are gaining traction as a viable solution for treating mental health and addiction,” JR Rahn, co-founder and co-CEO of Mind Medicine (MindMed) (NEO:MMED,OTCQB:MMEDF), said.

During an online talk in the leadup to the Compass Pathways listing, Bill Stern, managing partner at Venture Group Capital, said the listing looked set to “change the industry dramatically.”

Dugan Selkirk, media relations manager for Vancouver-based private firm Universal Ibogaine, was not elusive about the significance of the NASDAQ listing. “The top blew off with Compass Pathways’ mega IPO in the US markets, which has put the wind back into the sails of the industry, and we see this pattern continuing with momentum into 2021.”

Jos Schmitt, president and CEO of the NEO Exchange, told INN he believes investors have to get over any stigma surrounding these substances, because he believes the opportunity is too great to pass up.

Back in March, when MindMed went public, the NEO saw Canada’s first official listing of a company operating in the psychedelics space.

A fellow securities executive previously told INN he was unsure when he first heard about the psychedelics investment shot. “I will admit, I was a bit skeptical at first,” said Richard Carleton, CEO of the Canadian Securities Exchange (CSE).

Carleton changed his mind after seeing the research that has been conducted and meeting with companies directly to discuss the sector.

The CSE is now the capital markets home of nearly 30 listings related to the psychedelics industry.

Psychedelics trends 2020: Pandemic highlights need for mental health alternatives

Florian Brand, co-founder and CEO of privately held ATAI Life Sciences, told INN he came into 2020 expecting a natural progression of the interest in therapies using psychedelics. But instead the executive found a significant jump in attention, thanks in large part to the focus on mental health created by the effects of a global pandemic.

Brand said the uncertainty surrounding COVID-19 has “precipitated an increased focus on mental health and the failures of our current standards of care.”

Doug Drysdale, CEO of Cybin (NEO:CYBN), echoed Brand’s sentiment, saying he believes the pandemic accelerated the acceptance of using alternative methods to treat mental health issues.

“We are seeing a paradigm shift in the public view and complacency for the norm of Big Pharma traditional, (and) in many cases dangerous and non-effective, treatments,” Josh Bartch, CEO of Mydecine Innovations Group (CSE:MYCO), told INN.

Psychedelics trends 2020: Executives ask for patience in face of growing buzz

As the psychedelics industry first started to develop, it became clear that one of the most direct points of comparison would be with the cannabis industry.

“Had cannabis not come along, it probably would have been a longer road to be having some of these conversations,” Ronan Levy, co-founder and executive chairman of Field Trip Health (CSE:FTRP), previously told INN.

To a degree it’s understandable, as both are alternative drug markets exploring new uses in the face of strict regulations. But some members of the psychedelics industry have been quick to deter investors from believing psychedelics will see similar hype runs to those experienced in the cannabis industry.

This leaves the question of if investors should play the market or get ready for long-term bets only.

Payton Nyquvest, chairman and CEO of Numinus Wellness (TSXV:NUMI), previously told INN that anyone entering this space has to understand the long-term roadmap ahead. “There’s no quick pathway to be able to do this,” he said.

Brand said it’s the responsibility of psychedelics companies to fully research these compounds and learn their entire medical benefits, as well as the potential risks attached.

“Viewing psychedelics as a panacea is alluring, but in reality there’s risks we still need to quantify,” said Brand of ATAI Life Sciences. “It’s incumbent on us and others in the space to build out the data and support for safe and accessible treatment, and not let excitement get ahead of the hard work to build a sustainable, impactful industry.”

Drysdale told INN that in his view the most challenging aspect for the psychedelics market in 2020 was the pressure to gain credibility and attention due to the rush of companies going public.

“Psychedelics are leading with science, creating massive intellectual property (IP) opportunities, and both of these things rely on regulation holding the industry to standards and pace,” Kelsey Ramsden, president and CEO Mind Cure Health (CSE:MCUR,OTCQB:MCURF), told INN. “As a company who is in high-growth mode with fast-moving IP projects, being patient can be challenging.”

That sentiment of longevity for investments was echoed by Carleton, who said he sees the psychedelics market as a “pharma play.”

Hoyos told INN the industry needs to be careful to not repeat the mistakes made in the cannabis space, which led to a large part of the sector wanting to make a quick buck compared to growing steadily.

“For investing in the space, I think the full value will be realized in the longer term, but there will be opportunities for exit liquidity events a lot sooner,” Hoyos added.

Psychedelics trends 2020: Studies set path for changing perspectives

One of the biggest factors helping psychedelics is the launch and continuation of medical studies evaluating particular drug treatments based on psychedelics and boosting the legitimacy of the industry.

Timothy Ko, CEO at Entheon Biomedical (CSE:ENBI), told INN that 2020 will be remembered as a year in which the psychedelics industry established itself and came into the spotlight thanks to the work of those “who have historically utilized, researched and spoken for the value of psychedelic compounds.”

Investors will need to keep an eye on the development of several studies moving forward, as these will offer the most concrete answers on whose drugs are worth betting on. These studies, particularly those to obtain approval from the US Food and Drug Administration, are extremely lengthy and costly events for the companies in play.

“I think the challenge and gift of regulation resting in the balance of scientific proof is what will both make this a stable and rapidly growing investment sector,” Ramsden said.

Thanks to recognition from medical authorities, more investors are starting to look into what’s at stake with psychedelics.

Psychedelics trends 2020: Investor takeaway

The psychedelics industry found its groove in 2020 and discovered investors ready to listen and get involved. This growth in attention may be partially due to the effects of lockdowns and the uncertainty caused by COVID-19, but it is also backed by the medical research being conducted.

In 2020, investors discovered the enthusiasm for psychedelics goes well beyond college dorm rooms.

Don’t forget to follow us @INN_LifeScience for real-time news updates!

Securities Disclosure: I, Bryan Mc Govern, hold no direct investment interest in any company mentioned in this article.

Editorial Disclosure: Cybin, Mind Cure Health, Numinus Wellness and Universal Ibogaine are clients of the Investing News Network. This article is not paid-for content.

The Investing News Network does not guarantee the accuracy or thoroughness of the information reported in the interviews it conducts. The opinions expressed in these interviews do not reflect the opinions of the Investing News Network and do not constitute investment advice. All readers are encouraged to perform their own due diligence.

Benzinga – Psyched: Canada Allows Psilocybin Use For Healthcare Pros, UK Begins DMT Trials, Cybin To Purchase Adelia

Psyched: Canada Allows Psilocybin Use For Healthcare Pros, UK Begins DMT Trials, Cybin To Purchase Adelia

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Canada Allows Professionals In Training To Use Psilocybin

The Canadian Health Minister Patty Hajdu has allowed 17 healthcare professionals to possess and use psilocybin to conduct professional training in psilocybin-assisted therapy.

The decision, announced Tuesday, marks the latest step in Canada’s path towards the legalization of psilocybin.

Since August 2020, Canada’s Health Minister has granted 14 exemptions to access psilocybin therapy, mainly for patients dealing with end-of-life distress.


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“Health Canada now rightfully acknowledges that clinician experience with psychedelic medicines is an important part of their training. Therapists having psychedelic experience are able to more deeply empathize with patients and understand their experience,” said Bruce Tobin, founder and Board Chair of TheraPsil, a nonprofit working for patient access to psilocybin in Canada.

The UK To Begin First-Ever Clinical Trials On DMT For Depression

The Imperial College of London, in partnership with neuropharmaceutical research company Small Pharma, have been granted approval from UK authorities to begin clinical trials on the hallucinogenic drug DMT for the treatment of depression.

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) gave the green light to begin the trials, which are expected to start in January 2021, The Guardian reported.

The trials will mark the first time that DMT is studied in the treatment of clinical depression. The institutions stated that the essays will be based on recent clinical research on psilocybin.

In its initial phase, 32 healthy volunteers will be given DMT in order to understand the minimum dose needed to achieve a psychedelic effect. After that, the drug will be administered to 36 separate patients, who have been diagnosed with clinical depression.

The parties still await Home Office approval given the scheduled condition of the drug. DMT remains illegal in the UK as in most countries around the globe.

Cybin to Acquire Adelia Therapeutics for $15.7M

This week, Canadian psychedelics company Cybin (NEO: CYBN) signed a definitive agreement to acquire 100% Adelia Therapeutics, a biopharmaceutical company focused on the development of proprietary psychedelic derivatives.

The purchase was done through an all-stock transaction of CA$20.1 million (approximately $15.7 million).

“Adelia’s focus on creating novel therapeutics, including novel delivery methods and innovative therapeutic regimens can support our goal of creating therapies that result in faster onset of action, smoother pharmacokinetic profiles, shorter treatment durations, and reduced side effects,” said Cybin CEO Doug Drysdale.

With the purchase, which is part of Cybin’s expansion strategy through M&A, the company expects to develop a novel drug discovery platform with efficient drug delivery aimed at enhancing dosing control and developing a potential novel treatment regimen.

This Week’s Milestone Round

The Usona Institute, a Wisconsin-based nonprofit focused on psychedelics research published a new method of synthesis for 5-MeO-DMT, a psychedelic compound closely related to DMT, which is naturally produced by the Sonoran Desert toad.

The novel method emphasizes scalability, controllability, and reproducibility in order to support production of the compound for clinical research. According to Usona, previous synthetic routes did not achieve these goals.

Field Trip Health (CSE:FTRP) (OTCQB:FTRPF) announced a new private offering of CA$15 million ($11.7 million) to close on or about January 5, 2021. The company is offering 3,333,333 units (comprising one share and one-half of a common share purchase warrant) at a price of CA$4.50 per Unit. On Friday December 11, Field Trip stock closed at CA$5.60.

MindMed (NEO: MMED) (OTCQB:MMEDF) announced the closing of its last offering, for gross proceeds of CA$34.5 million ($27 million).

More companies are also looking at clinical research on DMT. On Wednesday, Entheon Biomedical (CSE:ENBI), a Canadian company focused on studying DMT’s medicinal potential, announced closing a drug-supply agreement with Psygen Labs Inc.

Entheon will receive DMT for future formulation, preclinical and clinical research, aimed at  post-approval commercialization of the drug. The company expects to start clinical trials on DMT by late 2021, in association with the Centre for Human Drug Research in the Netherlands.

Biotech company BetterLife Pharma (CSE:BETR) (OTCQB:BETRF), is entering the psychedelics space with the signage of an agreement to acquire Transcend Biodynamics, in an all-stock transaction of CA$10 million ($7.8 million).

Transcend is researching BOL-148, a derivative of LSD that is touted to offer several of the same therapeutic actions -like treating cluster headaches- without the psychedelic effect.

Benzinga – Imperial College Of London To Study Illegal Psychedelic Compound In First-Ever Clinical Trial

Clinical trials on the hallucinogenic drug DMT for the treatment of depression are expected to start in January.

According to The Guardian, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) gave the green light to the Imperial College of London, in partnership with neuropharmaceutical research company Small Pharma, to begin the trials.

DMT, a strong, short-acting hallucinogenic compound, remains illegal in the UK as in most countries around the globe. It is best known as the active ingredient in ayahuasca, a hallucinogenic drink traditionally used as a spiritual medicine in shamanic ceremonies among indigenous communities in South America.

Studying DMT for Depression

This would be the first time DMT is studied in the treatment of clinical depression.


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The institutions stated that the essays will be based on recent clinical research on psilocybin, the active psychedelic compound in magic mushrooms.

In its initial phase, 32 healthy volunteers will be given DMT in order to understand the minimum dose needed to achieve a psychedelic effect. After that, the drug will be administered to 36 separate patients, who have been diagnosed with clinical depression.

The parties still await Home Office approval given the scheduled condition of the drug.

DMT vs Psilocybin: Small Pharma CEO Peter Rands said that DMT’s intense, short-acting psychedelic effect could become a viable alternative to psilocybin treatment in cases where patients cannot participate in the long sessions required by the latter.

A typical psilocybin “trip” will last between two to four hours. In a medical setting, that’s accompanied by four more hours of psychotherapy in order to integrate the experience into the patient’s life.

DMT typically has an onset and offset time of just 15 to 30 minutes, allowing for faster sessions within the long-term treatment.

More Research Is On Its Way: Earlier this year, New York-based MindMed (MEO: MMED) (OTCQB:MMEDF) announced it will begin studying DMT’s correct dosing and duration in a Phase 1 clinical trial conducted in collaboration with University Hospital Basel in Switzerland.

More companies are also looking at clinical research on DMT.

On Wednesday, Entheon Biomedical (CSE:ENBI), a Canadian company focused on studying DMT’s medicinal potential, closed a drug-supply agreement with Psygen Labs Inc.
Entheon will receive DMT for future formulation, preclinical and clinical research, aimed at  receiving post-approval commercialization of the drug. The company expects to start clinical trials on DMT by late 2021, in association with the Centre for Human Drug Research in the Netherlands.

Photo by cottonbro from Pexels.

Entheon Biomedical Announces Corporate Update Including Investment in Wonder Scientific

Originally published at https://www.newsfilecorp.com/release/69518

Vancouver, BC – December 4, 2020 – Entheon Biomedical Corp. (CSE: “ENBI”) (FSE:1XU1) (“Entheon” or the “Company”), a biotechnology company focused on developing psychedelic medicines to treat addiction, announces a strategic investment in Wonder Scientific Inc. (“Wonder Scientific”).

Wonder Scientific’s team of University Researchers and Product Development experts create custom, naturally derived, active pharmaceutical ingredients (APIs) to supply the growing global clinical and commercial demand for psychedelics.

Entheon’s first strategic investment provides exposure in other verticals of the psychedelic therapy space and strategic access to psychoactive pharmaceutical ingredients and scientific bench strength as Entheon develops therapeutic treatments for addiction.

“Our investment in Wonder Scientific is part of our strategy in gaining low risk exposure to other segments of the regulated psychedelic treatment space,” said Timothy Ko. “Their team of experienced pharmacologists and product experts enhances a strategic relationship providing opportunities for additional revenues from the company’s line of genetics, bio-stimulants, and pharmaceuticals.

Tegan Adams, President & Founder of Wonder Scientific, commented on the partnership: We are absolutely thrilled and privileged to have our value and strategy highlighted and recognized by Entheon management. We look forward to upcoming collaborations and a profitable symbiotic relationship.”

 

Entheon is pleased to announce it has entered into an investor relations consulting agreement with Mr. Joseph Cullen.

Mr. Cullen’s career has included over five years of public market experience primarily focused on the resource and technology sectors with an emphasis on investor relations and corporate finance. His previous experience also includes working for Deloitte and VMWare, as well as co-founding and managing private ventures in the financial services, environmental consultancy, and technology sectors. Mr. Cullen is being paid $5000 per month for a one year term.

Further, pursuant to its stock option plan, the Company has granted option to purchase up to 3,175,000 common shares in the Company (the “Options”) to certain officers, directors and consultants of the Company. The Options are exercisable at $0.71 per share for a period of five years from the date of grant. Of the Options, 2,725,000 are subject to vesting over a 2-year term. The Options have been granted under and are governed by the terms of the Company’s incentive stock option plan.

About Entheon Biomedical Corp.

Entheon is a biotechnology research and development company committed to developing and commercializing a portfolio of safe and effective N,N-dimethyltryptamine based psychedelic therapeutic products (“DMT Products”) for the purposes of treating addiction and substance use disorders. Subject to obtaining all requisite regulatory approvals and permits, Entheon intends to generate revenue through the sale of its DMT Products to physicians, clinics and licensed psychiatrists in the United States, certain countries in the European Union and throughout Canada.

About Wonder Scientific

Wonder’s vision is to help the world find it’s Wonder again. Wonder’s mission is to unlock the healing properties of hundreds of new plant medicines sourced from diverse locations, transforming them into regulated pharmaceutical products for global commercialization and sales.

For more information, please contact the Company at:

Entheon Biomedical Corp.
Joseph Cullen
Telephone: +1 (778) 919-8615
joe@entheonbiomedical.com
https://entheonbiomedical.com/

For media inquiries, please contact Crystal Quast at:

Bullseye Corporate
Crystal Quast
Telephone: +1 (647) 529-6364
Quast@BullseyeCorporate.com

 

Cautionary Note on Forward Looking Information

This news release contains forward‐looking statements and forward‐looking information within the meaning of applicable securities laws. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward‐looking statements or information. More particularly and without limitation, this news release contains forward‐looking statements and information relating to a strategic investment, the performance of such investment and other matters. The forward‐looking statements and information are based on certain key expectations and assumptions made by management of the Company. Although management of the Company believes that the expectations and assumptions on which such forward-looking statements and information are based are reasonable, undue reliance should not be placed on the forward‐looking statements and information since no assurance can be given that they will prove to be correct. Forward-looking statements and information are provided for the purpose of providing information about the current expectations and plans of management of the Company relating to the future. Readers are cautioned that reliance on such statements and information may not be appropriate for other purposes, such as making investment decisions. Since forward‐looking statements and information 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. These include, but are not limited to, the Company’s ability to raise further capital and the Company’s ability to obtain regulatory and exchange approvals. Accordingly, readers should not place undue reliance on the forward‐looking statements and information contained in this news release. Readers are cautioned that the foregoing list of factors is not exhaustive. The forward‐looking statements and information contained in this news release are made as of the date hereof and no undertaking is given to update publicly or revise any forward‐looking statements or information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws. The forward-looking statements or information contained in this news release are expressly qualified by this cautionary statement. Neither the CSE nor the Investment Industry Regulatory Organization of Canada accepts responsibility for the adequacy or accuracy of this release.

Entheon Biomedical Announces CRO Agreement with CHDR for Phase 1 Clinical Trial

Centre for Human Drug Research led DMT study to start in 2021

Vancouver, BC – December 1, 2020 – Entheon Biomedical Corp. (“Entheon” or the “Company”) (CSE: ENBI(FSE: 1XU1), a biotechnology company focused on developing psychedelic medicines to treat addiction, announced it has entered into a Clinical Study Agreement with the Contract Research Organization (CRO) Centre for Human Drug Research (CHDR) to conduct an early phase human clinical trial with DMT.

CHDR is a Leiden, Netherlands-based contract research organization (CRO) that specializes in early-stage clinical drug research. Based on an agreement signed October 7th, 2020, Entheon has contracted CHDR to carry out a study to evaluate the pharmacodynamics, pharmacokinetics and safety of a target-controlled intravenous infusion of N,N-dimethyltryptamine (DMT) (the “Product”) in humans.

CHDR research director of psychiatry, Gabiel Jacobs stated, “The CHDR psychiatry team is looking forward to the exciting collaboration with Entheon in conducting this data-intensive study with DMT in humans. Characterization of both its functional central nervous system effects and its impact on subjective experience, and to relate these to its pharmacokinetics, is crucial to properly understand DMT’s potential as pharmacotherapeutic.”

“This is a significant milestone in our mission to develop therapeutic protocols to treat substance use disorders. We believe that the CHDR’s renowned expertise in conducting early-stage clinicals trials and their use of innovative technology makes them an excellent CRO to partner with,” said Timothy Ko, Chief Executive Officer of Entheon. “With the CHDR’s partner pharmacy having successfully received an amendment to its opiate license to include DMT and having applied for its import permit for DMT, we are advancing on steps for our clinical trial, which is expected to start in the late summer of 2021.”

About the Centre for Human Drug Research (CHDR)

The Centre for Human Drug Research (CHDR) is an independent institute that specializes in cutting-edge early-stage clinical drug research. Combining innovative methods and technologies, state-of-the-art facilities, and talented, motivated researchers helps CHDR maximize their clients’ success. In addition, CHDR places the highest priority on their subjects’ comfort and safety, and they play an active role in helping educate the medical and clinical research communities. In addition, CHDR utilizes the services of the GMP-compliant the Leiden University Medical Center (LUMC). The LUMC pharmacy prepares and delivers the pharmaceutical products, including investigational medicinal products, and offers tailor-made solutions to help answer our sponsors’ questions.

About Entheon Biomedical Corp.

Entheon is a biotechnology research and development company committed to developing and commercializing a portfolio of safe and effective N,N-dimethyltryptamine based psychedelic therapeutic products (“DMT Products”) for the purposes of treating addiction and substance use disorders. Subject to obtaining all requisite regulatory approvals and permits, Entheon intends to generate revenue through the sale of its DMT Products to physicians, clinics and licensed psychiatrists in the United States, certain countries in the European Union and throughout Canada.

For more information, please contact the Company at:

Entheon Biomedical Corp.
Timothy Ko
Telephone: +1 (604) 562-3932
info@entheonbiomedical.com
https://entheonbiomedical.com/

For media inquiries, please contact Crystal Quast at:

Bullseye Corporate
Crystal Quast
Telephone: +1 (647) 529-6364
Quast@BullseyeCorporate.com

Website Twitter Facebook LinkedIn

 

Cautionary Note on Forward Looking Information

This news release contains forward‐looking statements and forward‐looking information within the meaning of applicable securities laws. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward‐looking statements or information. More particularly and without limitation, this news release contains forward‐looking statements and information relating to the approval of the proposed study protocol by the Dutch Medical Ethics Review Committee, the commencement of the study, the ability to obtain study participants, the results and outcomes of the study, and other matters. The forward‐looking statements and information are based on certain key expectations and assumptions made by management of the Company. Although management of the Company believes that the expectations and assumptions on which such forward-looking statements and information are based are reasonable, undue reliance should not be placed on the forward‐looking statements and information since no assurance can be given that they will prove to be correct. Forward-looking statements and information are provided for the purpose of providing information about the current expectations and plans of management of the Company relating to the future. Readers are cautioned that reliance on such statements and information may not be appropriate for other purposes, such as making investment decisions. Since forward‐looking statements and information 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. These include, but are not limited to, the Company’s ability to raise further capital and the Company’s ability to obtain regulatory and exchange approvals. Accordingly, readers should not place undue reliance on the forward‐looking statements and information contained in this news release. Readers are cautioned that the foregoing list of factors is not exhaustive. The forward‐looking statements and information contained in this news release are made as of the date hereof and no undertaking is given to update publicly or revise any forward‐looking statements or information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws. The forward-looking statements or information contained in this news release are expressly qualified by this cautionary statement. Neither the CSE nor the Investment Industry Regulatory Organization of Canada accepts responsibility for the adequacy or accuracy of this release.