Psychedelics Archives - Green Market Report

Debra BorchardtJanuary 21, 2022
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Silver Spike Acquisition Corp. II (NASDAQ: SPKB/SPKBU/SPKBW), a publicly-traded special purpose acquisition company or SPAC sponsored by an affiliate of Silver Spike Capital announced on Thursday that it has signed an agreement expected to make Eleusis a public company. Eleusis is a clinical-stage life science company that aims to unlock the therapeutic potential of psychedelics. The combined company will be operated through Eleusis Inc., a new holding company, and will apply to have its common stock listed on Nasdaq under the symbol “ELEU.” Eleusis said it expects to use the proceeds received from SPKB’s trust account in the transaction to support clinical development of ELE-Psilo, early stage drug discovery and translational research, and the nationwide expansion of Andala-managed clinics.

“This is an ideal moment for Eleusis to go public with a partner like Silver Spike,” said Shlomi Raz, CEO and founder of Eleusis. “We are thrilled to work with the Silver Spike team, whose extensive financial and industry experience complement our expertise. We believe access to public capital markets will accelerate our efforts to transform psychedelics into modern medicines, and ultimately offers the potential to improve millions of patients’ lives while creating long-term value for our shareholders.”

Eleusis was founded in 2013 and is dedicated to transforming psychedelics into medicines. ELE-Psilo, Eleusis’s lead drug candidate, is being developed to treat depression and is expected to enter Phase I trials in 2022, subject to regulatory authorization. Eleusis designed ELE-Psilo, if FDA-approved, to be compatible with existing U.S. healthcare infrastructure and insurance coverage and reimbursement requirements. Eleusis formulated ELE-Psilo to deliver psilocin, the active ingredient in psilocybin, via IV infusion. IV-administered psilocin has the potential to offer more consistent therapeutic effects to patients, more controllable therapies to clinicians, and shorter treatment times – planned to be two hours or less – than orally-administered psilocybin exhibited in third-party clinical studies.

Scott Gordon, CEO and Chairman of SPKB, and CEO and Founder of Silver Spike, added, “At Silver Spike, we believe that realizing the vast therapeutic potential of psychedelics will require companies like Eleusis to develop practical solutions to accelerate mainstream adoption and spur innovation that leads to approved psychedelic therapies that are both accessible and affordable. In addition, Andala’s groundbreaking work managing clinics to address the ‘last mile’ challenge of psychedelics is consistent with our investment thesis in alternative health and wellness categories – find the companies that enable an entire market to scale. We believe Eleusis has identified the ‘end game’ of developing psychedelic drug therapies, and we are excited to be playing a role in potentially realizing its inspiring vision.”

Silver Spike Acquisition Corp. II is a $287.5 million SPAC sponsored by Silver Spike, an asset manager with deep expertise in health, wellness, and cannabis investments. The team’s experience includes the completed merger of Silver Spike’s first SPAC, Silver Spike Acquisition Corp., with WM Holding Company better known as WeedMaps.


Dave HodesJanuary 20, 2022
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It wasn’t that long ago when psychedelics emerged as a potentially better natural plant-based medicine for treating such things as treatment-resistant depression (TRD), into what is now a billion-dollar juggernaut of an industry. 

Then an even curiouser thing happened. Around 2015, organizers of more and more conferences about cannabis—and some that were not about cannabis at all—began inviting psychedelic speakers or otherwise acknowledging their contribution to new medical therapeutic discoveries. People were curious. Intrigued. Wanted psychedelics leaders to join in the discussions.

Consider:

– On January 23 at the 2019 World Economic Forum, psychedelics were featured in a panel with the eminent Robert Carhart-Harris, head of the Centre for Psychedelic Research, Division of Brain Sciences, Faculty of Medicine, Imperial College London. He spoke about “The New Science of Psychedelics.”

– Psychedelics discussions have found their way into TedX talks since 2016—reportedly 11 such talks as of July 2021.

– The 2019 SXSW show featured a session on psychedelics with Michael Pollan, “Exploring the Frontiers of Psychedelics,” and a meetup about psychedelics. Now there are six psychedelics sessions planned as part of a two-day summit at the 2022 SXSW. One of which our Executive Editor Debra Borchardt is moderating titled “The Psychedelic Investment Opportunity.” Joining her are  Ronan Levy, founder of Field Trip Health (NASDAQ: FTRP), Daniel Goldberg of Palo Santo VC Fund, and Gregg Peterson of Bexson Biomedical.

– The three-day May, 2022 Cannabis Science and Technology conference added a whole conference track on psychedelics, with 11 sessions.

– The international annual BioHacker Summit featuring world experts on human well-being, performance and health, held each year since 2016 examining such issues as building a personal life extension strategy and how to biohack yourself to optimal wellness, featured Robin Carhart-Harris in 2018 for their first session on psychedelics.

– Psychedelics even had a presence at one of the world’s largest trade shows, the 2022 Consumer Electronics Show, which gave Tripp PsyAssist the CES 2022 Innovation Award for their virtual reality tool that can be used in psychedelics therapy.

Business investors are more interested in the industry than ever before. They want more. And business conferences are giving it to them.

One of those investor conferences is Microdose Media’s Psychedelic Capital, held nearly every month since June 2020, which covers the top companies, latest IPOs, opportunities, and insights into the psychedelic industry. Microdose held one of the largest worldwide virtual conferences for the emerging psychedelic medicine industry in April 2020.

In January 2021, a high-level business investor discussion on psychedelics, “A New Era for Psychedelic Medicine,” was one of the science talks sponsored by SALT, a New York venture group that organizes global thought leadership and networking forums moderated by SALT Chairman Anthony Scaramucci. SALT talks have featured such notables as Presidents George Bush and Bill Clinton, movie stars, ambassadors, prime ministers, innovative business developers, and more. Movers and shakers pay attention to any topic discussed here.

There is a growing host of conferences both large and small dedicated to the psychedelics business, such as the annual Interdisciplinary Conference on Psychedelic Research; the Cannadelic Miami conference on February 5 and 6 in Miami, billed as the first cannabis and psychedelics event; and another big psychedelics conference planned for 2023—Psychedelic Science, June 19-23 in Denver, Colorado. 

Adding to the public meeting and conference movement, mention of psychedelics continues in the pages of such well-respected national and international publications such as The Economist, Forbes, Wall Street Journal, The NY Times and other respected business and lifestyle publications, some of whom can’t help from including tongue-in-cheek headlines (The Economist: “Investors hope psychedelics are the new cannabis. Are they high?”) just to demonstrate they are still somewhat skeptical.


Dave HodesJanuary 19, 2022
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The year 2021 has not been kind to the psychedelics industry. The stock performances of the 60 publicly traded psychedelics companies on the Psychedelic Stock Index have been trending steadily downward since February 22, 2021, to their lowest point since the index began on June 1, 2020.

The pandemic has definitely affected psychedelic business development. Nevertheless, a few companies are getting closer to offering products and expanding therapy services. So a looming perfect storm of more psychedelic companies laying the groundwork for further development may encourage a business rebound in 2022.

Here are our picks for the five psychedelic companies to watch in 2022:

Atai Life Sciences, Berlin, Germany – listed on NASDAQ (ATAI) since July, 2021 – Market cap $999 million

Atai Life Sciences, a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, is also one of the largest shareholders in Compass Pathways. In December, 2021, Atai Impact, launched in October, 2021 as the philanthropic program of Atai Life Sciences, announced its first major initiative, the establishment of the Atai $2 million Fellowship Fund in Psychedelic Neuroscience in collaboration with Massachusetts General Hospital’s Center for the Neuroscience of Psychedelics. The company also entered into a series of joint ventures and acquisitions in 2021, including with Psyber, a globally based startup focused on the development of brain-computer interface-enabled digital therapeutics for treating mental health issues. What’s coming in 2022: In January, 2022, the U.S. Food and Drug Administration (FDA) gave Atai Investigational New Drug (IND) clearance to conduct a clinical study of ketamine. Atai plans to initiate the study early this year through its platform company Perception Neuroscience.

Compass Pathways, London, England – listed on NASDAQ (CMPS) since September 2020 – Market cap $751 million

Compass Pathways is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Compass has completed a phase IIb clinical trial of psilocybin therapy for treatment resistant depression in 22 sites across Europe and North America, one of the largest randomized, controlled, double-blind psilocybin therapy clinical trial ever conducted. Compass is also running a phase II clinical trial of COMP360 psilocybin therapy for post-traumatic stress disorder (PTSD).  What’s coming in 2022: The company is preparing for a meeting with the FDA in early 2022 to finalize a program using their psilocybin therapy, and anticipates commencing that program late in 2022.

 

Cybin, Toronto, Ontario, CNlisted on NYSE (CYBN) since August 2021 – Market cap $192 million

Cybin is a leading biotechnology company focused on progressing psychedelic therapeutics by utilizing proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for psychiatric disorders. It was the first psychedelics company to trade on the NYSE in August, 2021. The company has raised just over $96 million to date to fund clinical trials, M&A and IP strategies. What’s coming in 2022: In October 26, 2021, the FDA authorized an IND application to proceed with the company’s sponsored feasibility study using Kernel’s Flow technology to measure ketamine’s psychedelic effect on cerebral cortex hemodynamics (brain flow blood). Kernel Flow uses pulsed light instead of continuous wave light to increase measured brain information. Kernel Flow is a wearable device the size and look of a bicycle helmet. In the future, it could be more broadly used for neuroscientific or physiological studies of brain activity during psychedelic use.

 

Field Trip Health, Toronto, CN – listed on NASDAQ (FTRP) since July 2021 – Market cap $149 million

Field Trip does research and development on novel, psychedelic-inspired regulated medicines, and operates clinics that deliver ketamine-assisted psychotherapy in Canada and the United States. Field Trip currently operates and/or owns nine clinics in Toronto, Ontario; Fredericton, 

New Brunswick; New York, New York; Santa Monica, California; Chicago, Illinois; Atlanta, Georgia; Seattle, Washington; Houston, Texas; and Amsterdam, The Netherlands. What’s coming in 2022: The company is planning to build an additional nine Field Trip Health Centers in Vancouver, British Columbia; San Diego, California; Washington, DC; Stamford, Connecticut; San Carlos, California; Austin, Texas; Scottsdale, Arizona; Dallas, Texas; and Miami, Florida. On January, 2022, Field Trip announced that the U.S. Patent and Trademark Office (USPTO) issued a Notice of Allowance for Field Trip’s patent application for their first novel psychedelic molecule in development. Field Trip expects the patent to be issued in February, 2022.

 

MindMed, New York, NY – listed on NASDAQ (MNMD) since April 2021. Market cap $357 million.

MindMed is a clinical-stage biotech company that seeks to discover, develop and deploy psychedelic-inspired medicines and therapies to address mental health and addiction. What’s coming in 2022: On January 4, 2022, the company announced the completion of its Phase 1 clinical trial of 18-MC, the company’s non-hallucinogenic proprietary derivative of ibogaine, being developed for the treatment of indications linked to opioid use disorder. This phase 1 single and multiple ascending dose trial conducted at a single clinical research site in Perth, Australia, evaluated the safety, tolerability, pharmacokinetics, and effects on the cognitive activity of 18-MC in healthy volunteers. The trial was completed in December 2021 with results expected in early 2022.

Sources: Company SEC filings; Yahoo! Finance; Psychedelic Stock Index; company websites and press releases


Dave HodesJanuary 18, 2022
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“Omicron, with its extraordinary, unprecedented degree of efficiency of transmissibility, will, ultimately, find just about everybody,” Dr. Anthony Fauci, President Joe Biden’s chief medical advisor, told moderator J. Stephen Morrison during a “fireside chat” January 11 at the Center for Strategic International Studies. “Those who have been vaccinated and vaccinated and boosted would get exposed. Some, maybe a lot of them, will get infected but will very likely, with some exceptions, do reasonably well in the sense of not having hospitalization and death.”

So, that’s the new virus normal—it’s inevitable that Covid, in its current variant or in another variant yet to be discovered, will infect most of us, and will be with us for years to come.

Now what?

Two federally illegal classes of substances may play a role in dealing with Covid going forward. One substance works mostly on the body, one works mostly on the mind.

For example, there is a study by researchers at Oregon State University published in the Journal of Natural Products in October showing that cannabinoids “isolated or in hemp extracts, have the potential to prevent as well as treat infection by SARS-CoV-2 (Covid).” Cannabis may be able to block emerging variants, the study found.

That’s great news. But medical science is also turning to the other federally illegal class of substances that could just be the magic bullet for treating mental health issues such as depression, anxiety, even PTSD related to the Covid pandemic: psychedelics.

Covid and mental health

The CDC reported in mid-2020 that the coronavirus pandemic was associated with mental health challenges, including symptoms of anxiety disorder and depressive disorder that increased considerably in the United States during April through June of 2020. 

In CDC panel surveys conducted among adults 18 years and older in the U.S., 40.9% of respondents reported at least one adverse mental or behavioral health condition, including symptoms of anxiety disorder or depressive disorder (30.9%), symptoms of trauma- and stress or related disorder related to the pandemic (26.3%), and have started or increased substance use to cope with stress or emotions related to Covid (13.3%). 

The CDC survey also found that symptoms of anxiety disorder were approximately three times higher in the second quarter of 2019 (25.5% versus 8.1%), and the prevalence of depressive disorder was approximately four times that reported in the second quarter of 2019 (24.3% versus 6.5%).

And then there’s this: Patients with a recent diagnosis of a mental disorder had a significantly increased risk for Covid infection, according to a research report in the journal of the World Psychiatric Association.

Psychedelics to the rescue

A study in November 2021 from the Berlin Institute of Health looked into the effect of psychedelics used during the pandemic, including the settings in which people use psychedelics, the motives of usage, and the subjective quality of psychedelic experiences. The study found that the top three reasons why participants chose to use psychedelic substances in the last 4 weeks during the pandemic were (1) pleasure (2) self-awareness (3) spiritual or personal development.

Participants were asked to rate settings and motives of psychedelic substance use before the pandemic, and in the last 4 weeks during the pandemic, as well as changes in psychedelic experiences. 

Participants reportedly took one kind of a variety of psychedelics, that included either LSD, psilocybin, ayahuasca, mescaline, or DMT (LSD and psilocybin were most common).

During the pandemic, participants used psychedelics significantly less often in settings that were outside their homes. Participants consumed psychedelics less out of curiosity, to celebrate, or because friends took it, and more out of boredom.

Two-thirds of participants who used psychedelics during the pandemic claimed that psychedelics had helped them to deal better with the pandemic at least slightly. “To our surprise.. most participants did not report an increase in challenging psychedelic experiences when compared to the time before the pandemic,” study researchers concluded. “On the contrary, an increase in feelings of love and compassion for themselves, feelings of love and compassion for others, feelings of connectedness with nature, feelings of solidarity with people around them, and deep insights about the world during psychedelic experiences, were reported by up to one-third of participants, along with an increase in ego dissolution, pleasant feelings in the days after ingestion (“afterglow”), spiritual experiences, and visual effects.”

A deeper dive

Could psychedelics really be a mental health “cure-all” during a global pandemic that was—and still is—killing thousands of people each day? Johns Hopkins Medicine researchers discovered that two doses of psilocybin, given with supportive psychotherapy, produced rapid and large reductions in just the sort of depression symptoms many people were feeling from dealing with the pandemic for almost two years now. 

That work has served to inspire a small study at the University of Washington School of Medicine about whether psilocybin-assisted psychotherapy can help alleviate symptoms of depression and anxiety that front-line clinicians developed during the COVID-19 pandemic. 

For the study, all participants will have two 90-minute counseling sessions to build trust with therapists and to learn what to expect during the psychedelic experience. On the third visit, test-cohort participants will receive a dose of synthesized, pure psilocybin, equivalent to about 3 grams of dried mushrooms. That session will be guided by two therapists and is expected to last four hours or more. 

Dr. Anthony Back, the lead investigator on the study, suggested that psilocybin uniquely enables psychological exploration. “It makes your brain more plastic and your beliefs and desires less rigid,” he said. “It can allow people to break up habitual cycles of thoughts and beliefs that might cause their sadness and depression.”

The Usona Institute is providing the psilocybin for the trial, and Cybin is funding the training for clinicians who will be using Embark, Cybin’s model of psychedelic-assisted therapy.

It appears that psychedelics research is accelerating because of Covid, fueling the psychedelics renaissance that may make psychedelics a more credible, and more convincing, therapeutic solution for various mental health issues.

According to an article in the Irish Journal of Psychological Medicine, while at a relatively early stage of clinical development, “psilocybin therapy has the potential to play an important therapeutic role for various psychiatric disorders in post-Covid clinical psychiatry.”


Dave HodesJanuary 14, 2022
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The rush to business maturity for the psychedelics industry has led to inevitable comparisons to the growth and development of the cannabis industry. Both have captured the interest of angel investors channeling millions of dollars into them. There are currently 60 publicly traded psychedelic stocks now. 

Both have had complicated back stories within human cultural development that continue to this day, with racial issues connected to cannabis users since the late 1930s by the first director of the Federal Bureau of Narcotics, and hippie counter-culture wrong turns initiated by a Harvard professor for psychedelics in the 1960s still on the minds of naysayers.

Both are substances caught up in the war on drugs, listed as the worst drugs on the planet by the Drug Enforcement Administration (DEA).

But after their rocky start in the 60s, and a period of reflection about the good that psychedelics can really do, psychedelics today has bypassed the sort of negative stoner-boy druggy drop-out stereotype that dogs the cannabis industry, mostly because of the amount and depth of the science and research that has been brought to bear on psychedelics. 

Most forms of psychedelics—from Ecstacy (MDMA) to LSD to psilocybin and others—have been found to be helpful in some way to the mental well-being of humans if used in control settings. 

They are not total cures to such things as depression and some of the more difficult human mental conditions. But ongoing, and accelerating, clinical research in such esteemed institutions as Johns Hopkins Medicine has shown that they can at least provide people with a better quality of life. 

Psychedelic companies are building partnerships with academia, such as MindMed’s microdosing work treating addiction or adult ADHD with experiential therapies, and redefining what psychedelics can mean for health and wellness. “We are a new kind of pharma company,” the company states on their website. 

Statements like that reveal that the psychedelics industry has learned a lesson from the cannabis industry about how to position itself as a health and wellness substance first, and keep the pure fun of doing legalized psychedelics out of the picture entirely. 

The cannabis industry sprung out of the basements and backyards of black market growers and sellers who had no intention of using it medically. So, as the cannabis industry grew on the basis of how buzzed you can get with a higher THC level in your cannabis, with goofy stoner boys promoting their own brands, scaring the straights, as it were, the psychedelics industry developed by featuring guys in white lab coats and researchers with Phds carefully presenting results of clinical studies that demonstrated amazing medical breakthroughs. 

They stayed firmly legit, even getting the Food and Drug Administration to approve Compass Pathways as the first psychedelics company to get an FDA breakthrough therapy designation for its psilocybin therapy for treatment-resistant depression.

Now the recreational psychedelics folks want a piece of the psychedelics profits pie. But they are proceeding carefully. They started with decriminalizing psychedelics, taking a page from the cannabis playbook.

In fact, more and more cities have decriminalized psilocybin since May, 2019 (13 so far), with the state of Oregon both decriminalizing and legalizing psilocybin. Oregon Measure 109 would allow anyone over 21 to purchase, possess, consume, and experience the effects of psilocybin only at a licensed psilocybin service center during a psilocybin administration session with a licensed psilocybin service facilitator.

Depending on how the Oregon measure is interpreted, and depending on how other cities and states interpret that document when they look at doing their own versions of recreational psychedelic sales, will there be different brands of ‘shrooms available in retail stores in Oregon that will somehow bypass the “licensed psilocybin service center” requirement and just sell you a baggie curbside? Will those Oregon rules be re-interpreted by other states as time goes on? 

Entrepreneurs are already exploring the space of legalized recreational psilocybin, such as Synthesis Retreat in Amsterdam monitoring Oregon’s efforts. The company offers spiritual retreats for the psychedelic seeker. “Our genuine mission is to introduce psychedelics to mainstream culture in a responsible way, so that the people who could benefit the most will be able to access them,” their website states.

These early legalized psychedelics days are nothing like the heyday of early cannabis legalization days, where any buzz-worthy outing was just you and a couple of friends laughing at getting away with getting high. 

Legalized recreational psychedelics appear to be about serious mental health help, not about goofing and giggling a night away. They are therapy. They offer self-exploration. In short, they offer nothing recreational at all.. for now.


Dave HodesJanuary 13, 2022
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On December 20, 2021, breakthrough research at the Usona Institute, a 501(c)(3) non-profit medical research organization based in Madison, Wisconsin, revealed the true crystal forms of pharmaceutical psilocybin. It’s a new discovery of characteristics of the polymorphs of the plant that have always existed but were not detected until now.

But that discovery has ignited controversy within the psychedelics industry about synthetic psilocybin patents being sought by Compass Pathways (NASDAQ: CMPS), one of the leading psychedelics product development companies, using what they said is their original discovery of essentially the same polymorph that the Usona research reported already existed.

The new Usona Institute study laid out the experimental challenges to solve the crystallographic puzzle of synthetic psilocybin, bringing clarity to the polymorphs (unique crystalline arrangements) that naturally occur from the production of synthetic psilocybin. 

Usona claims that the study conclusively shows that three psilocybin polymorphs repeatedly occur from the well-known crystallization process, and that they have appeared in numerous places throughout the history of synthesizing psilocybin since 1959. 

In short, the study finds that there is nothing new to see here.

But Compass Pathways sees it differently. The company said they invented the crystalline form of psilocybin used in their synthesized psilocybin formulations, polymorph A, and want to patent it. Not so fast, the experts says.

The rise of the patent conundrum

The team of Usona chemists and collaborating crystallographers say that they already solved key psilocybin crystal structures using powder X-ray diffraction (PXRD) data collected on psilocybin at the Advanced Photon Source synchrotron at Argonne National Laboratory. 

In the Usona process-scale crystallographic research investigation, three crystalline forms of psilocybin were repeatedly observed: hydrate A, polymorph A, and polymorph B. The crystal structure for hydrate A had already been solved using X-ray diffraction. 

Usona’s study presents key new crystal structure solutions for the two anhydrates, polymorphs A and B, previously unidentified but part of the crystal structure dating back to when the crystalline structure was first reported in the 1970’s. 

Dr. Alexander Sherwood, lead author of the study and medicinal chemist at Usona, said they were just following clues available to any researcher to put together a full, clear picture of the three psilocybin polymorphs. “The process for isolating and crystallizing pure psilocybin has been consistently reproduced since first reported in 1959, and many different clues throughout history pointed to three psilocybin polymorphs resulting from that process,” he said. “The crystal structure solutions unified all the old evidence and data with precision and elegance. Once we put it all into one place, the full picture came together to tell a complete and compelling story about psilocybin crystallization.”

Then.. the twist

That data, that new discovery information from a non-profit company just wanting to advance the science of psilocybin, is creating conflicts between purists who say psilocybin should not be subject to patents and companies looking to build capitalist enterprises based on patenting such new product discoveries.

That’s where Compass Pathways comes in. Compass Pathways has developed a synthesized formulation of psilocybin, COMP 360, which uses crystalline psilocybin, and, in November, 2021, was granted its fifth U.S. patent by the U.S. Patent and Trademark Office (USPTO)—U.S. Patent No. 11,180,517—which covers methods of treating treatment-resistant depression (TRD) with crystalline psilocybin. 

A petition filed December 15 will challenge the patent granted on March 16, 2021. Additional petitions challenging Compass’ patents from the Freedom to Operate (FTO), a non-profit seeking to advance science and education by fighting bad and mistakenly issued patents, are expected.

The December 15 FTO petition quoted expert declarations filed with it from Dr. Sven Lidin (dean at the Lund University in Sweden) and Dr. James Kaduk (professor of chemistry at Illinois Tech and contributor to the Usona study) who explained that “’Polymorph A’ is a mixture of known psilocybin polymorphs, not a new polymorph as claimed. Compass’s patent is therefore invalid as claiming a nonexistent polymorph..”

So can Compass still claim to have identified a new crystalline structure—a so-called novel variant as mentioned in their patent application—for their synthetic psilocybin? Or does this finding by Usona and statements in the filing challenging Compass now negate the Compass Pathway’s synthetic psilocybin patents?

 Usona reseachers also addressed this in their study: “Revision is recommended on characterizations in recently granted patents that include descriptions of crystalline psilocybin inappropriately reported as a single-phase ‘isostructural variant.’”

In other words, the Compass patents using crystalline psilocybin are at best controversial—and at worst, null and void. 

But the Usona Institute v. Compass Pathways disagreement serves to illustrate a deeper and growing issue between non-profit psychedelics companies like Usona who just want to create and advance better therapies to treat human conditions, and for-profit companies like Compass who want to build an enterprise trying to control access and use of a natural product. 

The questions for the psychedelics community are: Who can commercialize, and control, psilocybin? Or.. should that ever happen?

“No one objects to Compass manufacturing and distributing psilocybin for medical uses, and certainly not me,” Carey Turnbull, founder and director of FTO, in a letter from the founder. “On the other hand, Compass has used their resources to try to prevent anyone but themselves from manufacturing and distributing psilocybin. That’s the rub.”

He continues: “(Compass) is attempting to patent things they should know they did not invent. Patents are not a systemic fault of the system; bad patents that attempt to appropriate pre-existing knowledge from the public commons and then ransom it back to the human race are a misuse of that system.”


Debra BorchardtJanuary 11, 2022
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Field Trip Health Ltd. (NASDAQ: FTRP) announced that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for Field Trip’s patent application No. 17/364,047 for claims related to FT-104 (informally known as “Isoprocin Glutarate”), Field Trip’s first novel psychedelic molecule in development. FT-104 is being developed as a more efficient treatment with the experience lasting less than four hours. It has a potency and pharmacology similar to psilocybin and the cost and accessibility are also better with this compound. Claims in the allowed patent application titled, “Tryptamine Prodrugs”, cover the composition of matter, use, and manufacturing of a family of hemi-ester compounds of hydroxytryptamines, including FT-104.

Dr. Nathan Bryson, Field Trip’s Chief Science Officer said in a statement, “Since inception, the strategy at Field Trip for our first development project was to create a novel drug substance that could produce a consistent trip time, in the range of three hours. We achieved this by combining a novel prodrug strategy to make demonstrable improvements on a known class of psychedelic substances. To further de-risk the project, we filed a Track One U.S. patent application on June 30, 2021, in order to accelerate the decision by examiners and achieve allowance, and granting, as early as possible in the development process. We are elated that the USPTO has formally allowed our patent application within seven months of filing and are now poised to continue development of FT-104 knowing that we have a robust intellectual property position to build on.”

Notices of Allowance are issued by the USPTO after it has thoroughly examined a patent application to ensure it complies with all requirements under United States patent law. This includes a rigorous evaluation to confirm that the claimed subject material is both novel and non-obvious with respect to prior art. The formal granting of the patent will occur in a subsequent administrative step.

FT-104 is a more soluble, more stable prodrug form of 4-hydroxy-N,N-diisopropyltryptamine (4-HO-DiPT or “Isoprocin”). The psychedelic compound, 4-HO-DiPT, was previously synthesized by Alexander (Sasha) Shulgin, a chemist and psychopharmacologist, who not only self-administered many of the substances he made but also reported their psychoactive effects in the collective works called “Tryptamines I Have Known and Loved,” or TIHKAL for short. In his works, Shulgin stated: “​​I truly doubt that there is another psychedelic drug, anywhere, that can match [4-HO-DiPT] for speed, intensity, brevity, and sensitive to dose, at least one that is active orally,” adding that “To be on a trip, then to be back pretty much in two hours and really baseline in another hour? Most unusual. If there will ever be an acceptance of drugs such as these, in a psychotherapeutic context, a short duration is of extreme value to both the patient and the therapist.”

Joseph del Moral, Field Trip’s CEO added: “We designed FT-104 to provide a more convenient, practical, and consistent experience while retaining the characteristics of a classical serotonin psychedelic. These aspects are important therapeutic and commercial differentiators which may truly separate FT-104 from psilocybin for clinical operators and for patients seeking psychedelic psychotherapy.”


Debra BorchardtJanuary 11, 2022
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Awakn Life Sciences Corp. (OTCQB: AWKNF) reported positive data from its Phase II A/B trial. It was the first controlled trial to investigate Ketamine-Assisted Therapy for the Treatment of Alcohol Use Disorder (AUD), the results have been published in the American Journal of Psychiatry. Awakn said the double-blind placebo-controlled trial included 96 patients with severe AUD, who were randomized to one of four groups: 1) three ketamine infusions (0.8 mg/kg IV over 40 minutes) plus proprietary manualized therapy (KARE); 2) three saline infusions plus KARE therapy; 3) three ketamine infusions plus alcohol education; and 4) three saline infusions plus alcohol education.

The findings showed that ketamine combined with KARE therapy, resulted in total abstinence in 162 of 180 days in the following 6-month period, achieving an increase in abstinence from around 2% prior to the trial to 86% post-trial. The results for relapse at 6 months, showed that the Ketamine plus KARE group’s risk of relapse was 2.7 times less than the placebo plus alcohol education group.

“Alcohol Use Disorder is a pervasive and persistent public health issue, affecting at least 390 million people globally. Treatment rates are low and relapse rates post-treatment tend to be high. We urgently need new and more effective treatments,” said Prof. Morgan. “We found that controlled, low doses of ketamine combined with manualized psychological therapy can significantly increase post-treatment abstinence rates. This is extremely encouraging, as we normally see three out of four people returning to heavy drinking within twelve months of treatment. The data we’ve collected from this study paves the way for a paradigm shift in how AUD is treated.”

Prof. Morgan identified further significant results in the reduction in heavy drinking days. At six months post-trial, there was an average of 12 heavy drinking days in the Ketamine plus KARE group, this is a large reduction compared to other trials in this area and it is widely believed the real-world data is far higher than this. Within the KARE group, there was also a significant decrease in the risk of mortality, 1 in 8 patients would have died within 12 months without treatment, that number decreased to 1 in 80 following the treatment. In total, the trial demonstrated that three subanesthetic infusions of ketamine support abstinence from alcohol and that abstinence may be further enhanced when ketamine treatment is combined with therapy. No serious adverse events took place during the trial.

Anthony Tennyson, Awakn’s Chief Executive, added, “We are so pleased to see such encouraging results in an area of treatment that has been stagnant for so long, leaving so many people with little or sub-par options available to them. We will continue to support this research and future clinical trials as we push to bring a radical shift in the alcohol addiction treatment industry.”

The company said the trial was conducted by the University of Exeter (UoE) and led by Professor Celia Morgan, Awakn’s Head of Ketamine-Assisted Therapy for Addiction and Professor of Psychopharmacology at UoE. Awakn acquired the intellectual property (IP) to the therapy under license for use in further research, its clinics in Europe, and its partnerships globally. The positive Phase II trial outcome and Awakn’s newly formed partnership with the UK National Healthcare Service (NHS) and UoE, paved the way to progress this trial into Phase III. With the ultimate aim of securing regulatory approval for Ketamine-Assisted Therapy to treat AUD in the UK through the NHS and potentially in other territories.

 

 


StaffDecember 20, 2021
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Havn Life Sciences Inc. (CSE: HAVN) (OTC: HAVLF) is buying functional mushroom wellness brand Spore Life Sciences Inc. Toronto-based Spore Life Sciences Inc. has a significant U.S. consumer base of more than 110,000 Spore customers, nearly 40,000 subscribers, resulting in year to date revenues as of the end of November 2021 of nearly C$8 million, and current sales of more than $1 million per month.

“With this Definitive Agreement, Havn Life is looking to strengthen its position as a leader in brain health focused nutritional supplements,” says Havn Life CEO Tim Moore. “Upon completion of the Acquisition, we will add these high-quality formulations to the Havn Life natural health product portfolio,” he adds.

Spore was co-founded by CEO and president Michael Zavet, who began looking into the beneficial properties of functional mushrooms to deal with his own personal health matters. Michael Zavet, the current Spore Life Chief Executive Officer and President will stay on to provide the services of Chief Revenue Officer and have a consulting agreement with Neon Flux LLC to provide marketing and advertising services. Alex Kaplunov, the current Chief Financial Officer and Secretary of Spore will stay on to provide the services of Chief Business Development Officer.

Spore’s third-quarter 2021 net revenue could surpass C$3 million and net monthly revenue in October and November 2021 alone of nearly C$3.6 million. Spore currently sells its line of products in the United States, with majority of its sales through its DTC website, and the remaining sales coming through Amazon.com, and select other eCommerce resellers. In 2022, Spore plans to expand to other geographies, including Canada where Spore has five Natural Product Numbers and the four others submitted to Health Canada, and grow into a full omnichannel wellness company.

The completion of the deal will bring in nine additional formulations under the Havn Life retail brand, adding to the company’s growing selection of natural health products that support overall health and cognitive function. Havn Life has agreed to issue up to $11 million worth of common shares to the former shareholders of Spore, and up to $19 million worth of common shares to certain consultants that will join Havn Life upon completion of the acquisition.

“We are very excited about this potential partnership and believe that Havn Life’s strong leadership team in the psychedelic space, its experience with natural health products, and network in retail are extremely complementary to our business,” says Spore CEO, Michael Zavet. “We are also excited to support Havn’s psychedelic endeavors through our digital marketing channels and large customer base,” he adds.


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