Dave Hodes, Author at Green Market Report

Dave HodesJanuary 27, 2022
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Since opening its doors in 2019, Cybin, Inc., (NYSE: CYBN) based in Toronto, Ontario Canada has been on a mission to build a business in novel drug discovery (focusing on psilocybin and DMT), drug delivery systems, and treatment. 

It’s been on a fast track to make good on that mission. 

The company was the first psychedelics companies to be traded on the NYSE; it consistently makes business and stock watcher’s lists as one of the top psychedelics companies to watch; and it has 15 patent filings covering a wide range of novel psychedelic compounds from different classes, including targeted structural modifications to improve the drug pharmacokinetic characteristics and safety profiles without altering receptor binding.  “What we’ve been doing is very multi-dimensional,” Doug Drysdale, CEO of Cybin, told Green Market Report, referring to not only multi-faceted drug development but their Embark psychedelic facilitator training. “It’s not just about bringing a molecule to the clinic. We’ve been working to optimize these classical psychedelic molecules that we know a lot about, which are psilocybin and DMT. And we’ve been engineering them into different analogues and derivatives,” he said. “Ultimately, what we’re trying to do here is optimize the treatment for patients and for providers, because those are the hurdles you have to get through to have a successful product. It’s about optimizing the molecule to overcome some of the limitations, providing tools for therapists and providers, and then, at the same time, generating an IP to protect those investments.”

Drysdale said that there has been steady development work at Cybin to eventually get into human drug trials hopefully later in 2022, which is the next significant step in drug development.

As a pathway to get there, next month Drysdale and his team at Cybin are meeting with the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA), an executive agency of the Department of Health and Social Care, which regulates medicines, medical devices and blood components for transfusion in the UK. They will also be submitting findings to the FDA in the next quarter. “We are taking a very much pharmaceutical approach, a very robust and sound scientific approach to in these meetings with both the MHRA and FDA,” he said.

There are a number of challenges working with a new substance like psilocybin, the least of which is building a business that requires a lot of capital upfront and months or even years of expensive drug development. Drysdale has seen what has happened to some of the early startups in this space. “I think a lot of those companies that went public were under-capitalized,” he said. “Now that the market has shifted a little bit, I think we’re going to see some companies facing challenges this year, maybe not having access to capital that they need. We’re also going to see, I think, the continued emergence of IP patents being issued, which will create opportunities for some and challenges for others. So there’s no doubt in my mind that we’ll see a lot of consolidation this year, and perhaps, you know, six or 12 months from now, there may not be 50 or 60 psychedelics companies, but maybe 10 to 20.”

Cybin has raised $120 million since 2019; expanded operations into Europe; and entered into exclusive research and development collaboration agreement with TMS NeuroHealth Centers, a company doing transcranial magnetic stimulation operating 129 outpatient mental health service centers in the United States.

Cybin is working now on investigating how to make psilocybin work better for the mental wellness effect it’s targeting, including exploring safer dosing amounts for patients. “We all metabolize differently,” Drysdale said. “So one patient versus another might have quite a different experience. One might have a profound experience, one might have a mild experience, and that creates an awful lot of variability. We’ve addressed that with our psilocybin, analog CYB003, to minimize that variability, with the goal of having more predictable outcomes. We know we’re dealing with psychiatry patients here, so we want to make sure that the responses are more predictable.” 

The other challenge with psilocybin is that it’s slow-acting, and patients may be in the clinic for an entire day. “When we speak to providers, that’s a real challenge in terms of the staffing and infrastructure,” he said. “So we have worked to accelerate the onset of action, and shorten the duration of action of our psilocybin analog so that the patient spends half the time that they would have spent in the clinic.”

Is he tracking the growing acceptance of psychedelics in the U.S. as demonstrated by the uptick in decriminalization efforts? “That wave of decriminalization is more of a criminal justice issue than a pharmaceutical issue,” he said. “But on the pharmaceutical side, both FDA and the MHRA in the UK and the DEA have all made moves in recent months that are positive. I don’t think the regulations and the scheduling are going to be the biggest hurdles to approval at this point. I think the train has left the station. I think we’re definitely past that point. And now it’s all about doing the science, the hard work of making these into pharmaceuticals.”


Dave HodesJanuary 25, 2022
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Nearly every day, another new rule favoring the decriminalization of psychedelics or otherwise prompting favorable treatment of psychedelics is announced. Here’s a roundup of some of the most recent actions in January alone:

– January 19. After facing legal scrutiny for decades, psychedelics including MDMA and psilocybin received a stamp of approval from Health Canada for medical purposes. Canada’s legislation now permits the use of psychedelics beyond palliative care.

– January 18. U.S. Congressman Earl Blumenauer (D-OR) led a bipartisan group of six lawmakers in urging the U.S. Drug Enforcement Administration (DEA) to stop blocking terminally ill patients’ access to therapeutic psilocybin treatments. 41 state legislatures and the federal government have passed Right to Try (RTT) laws to allow terminally ill patients access to treatments, including psilocybin, that is still in investigational stages. The DEA, however, has refused to accommodate RTT laws, denying terminally ill patients their freedom to elect their preferred treatments.

– January 17. Missouri State Representative Michael Davis (R) reportedly filed a bill that expands Missouri’s Right to Try statute to include Schedule 1 investigational drugs, with a focus on psychedelic drugs including psilocybin, MDMA, LSD, and ibogaine. Davis filed an identical bill, HB 1176, in February 2021.

– January 17. Utah State Representative Brady Brammer sponsored HB 167 that creates the Mental Illness Psychotherapy Drug Task Force, requiring the task force to study and make recommendations on drugs that may assist in treating mental illness. Although not specifically mentioned in the bill, psilocybin is likely the “main ringleader” of drugs that would be considered by the task force, according to a report by KSL, a news radio station in Salt Lake City.

– January 12 – A second public hearing in the General Court of New Hampshire for HB 1349 is held to decriminalize psilocybin mushrooms. The bill would reduce possession of up to 12 grams to a violation with a $100 fine.

– January 12. Virginia Delegate Dawn Adams (D) introduced HB 898, a bill that provides any person 21 years of age or older who knowingly or intentionally possesses peyote, ibogaine, psilocybin, or psilocyn shall be punished by a civil penalty of no more than $100, and such civil penalties shall be deposited into the Drug Offender Assessment and Treatment Fund. Under current Virginia law, a person who knowingly or intentionally possesses such substances is guilty of a Class 5 felony. If convicted, the offender could be sentenced to 10 years in prison, or jail for not more than 12 months, and/or a fine of not more than $2,500.

– January 11. The International Therapeutic Psilocybin Rescheduling Initiative (ITPRI) is launched today. It is a global coalition working to promote and secure a rescheduling of psilocybin under the 1971 Convention on Psychotropic Substances. Advisory board members of the coalition include the Multidisciplinary Association for Psychedelic Studies (MAPS), Beckley Foundation, and the former Secretary to the World Health Organization (WHO) Expert Committee on Drug Dependence.

– January 11. The first reading in the Florida House of Representatives of HB 193 is held. The bill is sponsored by Florida State Representative Michael Grieco (D) would allow using alternative therapies to treat mental health and other medical conditions

– January 10. Kansas State Representative Aaron Coleman (D) introduces HB 2465 to decriminalize the possession, cultivation, and distribution of psilocybin. 

– January 5. Seven state senators in Washington State filed a bill, SB 5660, that would create a state-licensed program to provide medical treatment with psilocybin after an 18-month development period.

But that’s just January. Other legislation on the books for traction in 2022 include California’s psychedelics decriminalization bill SB 519; two psychedelics-related decriminalization initiatives slated to be on the November 2022 ballot in Colorado, Initiative 49 and Initiative 50; and Michigan SB 631, which would legalize possession, cultivation, and delivery of several plant and fungus-derived psychedelics, including psilocybin, mescaline, DMT, now in Committee on Judiciary and Public Safety.


Dave HodesJanuary 24, 2022
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An emerging trend in some bioscience startups is the development of both cannabis and psychedelics products. One such company is Enveric Biosciences, headquartered in Naples, Florida, which hopes to leverage psychedelics-derived molecules for the mind and create synthetic cannabinoids for the body in the treatment of cancer.

Enveric Biosciences focuses on synthesizing novel, tailored and highly differentiated derivative molecules based on classic psychedelics such as psilocybin, N,N-dimethyltryptamine (DMT), mescaline and MDMA. 

Given that the company is working with both plant-based substances, could Enveric somehow combine psychedelics and cannabinoids for some sort of synergistic wellness effect, or some way of benefiting the patient through a shared entourage effect?

Joe Tucker, CEO and director of Enveric Biosciences, said that Enveric doesn’t have any near term aspirations of literally combining cannabinoids and psychedelics. “Enveric is a drug development company” he said. “So when you go down that path, it’s generally about a single molecule, what a single molecule is doing, a single indication that you’re going after. But you can see numerous applications where a patient could take a cannabinoid for their cancer, and a psychedelic separately approved for their mental health, and it could be the same patient benefit for both.”

The company is developing next-generation oncology palliative care treatments by advancing novel combinations of synthetic cannabidiol (CBD) with other therapeutic agents for the treatment of cancer-related conditions, such as glioblastoma multiforme (an aggressive and incurable cancer located in either the brain or spine) and chemotherapy-induced neuropathy. 

The company is also working on a topical treatment for radiodermatitis (RID), which is a side effect of radiotherapy that creates lesions on human skin. 

Approximately 95 percent of patients receiving radiotherapy will ultimately develop RID during or after the course of treatment, with major consequences on quality of life and treatment outcomes, according to a study. Treatment for RID represents a $1 billion global opportunity, according to an Enveric company presentation.

On the psychedelics side of the company, Enveric is exploring treatments for helping cancer patients with mental health. A report from the War on Cancer found that 71 percent of participants said their mental health declined during cancer treatment. 

Development of these treatments begin when Enveric’s scientists synthesized newer versions of classic psychedelics using a mixture of chemistry and synthetic biology along with their Psybrary, a library included in their September, 2021, purchase of MagicMed for $48 million, which contains a large, diverse portfolio of molecular derivatives.

Their Psybrary has been reported to contain 15 patent families, but Tucker said there are actually more that exist, and more coming, with over a million potential variations and hundreds of synthesized molecules. “It’s a major asset within the company,” Tucker said.

The initial focus of the Psybrary is on psilocybin and DMT derivatives, and it is expected to be expanded to other psychedelics. “We spend a lot of our time thinking about how to create new molecules,” Tucker said. “We are targeting molecules that are going to outperform the classic psychedelics.”

He said that they are not attempting to “own” psilocybin or any other psychedelic plants, which has been the pushback that so-called patent-centric bioscience companies like his are getting from industry purists. “We’re creating novel molecules,” he said. “These things that we’re making are not in these sacred psychedelic plants. They’ve never existed before. We’re actually creating something that’s new.”

Enveric’s artificial intelligence tool, PsyAI, which Tucker said they built from scratch, enables the company to narrow down the potential compound variations to best target specific mental or physical ailments. PsyAI can help researchers at the company target indications and accelerate the pathway to an Investigational New Drug (IND) designation from the U.S. Food and Drug Administration (FDA).

Tucker explained how their PsyAI works: “There’s not that much in the scientific literature about psychedelics that you can go and say if I modify psilocybin, for example, to look like this new compound, how’s it going to work? That information does not exist for psychedelics, because they’ve been essentially illegal,” he said. 

PsyAI is used essentially to make up for that missing information, using computer modeling and programming based on the three-dimensional structure of the molecules and three-dimensional structure of the receptors that are being targeted, among other factors. 

“We look at our Psybrary of so many possible molecules, and say which of these are likely to, at the most basic level, bind to and switch on, activate or inactivate the receptors that we want to,” Tucker said. “What that really means is if you know enough about the indication, the mental health challenge you’re trying to treat, you can say turn these receptors on and turn these receptors off,” he said.

With PsyAI, you can look at a large potential list of drug candidates, and say which are the ones that are far more likely than a randomly selected molecule to give you exactly the outcome you want for the patient. “So it’s really a very powerful screening tool,” Tucker said.

The company has experienced some financial hiccups since its inception in 2021, according to SEC documents, and has been using available cash to fund their operations as the company geared up its research and development efforts—not unusual for a capital-intensive drug development company.

Research and development expense for the nine months ended September 30, 2021, was $2,295,826, compared to $134,259 for the comparable period in 2020, an increase of 1,610%. 

But the company also raised $25 million in 2021, in what Tucker called a “foundational year.” 

“The entire drug development industry took a nosedive, and psychedelics took an even harder nosedive than everyone else this past year,” Tucker said. “This year going forward is when I think the rubber is going to meet the road. The long-term investors are going to be the ones that look through the companies and see that there are a lot of companies out there. But which ones of these really have the legs, really have the technology, the intellectual property to actually see this drug development through and develop a winning, hopefully billion dollar, molecule?,” he said. “Those sophisticated, long-term fundamental investors are the ones that are going to be making sure certain companies are adequately funded and make it through the challenges ahead. So (2022) is going to be a turning point year for the industry, where the companies that have a lot of real pharmaceutical fundamentals behind them, in my opinion, are going to be supported.”


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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10min7600

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.”


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