Psychedelics Archives - Page 2 of 14 - Green Market Report

StaffNovember 2, 2021
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Exclusively-natural psychedelic drug discovery company Filament Health Corp. (OTCQB: FLHLF) (NEO: FH)  received authorization from the FDA authorization to initiate the first clinical trial using naturally-sourced psychedelic substances. The news caused the stock to jump over 11% in early trading.

The company said that this approval is the first for the direct administration of psilocin rather than its prodrug psilocybin and will administer Filament’s three proprietary botanical drug candidates. The phase 1 trial is led by the Translational Psychedelic Research Program (TrPR) at the University of California San Francisco (UCSF).

“We are excited to announce this milestone as validation of our ability to cultivate variable psychedelic biomass and transform it into pharmaceutical-grade drug candidates,” said Chief Executive Officer, Benjamin Lightburn. “Our innovative technology has allowed us to create IP-protected botanical drug candidates of oral psilocin, sublingual psilocin, and oral psilocybin, and to enter them into an FDA-approved natural psychedelic clinical trial. Our candidates enjoy significant IP protection, unlike most other psychedelics currently under clinical investigation.”

The phase 1 trial has been designed to include 20 healthy subjects and will examine the effects of Filament’s three proprietary botanical drug candidates: PEX010 (oral psilocybin), PEX020 (oral psilocin), and PEX030 (sublingual psilocin). As a result of the need for psilocybin to convert into psilocin before becoming active in the human body, the direct administration of psilocin may yield several therapeutic benefits such as faster onset time, greater consistency, increased bioavailability, and lessened side effects. These potential attributes are being studied in the authorized trial. In addition, psilocin is an ideal candidate for sublingual delivery because of the bypassing of the gut, where the conversion to psilocybin is thought to primarily occur. To date, synthetic manufacturers have been unable to produce a stable formulation of psilocin and enter it into a clinical trial.

“My team and I are very excited to begin dosing Filament’s drug candidates in our clinic,” said Dr. Josh Woolley, MD/Ph.D., Director of TrPR and the study’s Principal Investigator. “The oral and sublingual administration presents an opportunity to learn about psilocin’s effects compared to psilocybin and perhaps set a new standard for psychedelic assisted therapy.”


StaffOctober 28, 2021
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Psychedelic biopharmaceutical company GH Research PLC (NASDAQ: GHRS) saw its shares pop over 15% in trading after the company was named in a hedge fund purchase. Mark Lampert’s Biotechnology Value Fund initiated $200 million worth of brand new positions in depression drug-focused GH Research, making it the largest stock holding of the fund’s 13F portfolio.

Last month, the company noted that it has $292 million in cash and the net loss was $2.1 million, or $0.053 loss per share. Its R&D expenses were $2 million for the quarter versus just $39 thousand for the same quarter in 2020. The increase was primarily due to increased activities relating to its technical developments and clinical trials and increases in employee expenses to support these activities. The stock was rising 17% at one point in trading, but was lately selling at $19.47. GH Research went public in June pricing shares at $16.

GH Research reported that its inhalable 5-Methoxy-N, N-Dimethyltryptamine (5-MeO-DMT) product candidate also called GH001, is currently being investigated in the Phase 2 part of an ongoing open-label, single-arm Phase 1/2 clinical trial in patients with Treatment-Resistant Depression (TRD). “Based on the observed clinical activity in the Phase 1 part of the trial, we believe that administration of a single dose of GH001 has the potential to induce ultra-rapid remissions as measured by the Montgomery–Åsberg Depression Rating Scale, or MADRS, in certain patients. The goal of the ongoing Phase 2 part, which we expect to complete in the fourth quarter of 2021, is to assess whether an individualized dosing regimen with intra-subject dose escalation within a single day can further increase the MADRS remission rate as compared to a single dose of GH001.”

We have previously announced the plan to conduct a clinical pharmacology trial in healthy volunteers to further elucidate the pharmacokinetic profile of GH001. This trial has been initiated and is expected to be completed in the fourth quarter of 2021.

GH Research said that once these studies are completed, it plans to request a pre-IND meeting with the FDA and a Scientific Advice meeting with the EMA and plan to initiate a multi-center, randomized, controlled Phase 2b trial in TRD. “Given GH001’s mechanism of action, we believe that GH001 may confer beneficial effects as an earlier line of treatment in MDD, including the potential to serve as a front-line treatment, as well as in other psychiatric and neurological disorders with unmet medical needs. We plan to initiate proof-of-concept Phase 2a trials in two such disorders.”

DMT

The 5-MeO-DMT is analogous to the N,N-DMT, one of the main active ingredients of Ayahuasca, a millenarian decoction used as a sacrament by South American indigenous tribes, known to induce powerful hallucinogenic states when administered. Itn addition to being found in plants, it is also secreted by the glands of at least one toad species, the Sonoran Desert toad.


StaffOctober 6, 2021
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Despite impressive growth and acceptance by the mainstream financial world, the psychedelic medicine industry is still in its infancy. The first companies went public in the spring of 2020, making the psychedelics industry a newcomer on the biotech scene. Despite this, the sector is continuing to take big strides, getting institutional investment and listings to major American exchanges like the NASDAQ and NYSE. 

A missing piece of the sector’s growth puzzle was industry events and in-person networking. With Covid-19 shutting the world down just as psychedelics firms were launching, the industry missed this crucial part of its evolution. However, with restrictions beginning to ease, the industry now has a chance for the all-important networking, education, and dynamic interactions that can only happen when people are able to meet face to face. While some other smaller industry events have been happening for a few years, an upcoming event is looking to establish itself as the go-to psychedelic medicine gathering. 

Wonderland by Microdose Psychedelic Insights 

Since its inception less than 2 years ago, Microdose has quickly established itself on the business side of psychedelic medicine. The media company has been running virtual events for over a year, with dozens of virtual conferences that have brought together industry leaders, CEOs, scientists, and investors. Its Psychedelic Capital and Molecular Masterclass series has been highly successful in helping the industry come together and virtually network. 

Now Microdose is taking the next step with Wonderland. Wonderland will take place November 8-9, 2021 at the Adrienne Arsht Center for the Performing Arts in downtown Miami. The event will be the industry’s largest-ever event, with over 2,000 attendees and an impressive line-up of industry researchers, investors, journalists, and CEOs.

As described in the company’s press release: Wonderland: Miami will offer the industry a unique in-person convergence of business, science, music, and emerging technologies. The event is a thought-leadership platform and an opportunity to connect with influential leaders in science, policy, and business. It will also act as a launching pad for innovative content connected to the psychedelic medicine space, with musical showcases and documentary screenings, providing compelling entertainment and collaboration opportunities for attendees.

Microdose has announced an impressive line-up of speakers, here are some highlights:

Mike Tyson, Wesana Health

Mike Tyson, an investor in Wesana and company advisor, has suffered from traumatic brain injury. The former heavyweight champion says psychedelics would have helped him with his mental health during his career.

Lamar Odom, Mental Health Advocate

Lamar Odom, two time NBA Champion, Olympic Gold Medalist, NYT best selling author, and ex-addict is now stepping into his second half in life as an astute businessman, mental health advocate and mentor.

Dr. Robin Carhart-Harris, PhD, Professor of Neurology & Psychiatry

Robin Carhart-Harris has published over 115 scientific papers. He founded the Centre for Psychedelic Research at Imperial College London in April 2019. In 2021, he was listed in TIME magazine’s ‘100 Next’, a list of 100 rising stars shaping the future. 

Dr. Matthew Johnson, Johns Hopkins University School of Medicine

Matthew W. Johnson, Ph.D., is The Susan Hill Ward Endowed Professor of Psychedelics and Consciousness Research at Johns Hopkins University School of Medicine. He  is one of the world’s most widely published experts on psychedelics, publishing over 150 scientific papers. He has been interviewed by Anderson Cooper on 60 Minutes, the New York Times, the Washington Post, the Wall Street Journal, the BBC, CNN, Fox Business News, NPR, and in Michael Pollan’s book How to Change Your Mind.

Rick Doblin, Executive Director MAPS

Rick Doblin, Ph.D., is the founder and executive director of the Multidisciplinary Association for Psychedelic Studies (MAPS), an organization that’s been leading the charge for the advancement of psychedelics for decades. 

In addition to top speakers, the event will also offer a range of programming that will span a variety of topics surrounding the psychedelics industry and beyond. Some examples include:

 

  • The Pathway to Federal Acceptance
  • Next-Generation Psychedelics
  • Microdosing: Fact or Fiction?
  • Patent Wars
  • Finance and Psychedelics

 

From Richard Skaife, the chair of Microdose and Founding Partner at The Conscious Fund: 

”We launched Microdose at the start of what was to become a global lockdown for most of the world; quickly becoming a category leader in virtual events and sector insights for the psychedelic medicine industry. Jumping forward by 15 months as the world starts to return to an open economy we are delighted to bring our next event format to life: Wonderland, from Microdose.

Wonderland is all about real-life events. High-quality programming in some of the world’s most exciting locations and breathtaking venues. Wonderland in Miami will be for many the first time the industry has come together in person. We can’t wait to welcome you to Miami to see what we have created.”

Wonderland will take place November 8-9, 2021. For more information on the event, check out the Wonderland website.


Julie AitchesonSeptember 30, 2021
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You may have heard of “functional fitness” (which trains the body for activities performed in daily life) and  “functional nutrition” (a philosophy that promotes the use of food as medicine to prevent and alleviate diet and lifestyle-related diseases), but have you heard of “functional mushrooms”? If you’ve been down the aisle of a Whole Foods in the last few years, you undoubtedly have, but in case you haven’t, functional mushrooms include strains like Lion’s Mane, Cordyceps, and Chaga that aren’t only a food source but have beneficial properties that can positively impact health. These multitasking mushrooms have been showing up everywhere from coffee to candy bars, and while initially, they were giving cannabis a run for its money as the latest wellness trend, many companies are now blending THC or CBD and medicinal mushrooms to create “super” supplements, edibles, and other products to tempt the health-conscious consumer.

Cookies, an international cannabis brand, just launched Caps by Cookies THC, which is a three-in-one capsule formulation that blends non-psilocybin organic medicinal mushrooms and potent cannabis compounds. The mushrooms for Cookies’ formulation, which are high in beta-glucans, ergosterol, full-spectrum and grown to maturity, are provided by mushroom extract manufacturer Nammex and encapsulated by Blue River

But Cookies isn’t the only company marrying mushrooms with cannabis. TerraVita now offers two formulations, Relax CBD capsules and Shroom capsules, which blend mushrooms with CBD. TerraVita’s Shrooms bled contains Reishi, Cordyceps, and Lion’s Mane in a formula geared towards fortifying the immune system, relieving stress, and boosting cognitive function, while the Relax formula combines Reishi with the ayurvedic herb Ashwagandha, GABA, and L-Theanine to calm and restore.

Pantry’s Good Day Bites are getting attention for their line of superfood bites which contain 5 milligrams 1:1 THC:CBD as well as adaptogens and functional mushrooms. Pantry solicited the culinary expertise of nutritionists, doctors, and Michelin star chef Michael Magliano to come up with their line of medicinal treats. The line also includes Nite Bites and Cacao Keto Bites, which contain mushrooms, adaptogens, and cannabinoids like THC, CBD, and CBN. Pantry’s website has a dosage calculator to help customers figure out how much of these dime-sized chocolates to consume in order to achieve the desired quantity of “good vibes”.

 Buddha Teas, HempWorks, and 7 Wonders Mushrooms are also recruiting functional mushrooms to the cause of optimal health, with more companies rallying to the trend. Consumers can expect to see more products that celebrate the synergy of cannabis and functional mushrooms, as scientists hustle to provide the research to keep up with (and substantiate) the combination’s growing popularity. 


StaffSeptember 27, 2021
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Delix Therapeutics closed on a $70 million Series A financing round.  The company said it expects to use the money to advance two lead candidates through Phase 1 clinical trials, further expand its drug discovery platform of novel neuroplasticity-promoting compounds known as psychoplastogens, and expand its team.

“We appreciate the overwhelming support from new and early investors alike, and continue to attract top neuroscience, chemistry, and biotech talent as we pursue a unique pathway toward treating – and potentially healing – neuropsychiatric conditions in a new way, at scale,” said Mark Rus, Delix Therapeutics CEO. “We’ve made tremendous progress towards developing efficacious and easily manufactured compounds that have the potential to deliver safe, fast-acting, FDA-approved treatments to help patients in need.”

Delix Therapeutics was co-founded by Nick Haft & David E. Olson and was built upon the discovery of Dr. Olson, together with his team at the University of California, Davis, that non-hallucinogenic psychoplastogens are capable of producing sustained therapeutic effects. Olson’s research and Delix’s discoveries have been widely published in Cell, Nature, Molecular Psychiatry, Cell Reports, and other leading peer-reviewed scientific publications. Delix has produced nearly 1,000 novel compounds to date, with several potential clinical development candidates identified. Delix said that its improved safety profile, non-hallucinatory efficacy, and simplified manufacturing process of its psychoplastogens make its novel compounds highly scalable and suitable for early use in patients. DLX-1 and DLX-7, the first two development candidates to emerge from Delix, are currently undergoing pre-IND safety and toxicology studies to enable clinical trials to begin in 2022.

Senior Partner of ARTIS Ventures and Delix Board Member Vasudev Bailey said, “Delix is at the forefront of neuroscience with a growing platform of novel compounds, a great team, and a novel approach. Delix has the potential to advance our understanding of neuroplasticity, a core component of psychedelics, and its ability to heal. Through its platform, we see a significant opportunity for Delix to develop next generation therapies, with strong IP protection and the potential to positively impact a range of neuropsychiatric and neurodegenerative conditions.”

Andrew Levin, Managing Director at RA Capital Management, added, “The healthcare system is in serious need of new and improved neuropsychiatric treatments that are scalable and more accessible than first- or second-generation psychedelics. We have been looking for an optimized scientific approach to achieve this, and believe that Delix’s team, therapeutic strategy, and early lead candidates are on the critical path.”

The round was led by ARTIS Ventures, RA Capital Management, and founding investor OMX Ventures, with participation from a diverse syndicate of life sciences and psychedelic investment funds. Additional investment funds participating in the round include Apeiron, Bail Capital, Casa Verde Capital, Dolby Family Ventures, Negev Capital, Noetic Fund, Ocama Partners, Palo Santo, Presight Capital, PsyMed Ventures, R2, Re.Mind Capital, Saya Bio, Vertical Venture Partners, WPSS, and other leading family investment funds.

“This funding is an important step in transforming our years of scientific research and discoveries into innovative treatments for patients in need,” said Professor David E. Olson, co-founder and Chief Innovation Officer of Delix Therapeutics. “Our preclinical data to-date suggest that our compounds are unlike anything currently in psychiatrists’ arsenals and have the potential to treat a wide range of conditions. Because the Delix platform directly reverses cortical atrophy — the root cause of many brain disorders — we are optimistic that our treasure trove of novel compounds will yield many safe and scalable treatments for improving mental health.”


StaffSeptember 16, 2021
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It’s been a busy week for psychedelic company Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) who reported its financial results for the quarter ending July 31, 2021, and announced an acquisition. On Wednesday, Awakn reported its earnings, but the relatively new company has no revenues to speak of. Instead, the company reported that it had a net loss of $9.1 million for the six months ending in July. Awakn also addressed its situation as a going concern due to its lack of incoming revenue.

However, it has been able to raise money and currently has $8.7 million in cash. The company completed a $8.3 million financing at $2.50 per share in conjunction with its listing on the Neo Exchange. CEO Anthony Tennyson said, “We have also made significant strides in the development and delivery of psychedelic therapeutics to treat Addiction and continued to progress the opening of our first clinics. We remain steadfast in our mission to fully integrate effective psychedelic-based treatments into mainstream healthcare to better treat Addiction.”

Following the earnings announcement, Awakn said it has signed a binding share exchange agreement to acquire a 100% interest in Axonklinikken AS (“Axon”), a leading ketamine-assisted psychotherapy clinic in Norway. As part of the transaction Axon will be renamed ‘Awakn Oslo AS’, and Axon’s majority shareholder Dr. Lowan Stewart will be appointed as Regional Director for the Nordics and Managing Director Awakn Oslo AS. Awakn said the acquisition will help it to speed up its clinic roll out program, as Awakn will now parallel path its regional expansion plans in both the Nordics (Norway, Sweden, Denmark, Finland and Iceland) and U.K. & Ireland.

“This is a key element of our goal for Awakn to become the leading authority in the development and delivery of psychedelic therapeutics to treat addiction,” said Anthony Tennyson, Awakn’s CEO. “Our approach of development and delivery enables Awakn to earn revenue while we also develop a deep IP portfolio with strong commercial potential. This acquisition will enable Awakn to accelerate the first element of our three-pronged revenue generation strategy: clinics in the UK and Europe, licensing partnership beyond the UK and Europe, and therapeutics commercialization.”


StaffSeptember 2, 2021
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Co-founder of Bright Box, the leading Connected Car technology provider, responsible for strategic decisions, fundraising and M&A. Bright Box was acquired by Zurich Insurance Group in 2018. Co-founder of BrightConsult, the top software partner of Microsoft in Eastern Europe in the Automotive industry. Company was acquired by Incadea Gmbh in 2011. As a private investor did more than 30 transactions with early- and late-stage companies in the US, Israel, and EU.

 

GMR Executive Spotlight Interview Q&A:

 

Full birth name: Ken (Innokenty) Belotsky

Title: Partner

Company: Negev Capital

Years at current company: 1

Most successful professional accomplishment before psychedelics: two successful exits from startups, where Ken was a co-founder, with 25x+ return for the seed investors

Company Mission: Negev Capital the USD$25+ million fund is in the battle against the current Mental Health Pandemic by investing in companies that develop novel drugs for psychiatric disorders based on psychedelic compounds. 

Company’s most successful achievement: Over $9M USD invested in 14 companies that develop novel drugs for psychiatric disorders based on psychedelic compounds over past 6 months. 

Has the company raised any capital (yes or no):  Yes. 

If so, how much?:$20M+ USD 

Any plans on raising capital in the future? We are always looking for suitable LP’s to work with on a mission to battle against the current Mental Health Pandemic.

Most important company 5 year goal: We believe that psychedelic medicine will be not only disruptive to the practice of psychiatry, but hold the potential to reduce enormous amounts of human suffering, and we are committed to helping the field mature, and further promote ways for these treatments to reach all of those in need. 


StaffAugust 30, 2021
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Psychedelic companies Red Light Holland Corp. (CSE: TRIP) (OTC Pink: TRUFF) and Creso Pharma Limited (ASX: CPH) (OTCQB: COPHF)  have mutually agreed to terminate the previously announced plan to merge. The two companies had announced in June they would combine, but now cite various impacts from the COVID-19 pandemic, including significant travel restrictions, where they decided that the merger would no longer be in the best interests of their respective shareholders.

“While we determined that a merger was no longer in the best interests of the two companies, we look forward to continuing to work closely with Adam Blumenthal and the rest of the Creso Pharma team as Red Light Holland has agreed to white-label Creso Pharma’s products and distribute them across our SR-Wholesale sales channels,” said Todd Shapiro, CEO and Director of Red Light Holland. “We are also continuing our search for other M&A opportunities as we are confident that our large cash balance puts us in a position of strength as potential progressive regulatory changes in the North American psychedelic and recreational cannabis sectors open up.” Red Light Holland did not that Bruce Linton, the founder and former chief executive officer of Canopy Growth Corporation, will remain as a Chairman of Red Light Holland’s Advisory Board.

As the two companies have significant operations in multiple countries across the globe, the two said that it became increasingly apparent that integration difficulties would limit the anticipated synergies from the proposed merger. The two companies were going to create a new business named The HighBrid Lab. The transaction was to be a reverse takeover of Red Light Holland by Creso Pharma giving Red Light shareholders a 29% premium for their shares. Creso shareholders would’ve owned 57% of the new company.  The new company was expected to have a cash balance of approximately C$45 million.

“We respect Todd Shapiro and the entire team at Red Light Holland. Unfortunately, the geographic span of our respective businesses made a merger at this time impractical,” added Creso Pharma’s Non-Executive Chairman, Adam Blumenthal. “We look forward to working with the Red Light Holland team through our new supply arrangement.”

 


Video StaffAugust 13, 2021
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This is Psychedellux the week’s top business headline in the psychedelics industry. 

Compass Pathways plc (Nasdaq: CMPS) reported its financial results for the second quarter of 2021 and gave an update on recent progress across its business. Compass reported a net loss for the three months ending June 2021 was $17.5 million, or $0.44 loss per share, (after including non-cash share-based compensation expense of $1.9 million) compared with $16.2 million, or $1.65 loss per share, during the same period in 2020 (after including non-cash share-based compensation expense of $9.7 million). The company is sitting comfortably on a pile of cash. Compass reported cash and cash equivalents of $316.3 million as of June 2021 versus $190.3 million as of December 2020. 

Revive Therapeutics Ltd. (OTCQB: RVVTF) said it is advancing the research and intellectual property acquired from PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) on psilocybin as a potential solution to managing TBI and stroke. Preclinical studies demonstrated that psilocybin, given after injury, improved cognitive function in TBI mice.

Seelos Therapeutics, Inc. (Nasdaq: SEEL) announced its mid-year 2021 business and clinical update. As of the end of Q2, Seelos had $87.2mm of cash. It currently has no outstanding debt and is making progress with various studies. 

Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) reported that it has qualified to trade on the OTCQB Venture Market under the ticker symbol “AWKNF” on Tuesday, August 12.

 

 

 


Debra BorchardtAugust 11, 2021
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Compass Pathways plc (Nasdaq: CMPS) reported its financial results for the second quarter of 2021 and gave an update on recent progress across its business. Compass reported a net loss for the three months ending June 2021 was $17.5 million, or $0.44 loss per share, (after including non-cash share-based compensation expense of $1.9 million) compared with $16.2 million, or $1.65 loss per share, during the same period in 2020 (after including non-cash share-based compensation expense of $9.7 million).

The company is sitting comfortably on a pile of cash. Compass reported cash and cash equivalents of $316.3 million as of June 2021 versus $190.3 million as of December 2020. “In May 2021, we closed an underwritten public offering, including the full exercise of the underwriters’ greenshoe option, and received net cash proceeds of approximately $154.8 million, after deducting underwriting discounts and commissions and other offering expenses.”

Compass also reported that the research and development (R&D) expenses were $11.4 million for the quarter versus $6.7 million during the same period in 2020. Of this increase, $4.7 million reflected increased development activities and $1.4 million related to hiring additional staff, as COMPASS progresses its COMP360 psilocybin therapy in TRD, and continues to explore additional indications and therapeutic approaches. There was a reduction of $1.7 million in non-cash share-based compensation expense compared with the same period in the prior year

George Goldsmith, Chairman, CEO, and Co-founder, COMPASS Pathways, said, “We have completed psilocybin therapy administration in our COMP360 phase IIb trial, a significant milestone in our journey to bring new therapies to patients suffering with treatment-resistant depression. This is the largest trial ever conducted in psilocybin therapy, and it was done amid the lockdowns and challenges of the COVID pandemic. We are well-positioned for recruitment to phase III, pending results from the phase IIb study, which are expected later this year.”

The company reported that its general and administrative (G&A) expenses were $8.2 million for the quarter versus $11.0 million during the same period in 2020. The decrease was attributable to reductions of $6.1 million and $0.5 million respectively in non-cash share-based compensation and legal and professional fees, offset against an increase of $1.8 million and $2.0 million respectively in personnel expenses and facilities and other expenses.

Psilocybin Update

Compass noted that its Phase IIb clinical trial of COMP360 psilocybin therapy for TRD was close to completion and the company said it was on track to report top-line data by end of 2021. COMP360 psilocybin therapy has now been given to 233 patients, exceeding 216 targets. A dose-finding study comparing 25mg and 10mg of COMP360 psilocybin with 1mg, given in conjunction with psychological support from specially trained therapists. It is the world’s largest psilocybin therapy trial, taking place in 22 sites across 10 countries.


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