This article was made possible thanks to invaluable research by Michael Haichin and Josh Hardman from Psilocybin Alpha.
In just a couple of years, psychedelics took the world of investing by storm.
What in 2019 was merely a buzzword for investors became a full-fledged industry boasting over 25 public companies, including six (and counting) that list their stock in the Nasdaq.
As the space progresses, investors are in search of data points that will enable them to track and compare the progress of psychedelics companies.
The sector is building itself as a complex industry with many verticals that range from specialized healthcare services to supply chain solutions and digital therapeutics.
However, drug discovery and development probably remain the most observed arm of the sector, as approval of psychedelic substances through the clinical trial pipeline is a clear path to revenue for any company in the space.
Taking these factors into account, Psilocybin Alpha built the Psychedelics Drug Development Tracker – an interactive list of clinical trials, preclinical and discovery work being done in the space.
Ongoing Phase 3 Trials
Currently, the only phase 3 clinical trial being carried out on a psychedelic molecule is MAPS’ study on the use of MDMA in post-traumatic stress disorder. The Multidisciplinary Association for Psychedelic Studies is a non-profit led by researcher Rick Doblin that has had a head start of at least three decades when it began its work to legalize the therapeutic use of MDMA as far back as 1986.
The organization expects to finish trials and be able to deliver MDMA therapy with FDA approval by 2023.
Ongoing Phase 2 Trials
A number of nonprofits, private and public companies in the space are pushing psychedelic substances through phase 2 clinical trials.
Compass (NASDAQ: CMPS) is currently working on a phase 2 trial of COMP360, a proprietary formulation of psilocybin being tested for treatment-resistant depression. Approval would grant the company five to seven years of exclusivity to market and commercialize psilocybin therapy and its protocols.
Wisconsin-based nonprofit Usona Institute is carrying out a phase 2 trial, which is looking at the use of psilocybin in around 80 patients with major depressive disorder.
Beyond form, the aforementioned phase 3 trial on MDMA for PTSD, the Multidisciplinary Association for Psychedelic Studies is also looking at MDMA for other indications in phase 2 trials such as eating disorders (anorexia nervosa and binge eating disorder), anxiety associated with a life-threatening illness and social anxiety in autistic adults.
Mind Medicine Inc. (NASDAQ: MNMD), better known as MindMed, is leveraging a wide-ranging partnership with the Lietchi Lab at University Hospital Basel in Switzerland to carry out two phase 2 clinical trials on LSD. One focuses on Anxiety and the other one on cluster headaches.
Seelos Therapeutics (NASDAQ: SEEL) is currently undertaking a phase 2 trial looking at the efficacy of a proprietary ketamine intranasal device in the treatment of acute suicidal ideation and behavior (ASIB) in major depressive disorder.
Awakn Life Sciences
Awakn Life Sciences (NEO: AWKN) purchased IP for a phase 2 a/b trial using Ketamine for reduction of alcoholic relapse in a study led by Prof. Celia Morgan.
B.More is a non-profit life science company studying psilocybin to treat patients suffering from Alcohol Use Disorder. The NGO is currently pushing a phase 2 double-blind trial on patients with alcohol dependence.
Announced Phase 2 Trials
Aside from ongoing LSD trials, MindMed has also announced future phase 2 trials using LSD microdosing for attention deficit hyperactivity disorder (ADHD) and pain management.
Clinical-stage biotech DemeRx, which is part of Atai Life Sciences’ (NASDAQ: ATAI) portfolio, has completed phase 1 trials for noribogaine and is now planning to launch a phase 2 trial on a compound for the treatment of opioid abuse disorder.
In March, Cybin (NEO: CYBN) (OTCQB: CLXPF) received approval to commence a Phase 2 trial testing CYB001, a proprietary sublingual formulation of psilocybin for the treatment of the major depressive disorder.
Awakn Life Sciences
Later this year, Awakn plans to launch a phase 2b clinical trial to test the effectiveness of MDMA-assisted therapy for the treatment of alcohol use disorder, which will be led by Prof. David Nutt.
Eleusis has announced it expects to begin phase 2 trials on ELE-Ket+ and ELE-Psilo+; two psychedelic infusion therapies using Ketamine and Psilocybin, respectively, for the treatment of major depressive disorder by the end of 2021.
FIlament Health (NEO Exchange: FH) has a naturally-extracted psilocybin formulation called PEX010, which it expects to begin studying in phase 2 trials sometime before the end of 2021.
MAPS is also in preparations for a phase II trial to examine MDMA-facilitated cognitive-behavioral conjoint therapy (CBCT) as a treatment for PTSD in couples where one partner was diagnosed with PTSD.
Mydecine Innovations Group Inc. (NEO: MYCO) (OTCPINK: MYCOF) has received approval to conduct a phase 2 trial using psilocybin in combination with psychotherapy for the treatment of PTSD.
Phase 1/2 Trials
Dublin-based GH Research (NASDAQ: GHRS) has completed a phase 1 trial on GH001, an inhalable version of 5-MeO-DMT, proving safety and efficacy on healthy volunteers. The company has raised $125 million to fund a phase 1/2 trial on patients suffering chronic depression.
Small Pharma has teamed up with the Centre for Psychedelic Research at Imperial College London for a Phase 1/2a trial of DMT for the treatment of depression. A study on healthy volunteers has already begun recruiting and will use SPL026, an intravenous DMT formulation.
DemeRx announced in March it has received approval to begin recruitment for a Phase 1/2a clinical trial of ibogaine, using proprietary analog DMX-1002 in the treatment of opioid use disorder.
Ongoing Phase 1 Trials
Mind Medicine Inc’s extensive pipeline features several molecules in phase 1. The company is currently studying 18-MC, an ibogaine analog, in an ongoing phase 1 trial in healthy volunteers, which is expected to complete by December 2021. The main indication of the study is addiction disorder.
The company has also launched four other phase 1 trials in partnership with University Hospital Basel for undisclosed indications. These are researching DMT, mescaline, a combination of MDMA and LSD and lastly, ketanserin, a drug meant to stop the hallucinogenic effects of some psychedelic drugs by blocking the serotonin 5-HT2A receptor.
Perception, another company in the Atai Life Sciences portfolio, is studying PCN-101, an arketamine infusion, which will first be researched for safety and tolerability and then contrasted to esketamine in healthy volunteers.
The for-profit arm of the Beckley Foundation is recruiting for a phase 1 trial using psilocybin in the treatment of chronic short-lasting unilateral neuralgiform headache attacks.
Ceruvia is currently in clinical trials for two compounds: NYPRG-101 a non-hallucinogenic analog of LSD traditionally known as BOL-148, and SYNP-101, a synthetic form of psilocybin. Ceruvia, in conjunction with Yale University, is currently in phase 1 trials studying NYPRG-101 for migraine and cluster headaches, and SYNP-101 for those same indications, as well as obsessive-compulsive disorder.
Announced Phase 1 Trials
Eleusis has completed a phase 1 trial on ELE-LSD, a low-dose LSD formulation for the treatment of neurodegenerative diseases. The company has announced a second upcoming phase 1 trial on the same molecule.
Algernon Pharmaceuticals Inc. (Canadian: AGN) (OTCQB: AGNPF) has announced a phase 1 study on AP-188, a sub-hallucinogenic formulation of DMT, for the acute treatment of stroke victims. The trial is planned to start before the end of the year.
In 2020, Beckley Psytech raised over £17 million ($24 million) to fund a 5-MeO-DMT research program that will start with a phase 1 trial on healthy volunteers, due to launch before the end of 2021.
Entheon Biomedical Corp. (CSE: ENBI) (OTCQB: ENTBF) has announced a phase 1 trial analyzing intravenous DMT in the treatment of substance use disorders, which is set to start in the fourth quarter of 2021. The study will be done at the Centre for Human Drug Research in the Netherlands.
Non-profit Sacred Medicines is working on developing a phase 1a study using Ayahuasca in a clinical setting, for FDA approval.
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