Earlier this month we discussed the emergence of overlap among psychedelics companies’ drug development pipelines. In the context of such overlap among the most popular indications (most of which are related to mental health ailments) we are now seeing companies announce remarkably distinct ones. This week, for example, PharmaDrug—who earlier this month revealed plans to investigate DMT for stroke—announced their intent to explore DMT in mitigating risks associated with kidney transplants (more below).
We should also expect to see new entrants on the molecule side of the equation, with new chemical entities (NCEs) an increasingly popular segment of research and development activity in the space.
While the diversification of target indications is surely in large part due to the broad range of ailments that psychedelics may be efficacious in addressing (anti-inflammatory agents, for example, have myriad applications), it is important to appraise the feasibility of any given indication. The same goes with NCEs: their value depends on their utility, such as their ability to treat a given ailment in a more efficacious, predictable, or safe manner. In short: not all NCEs are created equal, and not all indications are appropriate or realistic targets for psychedelic medicines.
In other news, NYU Langone Health officially launched its Center for Psychedelic Medicine, boosted by a $5m donation from MindMed. Investment in psychedelics companies continues to be forthcoming, exemplified by news today from Field Trip, who have increased their bought deal public offering to $83mm.
Psychedelic Sector News
DMT: the Key to a Safer Kidney Transplant?
DMT has been appearing in news releases across the sector, and news articles and videos across the media landscape, this month. Two weeks ago we covered the news that both Algernon Pharmaceuticals and PharmaDrug were hoping to target Stroke with DMT, and mainstream media outlets picked up on the former’s plans. Now, further indications are entering the fray.
This week, we learned that PharmaDrug is hoping to apply DMT in the prevention of ischemia reperfusion injury (IRI) in kidney transplant patients. The company expects that the anti-inflammatory properties of DMT, and the fact that it appears to activate the sigma-1 receptor, may mitigate damage caused by IRI, which is caused by sudden, temporary restriction of blood flow to an organ (in this case, the kidney).
Preclinical research in rats suggests this may be the case (e.g., Nemes et al., 2019). The company has filed for Orphan Drug Designation for this use case, as they did with DMT in Stroke.
Psilera Biosciences, meanwhile, has obtained DEA approval to study novel DMT and psilocybin treatments for CNS disorders. Through their collaboration with University of South Florida, Psilera will undertake research toward, among other programs, the development of a number of non-invasive delivery methods for DMT.
In other DMT-related news, Entheon Biomedical reported that their CRO, Science in Action, has received ethics approval for a planned pre-clinical study of DMT.
This flurry of R&D surrounding DMT provides a serendipitous context for the release of our latest resource, the DMT Patent Tracker. More below.
Awakn Shares MDMA for Alcohol Use Disorder Clinical Trial Update
UK-based Awakn Life Sciences announced the publication of results from an MDMA in alcoholism clinical trial, to which their CMO Dr. Ben Sessa contributed alongside a team of researchers including Dr. Laurie Higbed, David Nutt, and Steven O’Brien. The results were as follows:
MDMA treatment was well tolerated by all participants. No unexpected adverse events were observed. Psychosocial functioning improved across the cohort. Regarding alcohol use, at nine months post detox, the average units of alcohol consumption by participants was 18.7 units per week compared to 130.6 units per week before the detox. This compares favourably to a previous observational study (the ‘Outcomes’ study) by the same team with a similar population of people with AUD.
Our friends at Blossom have written a summary of this research.
The trial involved 14 participants, and was open-label. The company plans to progress this research into Phase IIb trials this year, in order to prove efficacy.
Publication of these results generated a great deal of media interest, particularly in the UK where the Daily Mail and The Times – both discernably conservative publications – covered the story.
NYU Langone Health Launches Center for Psychedelic Medicine, with >$10m in Funding
The Center will support research across three broad areas: psychiatry, medicine, and preclinical research. Donors include MindMed, who provided $5 million.
Philanthropic support from several donors totaling over $10 million will allow NYU Langone Health to advance its already world-renowned reputation in the field of psychedelic medicine through the establishment of a one-of-a-kind center dedicated to expanding research and professional medical training in this resurging field.
Financials, Financings and IPOs
Field Trip’s $83 million bought deal financing, which was upsized from $50mm, is the show-stopper round announced this week. Other notable rounds include Bright Minds’ $25m offering, and Red Light Holland’s round which closed at $11.6m raised.
We also saw a new pubco this week, with PsyBio completing their RTO and listing on the TSXV under ticker symbol PSYB.
Field Trip Upsizes Bought Deal: $50mm -> $83mm
Yesterday, Field Trip announced a $50mm bought deal public offering. Today, they announced the upsizing of that offering to $82,875,000. Units are priced at $6.50, a discount on the price of FTRP at close Thursday, which stood at $8.00. Today, FTRP trades lower.
PsyBio Begins Trading on TSXV
PsyBio Therapeutics began trading on the TSXV exchange, under ticker symbol PSYB, yesterday.
Novamind & Mindset Pharma Added to Psychedelics ETF
Both Novamind and Mindset Pharma were added to Horizons ETFs’ Psychedelic Stock Index ETF via their Fast Entry rule. Under this facility, the Index (which underlies the ETF) may add qualifying stocks to the ETF ahead of rebalancing schedules should the stock have a float marketcap >$50m (CAD).
Aion Therapeutic Closes $500k Round
Aion closed a $500k non-brokered private placement, with units priced at $0.075.
Bright Minds Announces $25m Offering
Vancouver-based Bright Minds Biosciences is offering 3.3m units at $7.57 each.
Red Light Holland Closes $11.6m Financing
26.45m units were priced at $0.44 each.
CBC Radio Airs 3-Part Series on Psychedelics
CBC’s The Current with Matt Galloway is airing three discussions pertaining to psychedelics for the treatment of mental illness. The first airing involves Dr. Evan Wood of Numinus; the second looks at ketamine-assisted therapy; and in the third and final airing of the series, Dr. Bruce Tobin discusses his work on anxiety and psilocybin. Listen here.
TVO Dedicates 30-min Segment to Asking: “Can Psychedelics Transform Mental Health Care?”
Guests discussed Health Canada’s Section 56 exemptions for psilocybin-assisted psychotherapy, and the promise of psychedelics for the treatment of mental health ailments. Representatives from MAPS and TheraPsil contributed to the conversation, which aired earlier this week. View the video here.
Stay Informed in 2021
We can only expect the rate of change and development in the psychedelic space to continue accelerating in 2021. Stay informed via our various platforms and channels…
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