This Week:
- š³ Coming soon: COMPASS Pathwaysā facility among a 200 acre woodland
- š A Psychedelics IP to-do list
- š The latest public āpsychedelicsā company to flounder
- š¼ Disturbing footage emerges from MAPS trial
ā¦and more. Letās get to it.
Psychedelic Sector News
COMPASS Partners with NHS and Kingās College to Launch Centre for Mental Health Research and Innovation in UK
Yesterday, COMPASS Pathways announced that it has formed a long-term partnership to launch The Centre for Mental Health Research and Innovation āto accelerate psychedelic research and develop new models of care for mental health in the UK.ā
COMPASS will work with the South London and Maudsley NHS Foundation Trust (SLaM) and the Institute of Psychiatry, Psychology and Neuroscience (IoPPN) not only to accelerate research into psychedelic therapies, but also to support therapist training and certification, the evaluation of real-world evidence and the prototyping of digital technologies to enable āpersonalised, predictive and preventative care models.ā
COMPASS announced this collaboration last summer, but yesterdayās news adds colour to the scale of the partnership, including plans for a state-of-the-art facility to be built āwithin a 200 acre woodlandā at Bethlem Royal Hospital, London. The company hopes this facility will host late-stage clinical trials, and provide access to COMP360 psilocybin therapy to āan estimated 650-700 patients over a five-year term.ā
Artefact of the Week: The Handover List from COMPASSā IP Chief
Our Editor-at-large Graham Pechenik shared an interesting to-do list on Twitter this week, but it wasnāt his own.
Rather, it was that of Nate Poulsen, who was signing a Transition Agreement with COMPASS Pathways last year.
Poulsen joined COMPASS in 2019 as General Counsel and Chief Legal Officer, transitioning to an interim role of Chief Legal Officer, IP in August 2021 until December when ex-Novartis Matthew Owens replaced him.
Exhibit A in the filing outlines a number of IP projects to be finished or handed-over by December last year, as well as a list of ongoing applications and prosecution.
Pechenik matched-up some of the more interesting projects mentioned (including benzos to increase sensitivity to psilocybin following chronic SSRI use and āsynaptic pathway trainingā) with links to further information.
h/t: Matt Ribel stumbled across this interesting artefact in an SEC filing directory. You can explore the full directory here.
Core One Labs Becomes Latest Psychedelics Company to Flounder
Days after MINDCURE’s announcement that itās effectively ceasing operations (read our analysis), Core One Labs becomes latest psychedelics company (loosely-defined) to flounder.
Core One Labs announced that itās looking to āinvestigate soliciting investment and potential takeover opportunities.ā Our data showed this was a ticking time bomb, and the companyās leadership doesnāt exactly have a stellar track record.
āAcquisition or investment by a major pharmaceutical company could be mutually beneficial,ā said CEO Joel Shacker in a statement that is, at best, optimistic; at worst, misleading.
But, thatās not the first time Shacker has made incredibly optimistic or unrealistic claims: last March, the company applied for a NASDAQ listing. Core One Labs (CSE: COOL) has a market cap of around CAD $30m.
The company also has a dizzying number of subsidiaries, with around 10 at the time of its last filings in fall 2021.
Itās certainly going to be a year of consolidation on the psychedelic public markets (note: weigh-in on our Twitter poll).
Other Company News
- Awakn closes $3.25m private placement;
- Cybin announces Adelia milestone achievement; sponsored feasibility study using Kernel Flow tech begins recruitment;
- Filament HealthĀ announces second patent issuance;
- Tryp Therapeutics initiates enrollment for binge eating study.
Weekend Reading
Disturbing Footage from MAPS Trial Emerges
Warning: the footage in the article linked below contains testimony of sexual abuse and scenes of traumatic events.
Power Trip, a series of New York magazineās Cover Story podcast (co-produced with psychedelics industry watchdog and critical voice Psymposia) reached a crescendo this week. The latest episode of the series was accompanied by the publication of footage depicting Meaghan Buissonās experience as a MAPS trial participant. It is disturbing to say the least.
The footage shatters the imagery of a āpeaceful, formal arrangementā that is so often portrayed by companies working in the space.
The accompanying article begins:
Much of the footage in this video looks like it comes from a security camera because it kind of does. Itās from a camera fixed to the wall of a treatment room, part of a routine medical setup. At the start of the video, you see a man adjusting the camera angle. The footage was supposed to be checked by professional monitors, who, if they saw it, might have asked some obvious questions: Why is this woman screaming? What are they doing in bed? Why is he using that soft doctor voice to tell her to spread her legs?
Many are asking questions of MAPS, including those around how timely and comprehensive the monitoring of such footage is. If a therapy session is recorded but the footage isnāt review in a timely or comprehensive fashion, is it really being monitored in a meaningful sense of the word?
Below, we share some notes on peopleās responses to the footage (including MAPSā)ā¦
Instead of using our platform to spout our own opinions, weāre curating a handful of reactions on Twitter:
- āCover Story #PowerTrip was extremely difficult to listen to. I hope it can create the momentum for a more careful and nuanced investigation of psychedelics’ potential for therapeutic benefit as well as for harm.ā – @chiaracap
- ātherapists have no reason to touch their clients in this wayā – @avadaei_
- āIām a full supporter of good psychedelic science, but I am NOT a full supporter for harmful and unethical behavior thatās being passed off as a ācure allā for PTSD and other neuropsychiatric disorders.ā – @JasterAlaina
- āIn what universe could someone watch this video and say āyep, looks great ā very ethical!ā?ā ⦠āI have to believe that this immediacy and power of this video is going to make an impact.ā – @ThomasVarley
- āVERY disturbing.ā – @eturnermd1 (Erick Turney was formerly a reviewer of psychiatric drugs at FDA, and has since become a staunch critic of what he deems to be the agencyās increasing rates of corporate capture by Pharma. His work to increase transparency in medical research has led to some influential publications, including this one that we cited in an earlier Bulletin: Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy ā Turner et al., 2008).
Ā
While most responded with horror, a minority responded with scepticism:
- Twitter user @calleymeans is promoting a theory that New York Magazine, along with Psymposia, is ādirectly funded by pharma companies,ā and that this is a campaign with the āexplicit goal of muddying the waters⦠cherry picking one patient from thousands to paint a (wrong) narrative.ā In short, he describes this series as āpharma-funded propaganda.ā We contest that anyone who knows the folks at Psymposia will deem this an absurd supposition.
- Another Twitter user, @HighRollHeros, expressed a similar āconcernā that Psymposia are āa Trojan horse full of bad faith prohibitionists acting as legalizers trying to create tabloid hysteria that damages the legalization movement more than helps it.ā Again, this is entirely unfounded.
Weāre with @maraldy on this one: āItās incredibly disheartening to see the stories being covered by @psymposia be described as sensationalist & gossipy. These are humans who were hurt, actual accounts of harmā¦ā Ā
Ā
MAPS Responds
MAPS has responded to Cover Storyās series in an article titled, Participant Experiences & āCover Story,ā published on its website.
Responding directly to the ethical violations depicted in the video and accounts of Buisson, they write that āMAPS views these violations as a breach of trust between patient and clinician and a violation of the MAPS Code of Ethics.ā
Yensen and Dryer, the trial investigators in the video, were previously removed as investigators of MAPS-sponsored trials āfor not complying with MAPS PBCās requirements for providing study records in a timely and organized fashion.ā
MAPS went on to explain that data from this trial site will not be submitted to the FDA, and that the ethical violations āwere reported to the FDA, Health Canada and the Institutional Review Board when MAPS was informed that an ethical violation had been committed.ā
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Potential FDA Repercussions?
Toward the end of the latest episode the showās hosts revealed that a 30-page complaint was submitted to FDA some months ago, outlining what they deemed to be ethical and research issues with MAPSā MDMA-AT for PTSD trials.
The hosts were disappointed by FDAās response, which came shortly after the airing of Episode 7; months after the complaint was filed. FDA explained that they had engaged in a workshop which included MAPS, but they werenāt willing to comment further.
How might the FDA respond to these accusations and revelations? Not just to this issue of sexual abuse, but also on the heterogeneity of the therapy administered alongside MDMA, and other allegations of methodological shortcomings.
BrainFutures Publishes Report Summarizing Clinical Evidence Surrounding Psychedelics
The nonprofit BrainFuturesĀ has published an extensive report summarizing the clinical evidence surrounding psychedelics as potential treatments for mental health and substance use disorders.
A member of the BrainFutures team explained to us:
The paper takes a sober look at the clinical research to date and makes recommendations for adoption of some of these compounds as mainstream treatments for conditions like PTSD and treatment-resistant depression (once approved by the FDA). Our research looks at seven different psychedelics (psilocybin, ketamine, MDMA, LSD, DMT, ibogaine, and mescaline) and categorizes the clinical evidence for each by condition (depression, anxiety, opioid use disorder, etc.) We believe this is the most comprehensive summary of research on psychedelics as a class that currently exists. We think it will be a fantastic advocacy tool for companies, organizations, and advocates working in this space as they continue to make the case for psychedelics.
Highly Recommended: Lecture Recordings from Stanfordās Introduction to Psychedelic Medicine Course
We love this: Stanfordās Boris Heifets (who has contributed to Psilocybin Alpha a number of times) has shared a number of lectures from a course he co-leads at Stanford (alongside Patricia Suppes and Gianni Glick): PSYC 215: Introduction to Psychedelic Medicine.
Check out this Twitter thread to find links to some of the lectures, which include guest lectures from Robin Carhart-Harris, Briand Anderson, Jennifer Mitchell, and Matt Baggott.
Three cheers for increasing access to world-class education!
Other things weāre reading:
- The Nation published a Special Issue dubbed Psychedelics Inc. Two pieces led the pack: Zoe Cormierās critical piece on which suggested that readers āget ready for Psychedelics Inc.ā, and AĆda ChĆ”vezās article on the ongoing legalization and decriminalization efforts unravelling across the states.
- An interview with Bryan Roth, who received a $27m grant from the federal government to research non-hallucinogenic psychedelics.
- Psychedelics researcher David Erritzoe speaks to Kinfolk about the āmind-bending potential of psychedelicsā, and shows of his wardrobe(!)
- The New York Times reminds us that the surge in demand for toad-derived 5-MeO-DMT is not without consequence.
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