Psychedelic Bulletin #146: Numinus Drops Lab, Consolidates Clinics; Study Suggests DMT Safe and Effective Alongside SSRI; Preprint Calls Intracellular Theory of Psychedelic-induced Neuroplasticity Into Question; A Cole Memo for Psychedelics? – Psychedelic Alpha

💸 GlobalData forecasts $7.2bn psychedelic drug market in 2029. The company shared the projection earlier this week, but it looks a little off. For starters, the three drug candidates they have identified as the leads don’t include MAPS PBC’s MDMA-AT or COMPASS’ psilocybin product… the de facto lead candidates of the segment.

💼 MAPS PBC is hiring for important roles as it gears up for potential approval and commercialisation of MDMA-assisted therapy. Earlier this month we reported on the publication of MAPS’ second Phase 3 study of MDMA-assisted therapy for PTSD, which reported positive results and paved the way for a New Drug Application to FDA. Recently, MAPS PBC posted a number of associated job listings, including Brand Lead and Head of Marketing as well as Head of Market Access. (This is a good opportunity to remind you to subscribe to job alerts, or create a profile, on our psychedelic job board.)

📃 Gilgamesh Pharma wraps Phase 1 trials of oral NMDAR antagonist, GM-1020. Last week, New York-based Gilgamesh announced that it has completed its Phase 1 Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) trials for GM-1020. The company argues that the candidate “distinguishes itself from existing ketamine-based therapies through its convenient oral formulation” as well as “expected efficacy at non-dissociative doses”, among other things. The company will share more information at ACNP in December and intends to initiate a Phase 2a study in MDD during H2’23.

🏫 Transcend and Yale score $1m grant from DoD. Yale University has received a three-year, $1m grant from the U.S. Department of Defense to support preclinical research geared towards uncovering the neurobiological mechanism driving MDMA and methylone’s apparent therapeutic effects in PTSD. In a press release (which did not mention MDMA), Transcend CEO Blake Mandell said that the research “will provide invaluable data on the neuroplastic effects of methylone on the brain.” The company also announced that its UK clinical trial, IMPACT-1, is underway, with topline data from the open-label element (N=15, severe PTSD patients) expected by year end. From there, the company intends to launch a randomised phase, enrolling up to 64 PTSD patients.

🧑‍⚖️ Krystal and Yale settle ketamine patent claims with VA. Yale was also in the news last week as a settlement came to light between the University and its professor John Krystal, and the VA. The Government had accused Yale and Krystal of withholding patent royalties related to the use of ketamine in the treatment of depression, which netted over $3m in royalties since 2015 via agreements with J&J’s Janssen (which markets SPRAVATO) as well as the Mount Sinai School of Medicine. Krystal and Yale will pay $1.5m to settle, with Connecticut U.S. Attorney Vanessa Roberts Avery noting that the settlement “shows our commitment to ensuring that the government is fairly compensated for all taxpayer funded inventions.” More via Reuters.

📖 BrainFutures publishes guide to reimbursement coding for PATs. Our friends at BrainFuture have published a guide to coding for psychedelic-assisted therapy practitioners. The guide also includes printable ‘cheat-sheets’, which should help providers “navigate the complex landscape of reimbursement for psychedelic-assisted therapy, regardless of the drug used.”

✋ Take Part in a Survey: naturalistic psychedelic use in the U.S. Long-time reader Nicolas Glynos, a postdoctoral researcher at University of Michigan, reached out to us about their survey study that seeks to better understand naturalistic psychedelic use in the U.S. If you have a moment, you can learn more about the survey and participate (anonymously) here.

📜 Tactogen wins its first patent grant for MDMA derivatives. Earlier this week, Palo Alto-based Tactogen announced that the USPTO has granted U.S. patent 11,767,305 covering “novel MDMA derivatives useful for the improvement of mental health”. CEO Matthew Baggott said that the company hopes the candidates they’re developing will “minimize unwanted effects while fully retaining the unusual therapeutic magic of MDMA”. The press release contains some great explainers on the benzofurans the company is working on, including some rationale.

🧮 Some sobering insights from Carbon Health’s Chief Product Officer (emphasis ours): “My hypothesis is that innovations in reimbursement, operations, or patient acquisition correlate more highly with success, than clinical innovations do. This is kind of a depressing thought. It means that, even if you discover an approach with better clinical outcomes for patients (and that is all you have), unless you also have figured out the economics in advance, you’ll likely be out of business before payors adopt it (because there’s no actual urgency for them to adopt it).” More here.

🗳 House Rules Committee advances psychedelic research amendments in appropriations bills. Two Republican-led, psychedelics-related amendments to a DoD funding bill were passed by the committee. One would appropriate $15m for DoD-led clinical trials of psychedelics, while the other would see the Defense Health Agency submit a report to Congress on how to ensure active-duty service members with PTSD and TBI can participate in VA clinical trials of psychedelics. The amendments will now head to the floor. Marijuana Moment has the details. (Update: both amendments were adopted by House votes.)

📆 Waitlist continues to grow at Oregon’s first psilocybin service centre. “Despite us being a very small service center, this week we have now served over 25 clients”, EPIC Healing Eugene’s founder Cathy Rosewell Jonas said in her latest newsletter update. The service centre’s waitlist is now over 5,000-long, she added, noting that “[w]e’ve decided to not go in order, but rather look for those ready to embark on a deep healing journey.”

🏫 UW Madison Psychedelic Symposium returns November 2-3. The third annual Symposium will highlight “community engagement approaches, scientific and clinical work being performed in this field at the UW-Madison, as well as featuring nationally renowned keynote speakers.” More info and registration.

⚖️ MindMed is suing 21-year-old Jake Freeman et al. over proxy bid. More via Bloomberg Law.

🚓 Detroit ‘psychedelic church’ raided by police; Shroomyz psychedelic dispensary born again in Kingston, ON. The game of Whac-A-Shroom continues as psychedelic dispensary Shroomyz opened a location in Kingston, Ontario, earlier this month. A ‘psychedelic church’ in Detroit, meanwhile, was raided by police this week, supposedly because of the use of psilocybin mushrooms.

🧑‍⚕️ Survey shows American psychiatrists increasingly open to psychedelic therapies. A 7-year follow-up survey by Barnett et al. (2023) found that, versus a 2016 survey, American psychiatrist respondents showed “significantly increased optimism regarding the therapeutic promise of hallucinogens and decreased concern about risks, with 50.4% of respondents reporting moderate/strong intentions to incorporate hallucinogen-assisted therapy into their practice.” We’re working on a longer piece about various groups’ perceptions of psychedelics. More to come.

🤕 University of Toronto researchers score $100k grant to study psilocybin for chronic neuropathic pain. The early-career collaborative grant was awarded to Dr. Ishrat Husain and Dr. Karim Ladha for an open-label, proof-of-concept study in 10 adults with chronic neuropathic pain and comorbid MDD.

🏥 UK Drug Policy: first drug consumption room given go-ahead in Glasgow. The pilot scheme will open in Glasgow and hopes to run for an initial period of three years at a cost of £7m ($8.5m), funded by the Scottish government. Indeed, it’s not something the current UK government would fund, and the decision by Glasgow authorities to green-light the facility demonstrates a growing rift between Scottish and UK drug policy. The Scottish Nationalist Party earlier called for the decriminalisation of possession of drugs, which was rejected by the UK government. In response to this latest development, the UK Home Office told the BBC that “there is no safe way to take illegal drugs”.