The Pulse: Psychedelic News From Technology Networks Issue 2

Hello and welcome to the Pulse, the monthly psychedelics industry roundup from Technology Networks and Analytical Cannabis. Here, we’ll highlight some of the most significant psychedelic industry news from the past month, including important announcements, pre-clinical work and the latest from groundbreaking psychedelic clinical trials. Keep on the pulse of psychedelics and more by subscribing to our Breaking Science Newsletter below.

Highlights

One of the boldest forays into commercial ketamine clinics came to what looks like the end of its current journey this month as Field Trip Health announced the closure of five of its nine ketamine-assisted psychotherapy clinics and entered creditor protection ahead of exploring a possible sale. Based in Toronto, Field Trip offered online and in-person therapy options, but, blaming “financial constraints”, said it would shutter several clinics.

The stricken company also announced a number of layoffs, and the resignation of chief executive and chairman Ronan Levy. The company’s hybrid therapy offerings, which had previously relied on looser regulations around ketamine teletherapy, were paused in the wake of new rules that were likely to reduce access for potential clients.

Beckley Psytech announced that it had received investigational new drug (IND) approval for a Phase IIb study of its lead compound BPL-003 from the U.S. Food and Drug Administration (FDA).

BPL-003 is a synthetic, intranasal formulation of the psychedelic compound 5-MeO-DMT. In their new study, Beckley intends to assess the effects of a single medium or high dose of the compound in contrast to a sub-perceptual dose. The trial will take place in patients who are not taking concomitant antidepressants. The trial is notable as the first to receive FDA IND approval for a 5-MeO-DMT treatment.

Due to commence in the first half of 2023, the study will encompass 40 investigator sites across 7 countries.

In Brief

• Clearmind Medicine has filed three provisional U.S. patent applications for unique combinations of future psychedelic-based compounds as part of its ongoing collaboration with SciSparc. The patent applications refer to novel proprietary combinations of MDMA, ibogaine and ketamine, each in combination with palmitoylethanolamide (PEA), the active ingredient of SciSparc’s proprietary CannAmide™. This announcement adds to six other patients filed through the collaboration.
• Terran Biosciences has announced the publication of an international patent application covering novel prodrugs of psilocin, a metabolite of psilocybin and the active compound in psychedelic mushrooms. Terran is banking on these novel compounds to accelerate the action of psilocybin-assisted psychotherapy, which at present relies on six-hour-plus dosing sessions. Terran has also designed prodrugs with even longer durations of activity than psilocybin for extended therapy sessions.
• Biopharmaceutical company Cybin has announced progress updates for its two lead clinical development programs: a Phase I/IIa clinical trial of CYB003, its proprietary deuterated psilocybin analog for the treatment of major depressive disorder (MDD) and a Phase I trial of CYB004, a proprietary deuterated DMT molecule being developed for the treatment of generalized anxiety disorder. Cybin announced positive safety data from both studies and showed encouraging efficacy data from the trial of CYB003.
• Canadian psychedelics manufacturing firm Lucy Scientific Discovery has made its first commercial sale of psilocybin to the Center for Psychedelics Research at the Hadassah Medical Center at Hebrew University in Jerusalem. CEO Chris McElvany said that the sale marks “a key operational milestone.” The deal strengthens Lucy’s relationship with the Medical Center's researchers, to whom the company has already delivered DMT and 5-MeO-DMT in previous shipments.
• In further distribution news, Optimi Health Corp, a Canadian drug manufacturer and formulator, has signed a long-term distribution agreement with Mind Medicine Australia to supply its MDMA formulation, OPTI-MHCL, and GMP psilocybin capsules. Optimi is aiming to begin supply to Australia by the deadline of July 1, 2023, when authorized psychiatrists can begin prescribing MDMA and psilocybin for specific mental health conditions through the country’s newly approved Authorised Prescriber’s Scheme.
• And what would be a newsletter about a rapidly growing industry without some reports of internecine squabbles? Reunion Neuroscience has filed a lawsuit against fellow clinical-stage biopharma Mindset Pharma. The suit alleges that Mindset copied Reunion’s compound, RE104 and submitted its exact composition to the Patent Office. Reunion seeks to add its Chief Scientific Officer, Nathan Bryson, as an inventor to Mindset’s patent. Stay tuned to see how this latest psychedelic lawsuit develops.