Clinical Trials
Biotech firm MindMed has begun enrollment in a Phase 1 clinical trial involving the psychedelic DMT, a key ingredient in the ceremonial brew ayahuasca. The DMT trial will assess the safety, tolerability, and dose response of the DMT in 30 healthy subjects in a randomized 5-period crossover, double-blind, placebo-controlled design.
MindMed is investigating the psychedelic as a potential drug candidate due to the advantages its short duration offers compared to other psychedelics such as psilocybin and LSD. The study will also assess intravenous administration methods for DMT as well. The DMT trial is led by Dr. Matthias Leichi as part of MindMed’s ongoing collaboration with the University of Basel Liechi Lab, in Switzerland.
“Currently no study has validly determined the elimination half-life of DMT or other pharmacokinetic parameters and our study will provide valuable information for future research on DMT as a tool to examine alterations of the mind,” said Dr. Miri Halperin Wernli, Executive President of MindMed.
Expansions
Novamind Inc., is opening New Clinic, an integrative psychiatric and clinical research clinic in Draper, Utah, to serve as a referral center for clients seeking psychedelic-assisted therapy for treatment-resistant mental health conditions including depression, eating disorders, post-traumatic stress disorder (PTSD), and obsessive-compulsive disorder.
With the opening of the Draper, Utah clinic, Novamind is on track to open four new locations in the state by September 2021, doubling the size of its network of clinics. The company anticipates expanding to other states by the end of 2021 through strategic acquisitions and organic growth.
“We are on a mission to reduce suffering and optimize wellness and are committed to shaping the future of psychedelic medicine in a responsible and accessible way,” says Dr. Reid Robison, Novamind’s Chief Medical Officer. “With traditional mental health treatments proving ineffective for too many, we look forward to providing psychedelic-assisted psychotherapy at the Draper clinic for treatment-resistant conditions.”
Manufacturing
Filament Health Corp., has been granted an amendment to its existing Health Canada Dealer’s License enabling the company to possess, produce, research, supply, export, import, and deliver all remaining controlled natural psychedelic substances including N,N-dimethyltryptamine (DMT), mescaline, and others.
The company’s previous license only allowed such applications for psychoactive mushrooms. Filament hopes to create the first-ever natural pharmaceutical grade extracts of these substances and enter them into clinical trials to demonstrate their safety and efficacy.
“This license amendment significantly increases the scope of our work with natural psychedelics,” says Ryan Moss, Filament’s director of research. “By studying untapped psychedelics in a scientific setting, we believe we can unlock and standardize their healing power. This is a promising step forward in our mission to get safe, natural psychedelics into the hands of everyone who needs them, as soon as possible.”
Mind Cure Health has launched the second stage of manufacturing pharmaceutical grade ibogaine to be used in clinical research. The company will be assessing the quality, timing, and cost of the synthetic psychedelic when produced at scale for commercial-scale manufacturing.
“We are now one step closer towards our goal of manufacturing synthetic ibogaine at a commercial scale for research purposes,” says Kelsey Ramsden, President and CEO of Mind Cure. “We are currently working on proving the ability to scale up the production, and our next step will be to test the ibogaine to ensure it meets the highest standards of pharmaceutical grade product.”
Partnerships
Havn Life Sciences Inc., a biotech firm pursuing standardized extraction of psychedelic compounds for brain health, stuck a deal with Kingston, Jamaica-based P.A. Benjamin Manufacturing Company (PAB) to facilitate the export of Havn Life’s naturally-derived psilocybin from Jamaica to the U.S., Canada, and Europe.
The strategic partnership, along with Havn Life’s collaboration with Jamaican food and psychoactive mushroom producer Hypha Wellness, puts Havn Life in a sweet spot to provide psychedelics to companies seeking high-quality and naturally derived psilocybin when regulations surrounding psychedelics begin to loosen around the world.
