FDA Green Lights Clinical Trial of Low-Dose Psilocybin
The FDA has cleared Diamond Therapeutics’ investigational new drug application for a clinical trial evaluating the effects of repeat low doses of psilocybin in patients with demoralization.
The trial, to enroll 60 participants, will evaluate the feasibility, efficacy and mechanisms of action of low doses of psilocybin in this indication. The study will be led by Peter Hendricks, a clinical psychologist and professor at University of Alabama at Birmingham.
The study builds on the results of a phase 1 clinical trial in Canada, which established a safe, tolerable, non-hallucinogenic dose range for the use of low doses of psilocybin on an outpatient basis.
Diamond is also launching a phase 2 clinical trial to investigate low-dose psilocybin’s efficacy in treating generalized anxiety disorder, which affects seven million U.S. adults. That study will be conducted in Canada on a take-at-home basis and has received Health Canada approval.
Diamond Therapeutics is a Toronto-based company founded in 2018. Their mission is to develop new and better drugs for mental health conditions by unlocking the promise of psychedelic compounds.
Starting with low-dose psilocybin, Diamond’s focus is on sub-perceptual, non-hallucinogenic treatments that hold potential for use across a broad patient cohort—maximizing the positive impact better drugs can have on the global mental health crisis.
World-leading management, board, and advisory with decades of experience in neuroscience, pharmacology, psychiatry, drug discovery, and pre-clinical and clinical neuropsychiatric drug development.
Exclusive worldwide partnership with established Canadian pharmaceutical manufacturer Dalton Pharma Services provides Diamond with independent access to cGMP psilocybin to support clinical trials and further research.
March 22, 2023
