Diamond Therapeutics Announces FDA-authorized Clinical Trial of Low-Dose Psilocybin in Collaboration with University of Alabama at Birmingham

Diamond Therapeutics Inc., a drug development company focused on low-dose psychedelic-derived therapies for use in the treatment of mental health, is pleased to announce the FDA’s authorization of the IND application submitted by collaborator Dr. Peter Hendricks. The FDA’s authorization allows Dr. Hendricks to proceed with a human clinical trial evaluating the effects of repeat low doses of psilocybin in patients with demoralization.

The study will be conducted at the University of Alabama at Birmingham, with Dr. Hendricks, a noted psychedelic researcher, as principal investigator. Dr. Hendricks is a clinical psychologist and a professor at UAB’s Health Behavior Department in the School of Public Health.

“This clinical trial will allow us to explore the therapeutic potential of low-dose psilocybin,” says Dr. Hendricks. “We have only begun to understand how and when psilocybin might be beneficial to mental health, and I see this study as the first of many to come.”

The trial will be a five-week, randomized, double-blind, placebo-controlled study. It will evaluate the feasibility, efficacy and mechanisms of action of low doses of psilocybin on patients with moderate to severe demoralization. Doses will be administered in a low range that will not produce mystical, transcendent, or hallucinogenic effects in subjects. As many as 60 patients will be enrolled.

The study builds on the results of Diamond’s completed Phase I clinical trial, which was conducted under Health Canada regulation and 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 (GAD), which affects seven million US adults. This Phase 2 study will be conducted in Canada on a take-at-home basis and has received Health Canada approval.

Further study details are listed on clinicaltrials.gov.

Diamond Therapeutics is a psychedelic drug development company based in Toronto. Our mission is to develop new and better therapies for mental health conditions by unlocking the promise of psychedelic compounds. Diamond is focused 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.