Diamond Therapeutics completes Phase I clinical study of low-dose psilocybin in healthy human subjects

Diamond Therapeutics Inc., a drug development company focused on low-dose psychedelic-derived therapies for use in the treatment of mental health, announces the successful completion of its Phase I clinical study of low-dose psilocybin. 

Regulated by Health Canada, Diamond’s study is the first randomized, double-blind, and placebo-controlled single ascending dose study to investigate low doses of psilocybin in human subjects. 

For the trial, fifty-six subjects were enrolled in seven separate cohorts over four and a half months. A panel of five physicians reviewed all safety data as it became available.

The study establishes a safe, tolerable dose range for the use of low, non-psychedelic doses of psilocybin, opening the possibility that future psilocybin-based medicines may be prescribed on an outpatient basis. 

Findings also demonstrate that low doses of psilocybin are psychoactive.

“The results from this landmark trial exceeded our expectations bringing us closer to achieving our goal of providing new, better and more broadly accessible therapeutics to the millions of people struggling with mental health disorders,” says Judy Blumstock, Diamond’s founder and CEO. “Based on these results, we are proceeding full tilt with our Phase II trial plans and anticipate sharing more news in the coming weeks.”

With the data generated from the Phase I study, Diamond is preparing to launch a Phase II trial investigating low-dose psilocybin’s efficacy in treating generalized anxiety disorder (GAD). An estimated 2.7% of U.S. adults experienced GAD in the past year, and an estimated 5.7% will experience GAD at some time in their lives.

This Phase II study will be conducted in Canada under Health Canada regulations.

Diamond Therapeutics is a drug development company based in Toronto, Ontario. 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 global mental health.