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

The trial is the first to identify a safe, active, non-psychedelic dosage of psilocybin. 

TORONTO, Dec. 7, 2022 /PRNewswire/ - Diamond Therapeutics Inc. ("Diamond"), 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. 

"The Diamond study assessed psilocybin's safety and tolerability with the aim of identifying a safe, well-tolerated, active, non-psychedelic dosage of psilocybin. Before this study, little, if any, controlled research had been done to investigate low doses of psilocybin," says Dr. Michael B. McDonnell, Chief Medical Officer of Diamond. "The study showed that low-dose psilocybin is well-tolerated with no adverse events that would preclude its usage on an outpatient basis at home, removing the barrier of lengthy time spent in a clinic."

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. To learn more about Diamond, visit www.diamondthera.com.

This news release includes certain "forward-looking information" under applicable Canadian securities legislation. Forward-looking information includes statements other than statements of historical fact that can be identified by phrases such as "expects", "anticipates", "intends", "aims", "plans" and "believes", and are based on expectations, estimates and projections as at the date of this news release. Forward-looking statements in this news release include, but are not limited to, the potential effects of low-dose psilocybin and other psychedelic treatments, the potential use in treating mental health conditions and the timing and completion of Diamond's clinical programs and trials. Forward-looking information is necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such factors include, but are not limited to: general business, economic, competitive, political and social uncertainties; delay or failure to receive applicable regulatory approvals; that factors may occur which impede Diamond's future business plans; the results of continued development, marketing and sales; and other factors beyond the control of Diamond. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking information. Diamond disclaims any intention or obligation to update or revise any forward-looking information in this news release, whether as a result of new information, future events or otherwise, except as required by law.

SOURCE Diamond Therapeutics Inc.