Diamond Therapeutics Achieves Last Patient Last Visit in Clinical Trial of Low-Dose Psilocybin

TORONTO, March 29, 2022 /PRNewswire/ - Diamond Therapeutics Inc., a drug development company focused on non-psychedelic doses of psilocybin for use in the treatment of mental health, announces the completion of last patient last visit (LPLV) in its Phase 1 clinical trial of low doses of psilocybin. LPLV is the date upon which the last subject completes a clinical study. The study's final patient follow-up visit was March 12, 2022.

This randomized, double-blind trial is the first systematic, placebo-controlled, single ascending dose study to investigate very low doses of psilocybin in humans. The study assesses psilocybin's safety and tolerability. The aim is to identify an active, non-psychedelic dosage.

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

"Before this study, little proper, controlled research had been done to investigate very low concentrations of psilocybin," says Dr. Michael B. McDonnell, Chief Medical Officer of Diamond. "Diamond's study is robust and well designed with controls for bias and expectancy. It will advance our understanding of the therapeutic potential of very low doses of psilocybin."

The trial was conducted in Toronto under the supervision of principal investigator Dr. Isabella Szeto of BioPharma Services Inc., the contract research organization working with Diamond. Diamond anticipates topline results will be available by May 2022, with a complete analysis to follow.

"We look forward to sharing the study data as soon as all analysis is complete," says Judy Blumstock, Diamond's founder and CEO. "The results from this landmark trial will catalyze our planned phase two studies. We are closer to achieving our goal of bringing new and better accessible alternative therapeutics to the millions of people struggling with mental health disorders. "

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.