Diamond Therapeutics Announces First Patient Dosed in Clinical Trial Evaluating Low-Dose Psilocybin

World's first systematic, pharmacokinetic/pharmacodynamic study of non-psychedelic doses of psilocybin

TORONTO, Nov. 8, 2021 /PRNewswire/ - Diamond Therapeutics Inc. ("Diamond"), a drug development company focused on non-hallucinogenic, psychedelic-based therapies for use in the treatment of mental health, today announced the dosing of the first cohort of its Phase 1 clinical trial. The trial is evaluating the safety and tolerability of low dose, non-hallucinogenic psilocybin in healthy volunteers.

"This trial will allow us to identify a safe and non-hallucinogenic dose of psilocybin. The results will help inform future clinical trials to evaluate psilocybin's potential for treating mental health disorders," says Dr. Edward Sellers, Professor Emeritus, Pharmacology and Toxicology, Medicine and Psychiatry at the University of Toronto and Chair of the Scientific Advisory Board for Diamond Therapeutics. "We plan to thoroughly evaluate the potential of low-dose psilocybin through a rigorous clinical trial program and believe that this is just the beginning," adds Dr. Sellers.

The randomized, double-blind Phase 1 trial is the first systematic, placebo-controlled, single ascending dose pharmacokinetic/pharmacodynamic study of very low doses of psilocybin in humans. It is designed to assess safety and tolerability. The trial is being conducted in Toronto under the supervision of principal investigator Dr. Isabella Szeto of BioPharma Services Inc., the contract research organization working with Diamond. It will assess up to 80 subjects with escalating doses of psilocybin. 

Diamond Therapeutics' non-human research study published in the journal Frontiers in Pharmacology earlier this year demonstrated that very low, non-hallucinogenic doses and concentrations of psilocybin and its metabolite psilocin can enhance motivation and attention. Diamond believes this indicates a potential for therapeutic use in treating psychiatric disorders, including anxiety and depression. The study was the first to rigorously evaluate low doses of psilocybin and show that hallucinogenic effects are not needed for potential therapeutic benefits.

In the U.S., one in five adults experiences mental illness each year. The economic cost is also high, approximately $225 billion in 2019. Novel therapeutic options are needed to help alleviate these burdens and address unmet needs in the treatment of mental health disorders.

"We are pleased to have begun assessments of low doses of psilocybin in human trials and are optimistic the results from this study will provide the data necessary to advance rapidly to later-stage studies," says Dr. Michael McDonnell, Chief Medical Officer of Diamond.

"This is a significant milestone for Diamond and, potentially, for the future of mental health treatment," adds Judy Blumstock, CEO of Diamond. "We have a strong clinical research team who are focused on unlocking the full potential of low dose psilocybin in treating psychiatric disorders, and in a way that is affordable and accessible to patients."

About Diamond Therapeutics
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.

Cautionary Statements Regarding Forward-Looking Information
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.