Diamond Therapeutics Announces Health Canada Approval of Clinical Trial with Low-Dose Psilocybin

TORONTO, Aug. 17, 2021 /PRNewswire/ - Diamond Therapeutics Inc. ("Diamond"), a drug development company focused on low-dose psychedelic therapies for use in the treatment of mental health, is pleased to announce that it has received a No Objection Letter from Health Canada, allowing Diamond to proceed with a human clinical trial to evaluate low doses of psilocybin in healthy volunteers.

The trial is a Phase 1 randomized, placebo-controlled, double-blind study to evaluate the safety and pharmacokinetics of low doses of psilocybin in as many as 80 study participants.

According to Health Canada's clinical trials database, to date, there are only two other Canadian clinical trials involving psilocybin.

"We are grateful to Health Canada for their support of this groundbreaking study," says Judy Blumstock, CEO of Diamond. 

The study will build on the results of previous animal research conducted by Diamond that demonstrated for the first time that certain, low, non-hallucinogenic doses of psilocybin hold potential for therapeutic use. Diamond believes these findings may help unlock the use of low-dose psilocybin to treat psychiatric disorders, including anxiety and depression. 

"This upcoming clinical trial will enable Diamond to gain critical clinical information that will help inform future human trials with psilocybin and other pipeline compounds," says Dr. Edward Sellers, chair of Diamond's scientific advisory board.

Diamond is also planning to launch a Phase 2 trial to investigate low-dose psilocybin's efficacy in treating anxiety, which is the most common mental health disorder in the U.S., causing moderate to severe disability in over 50% of sufferers. This Phase 2 study will be conducted in both Canada and the U.S.

As well, Diamond plans to support an investigator-led study of low-dose psilocybin in the U.S. to explore its effects on patients with moderate depression.

"We're very excited to commence our clinical program. It brings us one step closer to creating therapeutics that can help more people access effective and safe treatments for mental health conditions," says Ms. Blumstock.

"It's because of the hard work of our team, partners and advisors that we've been able to achieve this significant milestone," she says.

Note:
The safety and efficacy of psilocybin for any indication has not yet been established.

About Diamond Therapeutics
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. 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.