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Diamond Therapeutics Announces Health Canada Approval of Phase 2 Clinical Trial with Low-Dose Psilocybin

The study will evaluate repeat low doses of psilocybin for safety, tolerability, and efficacy in treating generalized anxiety disorder (GAD) on a take-home basis, including an open-label follow-on extension.

TORONTO, Jan. 24, 2023 /CNW/ - Diamond Therapeutics Inc. ("Diamond"), a drug development company focused on low-dose psychedelic-derived therapies for use in the treatment of mental health, is pleased to announce it has received Health Canada approval to begin a Phase 2 clinical trial evaluating the safety, tolerability and efficacy of repeat low-doses of psilocybin for the treatment of generalized anxiety disorder (GAD). The approval comes by way of a No Objection Letter (NOL) from Health Canada.

Diamond Therapeutics Logo (CNW Group/Diamond Therapeutics Inc.)
Diamond Therapeutics Logo (CNW Group/Diamond Therapeutics Inc.)

According to Health Canada's clinical trials database, this is the first study to treat patients suffering from generalized anxiety disorder with psychedelics.

GAD affects 6.8 million adults annually in the US, or about 3.1% of the population, yet only an estimated 43.2% of them receive treatment. Patients with GAD experience considerable impairment and disability, similar to major depression, with which GAD often co-occurs. As a result, GAD is associated with a significant economic burden owing to decreased work productivity and increased use of health care services, particularly primary health care. Despite its prevalence and the need for treatment, few Phase 2 or later-stage clinical studies explore new treatments for GAD.

Diamond's trial is a four-week, Phase 2 randomized, double-blind study in adult patients with GAD with the potential for an additional four-week open-label extension. Patients will receive repeat low doses of psilocybin administered on a take-home basis. The study is among the world's first take-home clinical trials with psilocybin and one of the most comprehensive.

"Building on the results of Diamond's completed Phase I clinical trial, which established a safe, tolerable, non-hallucinogenic range for the use of low doses of psilocybin on an outpatient basis, this Phase 2 trial will explore the subjective and cognitive effects of low doses of psilocybin as well as effects on quality of life in adults who meet the criteria for GAD," says Dr. Michael B. McDonnell, Chief Medical Officer of Diamond.

"We are grateful for Health Canada's approval of Diamond's latest clinical trial application, which brings us closer to our goal of developing psilocybin-based medicines that are safe and effective for patients, that are better than the current first-line, and that may be prescribed on an outpatient basis, removing the barrier of lengthy time spent in a clinic," says Judy Blumstock, CEO of Diamond.

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.

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