Diamond Therapeutics Announces Health Canada Approval for Phase II Clinical Trial with Low-Dose Psilocybin

The study will evaluate repeated 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, January 24, 2023 /PRNewswire/ — Diamond Therapeutics Inc., a drug development company focused on low-dose psychedelic-derived therapies for use in the treatment of mental health. 2 clinical trial evaluating the safety, tolerability, and efficacy of repeated low doses of psilocybin for the treatment of generalized anxiety disorder (GAD). Approval comes through a letter of no objection (NOL) from Health Canada.

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

This is the first study to treat patients suffering from generalized anxiety disorder with psychedelics, according to Health Canada’s clinical trials database.

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

The Diamond 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 be given repeated low doses of psilocybin, given on a take-home basis. This study is one of 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 low-dose use of psilocybin on an outpatient basis, this Phase 2 trial will investigate the subjective and cognitive effects of low will explore the effects of psilocybin dosage as well as quality of life in adults who meet criteria for GAD,” Dr. Michael B. McDonnellDiamond’s Chief Medical Officer.

“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 drugs that are safe and effective for patients, superior to current first-line , and which can be prescribed on an outpatient basis, eliminating the barrier of long hours spent in a clinic,” says Judy BlumstockDiamond CEO.

About Diamond Therapeutics

Diamond Therapeutics is a psychedelic drug development company based in toronto, Our mission is to develop new and better treatments for mental health conditions by unlocking the promise of psychedelic compounds. DIAMOND focuses on sub-conceptual, non-sedating therapies that have potential for use across a broad patient population—maximizing the positive impact of better medicines on the global mental health crisis. To know more about Diamond visit www.diamondthera.com,

Cautionary Statement Regarding Forward-Looking Information

This news release contains certain “forward-looking information” under applicable Canadian securities law. Forward-looking information includes statements other than statements of historical fact that can be identified by phrases such as “expects”, “anticipates”, “intends”, “objectives”, “plans” and “believes”, and is based on expectations , estimates and estimates as of the date of this news release. Forward-looking statements in this news release include, but are not limited to, the potential effects of psilocybin on low doses and other psychedelic therapies, its potential use in the treatment of mental health conditions, and the timing and completion of Diamond’s clinical programs and trials . Forward-looking information is necessarily based on a number of estimates and assumptions that, if deemed appropriate, are subject to known and unknown risks, uncertainties and other factors, which may cause actual results and future events to differ materially from those expressed or implied. Can be the reason. from such forward-looking statements. Such factors include, but are not limited to: general business, economic, competitive, political and social uncertainties; delay or failure to obtain applicable regulatory approvals; They may be factors that hinder Diamond’s future business plans; continued growth, marketing and sales results; and other factors beyond the control of Diamond. There can be no assurance that such statements will prove accurate, as actual results and future events may 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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SOURCE Diamond Therapeutics Inc.

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