Diamond Therapeutics Announces FDA-authorized Clinical Trial of Low-Dose Psilocybin in Collaboration with University of Alabama at Birmingham

• The Investigational New Drug application (IND) for this trial has been cleared by the United States Food and Drug Administration (FDA)
  
  
• The study investigates the effects of repeat low-dose psilocybin on demoralization
  
  
• The trial will be conducted at the University of Alabama at Birmingham (UAB) under noted psychedelic researcher Dr. Peter Hendricks

TORONTO, March 21, 2023 /PRNewswire/ - 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 the FDA's authorization of the IND application submitted by collaborator Dr. Peter Hendricks. The FDA's authorization allows Dr. Hendricks to proceed with a human clinical trial evaluating the effects of repeat low doses of psilocybin in patients with demoralization.

The study will be conducted at the University of Alabama at Birmingham, with Dr. Hendricks, a noted psychedelic researcher, as principal investigator. Dr. Hendricks is a clinical psychologist and a professor at UAB's Health Behavior Department in the School of Public Health.

"This clinical trial will allow us to explore the therapeutic potential of low-dose psilocybin," says Dr. Hendricks. "We have only begun to understand how and when psilocybin might be beneficial to mental health, and I see this study as the first of many to come."

The trial will be a five-week, randomized, double-blind, placebo-controlled study. It will evaluate the feasibility, efficacy and mechanisms of action of low doses of psilocybin on patients with moderate to severe demoralization. Doses will be administered in a low range that will not produce mystical, transcendent, or hallucinogenic effects in subjects. As many as 60 patients will be enrolled.

"Dr. Hendricks is an internationally renowned researcher," says Judith Blumstock, Chief Executive Officer of Diamond. "This trial is a key milestone in Diamond's pursuit of low-dose, sub-perceptual, psychedelic-derived medicines that are safer and more effective for patients than the current first-line treatments."

The study builds on the results of Diamond's completed Phase I clinical trial, which was conducted under Health Canada regulation and established a safe, tolerable, non-hallucinogenic dose range for the use of low doses of psilocybin on an outpatient basis.

Diamond is also launching a Phase 2 clinical trial to investigate low-dose psilocybin's efficacy in treating generalized anxiety disorder (GAD), which affects seven million US adults. This Phase 2 study will be conducted in Canada on a take-at-home basis and has received Health Canada approval.

Further study details are listed on clinicaltrials.gov.

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.

Known for its innovative and interdisciplinary approach to education at both the graduate and undergraduate levels, the University of Alabama at Birmingham, a part of the University of Alabama System, is an internationally renowned research university and academic medical center with over $700 million in research awards annually, as well as Alabama's largest single employer, with some 28,000 employees, and has an annual economic impact exceeding $12.1 billion on the state. The pillars of UAB's mission include education, research, innovation and economic development, community engagement, and patient care. Learn more at www.uab.edu. 

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.