Diamond Therapeutics Announces First Patient Enrolled in FDA-authorized Study Evaluating Low-Dose Psilocybin in Human Subjects with Demoralization

2023-10-17

临床研究

The trial is being conducted at the University of Alabama at Birmingham (UAB) under noted psychedelic researcher Dr. Peter Hendricks

This exploratory study is the first investigation of the influence of low-dose psilocybin on human subjects suffering from demoralization

TORONTO, Oct. 17, 2023 /PRNewswire/ - Diamond Therapeutics Inc. ("Diamond"), a clinical-stage drug development company focused on non-hallucinogenic, psychedelic-based therapies for use in the treatment of mental health, today announced the enrollment of the first patient in an FDA-approved clinical trial conducted at the University of Alabama at Birmingham (UAB). The principal investigator is Dr. Peter S. Hendricks, a clinical psychologist and professor at UAB's Health Behavior Department in the School of Public Health. This study is referred to as the UAB-Diamond Trial.

Dr. Hendricks has published nearly 100 peer-reviewed manuscripts with 3,504 citations. His work has been recognized in media outlets, including National Geographic, The Economist, Business Insider, New York Times, Newsweek, U.S. News & World Report, Scientific American, Vogue, and Michael Pollan's bestseller, "How to Change Your Mind." Dr. Hendricks was recently named the first editor-in-chief of the journal Psychedelic Medicine, published by Mary Ann Liebert, Inc. He has provided keynote addresses on the topic of psychedelics nationally and internationally, including at the FDA and several other leading institutions.

The UAB-Diamond Trial will enroll 60 patients to evaluate the treatment of low doses of psilocybin in demoralization, which involves feelings of hopelessness and meaninglessness. The trial will assess initial signals of efficacy, feasibility, and potential mechanisms of action. Psilocybin will be administered across a series of low doses that are not expected to produce hallucinogenic or other subjective effects, which may limit broad use.

Demoralization is believed to be pervasive in the wake of COVID-19, resulting in a widely experienced unmet need for treatment. "This study is significant because it is the first to test low doses of psilocybin in the treatment of demoralization and is also among the first to test the effectiveness of low doses of psilocybin in a clinical rather than a healthy sample group," notes Dr. Hendricks.

Dr. William J. Tyler serves as a scientific advisor and Chief Technical Officer to Diamond, as well as professor at UAB's School of Engineering-Biomedical Engineering and head of the UAB's Alabama BRAIN Lab, although he is not actively involved in the UAB-Diamond study. Dr. Tyler says, "Diamond has achieved many notable milestones, including cellular studies, animal studies, and studies with healthy humans. Commencing the UAB-Diamond Trial is a landmark moment for Diamond and for the future of psychedelic medicine. The research community is keen to understand low-dose psilocybin's impact on a clinical population. It is our sincere hope that these efforts will help provide solutions to the mental health crises facing our nation."

Diamond Therapeutics

Diamond Therapeutics is a clinical-stage drug development company founded 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 take-at-home prescription 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

About UAB

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.

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.