Clearmind Medicine Obtains Clearance for its Psychedelic- Based Alcoholism Clinical Trial

Vancouver, Canada, March 13, 2024 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq, CSE: CMND), (FSE: CWY) (“Clearmind” or the "company"), a clinical- stage biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, announced that it has received approval from the Israeli Ministry of Health to commence its phase I/IIa clinical trial for alcohol use disorder (AUD) patients using the company's proprietary MEAI-based (5-methoxy-2-aminoindane) CMND-100 oral capsule. The approval, previously announced on February 23, 2024, allows Clearmind to start its pioneering clinical trial.

The clinical trial is a multinational, multi-center, single and multiple dose tolerability, safety and pharmacokinetic study of CMND-100 in healthy volunteers and AUD subjects. The Israeli study will be led by Prof. Mark Weiser, M.D., head of the Psychiatric Division at the Sheba Medical Center in the Tel Aviv suburb of Ramat Gan.

The company intends to have two additional sites in the United States for the phase I/IIa clinical trial, at the Yale School of Medicine’s Department of Psychiatry and the Johns Hopkins University School of Medicine.

"We are thrilled to receive approval to commence our phase I/IIa clinical trial for our lead drug candidate, CMND-100, which has been shown to be safe and effective in preclinical studies. This is the most important milestone for the company to date and marks our transition to a clinical- stage pharmaceutical company. The Clearmind team has been working tirelessly on the research and development of a novel treatment to the global epidemic of alcoholism. We are eager to continue our work with patients in need of help,” said Dr. Adi Zuloff-Shani, CEO of Clearmind Medicine. “We believe that our non-hallucinogenic, psychedelic solution could be the answer to the global need for dedicated and effective treatments for addictions."

The primary endpoint of the clinical trial is to find the tolerable dose and characterize the safety and pharmacokinetics/ pharmacodynamics of single and repeated doses of CMND-100 in healthy subjects and those with AUD. The secondary endpoint is to evaluate the preliminary efficacy of CMND-100 in reduction of drinking patterns and cravings in individuals with moderate-to-severe AUD. Oral capsules will be administered and subjects treated by these oral capsules will report their drinking patterns and cravings for alcohol during the clinical trial.