Clearmind Medicine's Psychedelic Alcoholism Trial Approved

Clearmind Medicine Inc. (Nasdaq, CSE: CMND), (FSE: CWY) (“Clearmind” or the "company"), a biotech firm at the clinical stage dedicated to developing innovative psychedelic-derived treatments for significant unmet medical needs, announced the Israeli Ministry of Health has greenlit its phase I/IIa clinical trial for patients with alcohol use disorder (AUD) using the company's unique MEAI-based (5-methoxy-2-aminoindane) CMND-100 oral capsule. This approval, shared on February 23, 2024, allows Clearmind to initiate its groundbreaking clinical study.

The trial is an international, multi-center examination of single and multiple dose tolerability, safety, and pharmacokinetics of CMND-100 in both healthy volunteers and AUD patients. The Israeli segment will be spearheaded by Prof. Mark Weiser, M.D., leader of the Psychiatric Division at the Sheba Medical Center in the Tel Aviv area of Ramat Gan.

Clearmind also plans to extend the phase I/IIa clinical trial to two additional locations in the United States, specifically at Yale School of Medicine’s Psychiatry Department and the Johns Hopkins University School of Medicine.

"We are elated to have received approval to commence our phase I/IIa clinical trial for CMND-100, a leading drug candidate demonstrated safe and effective in preclinical studies. This pivotal milestone advances us to a clinical-stage pharmaceutical company," stated Dr. Adi Zuloff-Shani, CEO of Clearmind Medicine. “Our dedicated team has been relentlessly focused on creating an innovative solution to the global alcohol abuse crisis. We are keen to continue our efforts to assist those desperately in need,” she expressed. “We believe our non-hallucinogenic, psychedelic treatment could address the global demand for effective addiction therapies."

The primary goal of the clinical trial is to discover the tolerable dosage and identify the safety and pharmacokinetics/pharmacodynamics of CMND-100 in both single and repeated doses for healthy subjects and those with AUD. Secondary objectives include evaluating the early effectiveness of CMND-100 on reducing alcohol consumption and cravings in individuals with moderate-to-severe AUD. Participants will take oral capsules and track their drinking patterns and alcohol cravings throughout the study.

The active component of CMND-100, MEAI, is a novel, psychoactive, non-hallucinogenic molecule noted for diminishing the urge to consume alcohol while offering a mildly euphoric alcohol-like effect. MEAI interacts with serotonergic receptors 5-HT1a and 5-HT2a, which are essential for regulating alcohol consumption, reward, preference, and dependency. It also affects alpha-2-adrenergic receptors α2A, α2B, and α2C, and the dopamine (DAT), norepinephrine (NET), and serotonin (SERT) plasma membrane monoamine transporters, which are thought to influence alcohol drinking behavior and could be vital targets for therapies against alcohol abuse.

About Clearmind Medicine Inc.

Clearmind is a clinical-stage psychedelic pharmaceutical biotech company focused on developing cutting-edge psychedelic-derived treatments to address prevalent and underserved medical issues like AUD. The company aims to research and develop psychedelic-based compounds and eventually commercialize them as regulated pharmaceuticals, foods, or supplements.

Clearmind's intellectual property portfolio consists of fifteen patent families and the company plans to seek additional patents for its compounds as necessary, while remaining open to acquiring more intellectual property to bolster its portfolio.

Shares of Clearmind are traded on Nasdaq and the Canadian Securities Exchange under the symbol "CMND" and on the Frankfurt Stock Exchange under the symbol “CWY.”