Clearmind DSMB Approves CMND-100 Trial Advancement

Clearmind Medicine Inc. (Nasdaq: CMND), a clinical-stage biotech company, announced that its independent Data and Safety Monitoring Board (DSMB) unanimously approved advancing its FDA-regulated Phase I/II clinical trial of CMND-100, a non-hallucinogenic neuroplastogen-derived candidate for Alcohol Use Disorder (AUD), to Parts B and C. The approval follows successful completion of Part A, which demonstrated a favorable safety and tolerability profile in healthy participants. Part B will evaluate CMND-100 for the first time in patients with moderate to severe AUD, enrolling two cohorts of six patients at 80 mg and 160 mg doses, assessing safety, tolerability, and early efficacy signals including reduction in alcohol consumption and craving. Part C, conducted concurrently in healthy participants, will evaluate a fixed daily dose of 160 mg over five days in a double-blind, placebo-controlled design. The trial is conducted at leading clinical sites including Johns Hopkins University, Yale School of Medicine, Tel Aviv Sourasky Medical Center, and Hadassah Medical Center. CEO Dr. Adi Zuloff-Shani highlighted the milestone as a meaningful step toward a potential new treatment for AUD. The company expects to provide further updates as enrollment progresses.