Clearmind Medicine Inc. (Nasdaq: CMND) announced that its independent Data and Safety Monitoring Board (DSMB) has unanimously approved advancing its FDA-regulated Phase I/II clinical trial of CMND-100 to Parts B and C, which will include patients with Alcohol Use Disorder (AUD) for the first time.

The approval follows the completion of Part A of the study, in which CMND-100 met its primary safety endpoint, demonstrating a favorable safety and tolerability profile across all planned dose levels in healthy participants.

Part B will enroll two sequential cohorts of six AUD patients each, receiving doses of 80 mg and 160 mg respectively. The segment will assess safety, tolerability, and early signals of clinical activity, including potential reductions in alcohol consumption and craving in patients with moderate to severe AUD.

Part C will run concurrently with Part B and will evaluate CMND-100 at a fixed daily dose of 160 mg administered over five consecutive days in healthy participants. This double-blind, placebo-controlled segment is intended to further characterize the drug's safety and tolerability profile.

"Receiving DSMB approval to advance our clinical trial to patients with AUD marks an important milestone for Clearmind," said Dr. Adi Zuloff-Shani, Chief Executive Officer of Clearmind Medicine.

The trial is being conducted at Johns Hopkins University, Yale School of Medicine, Tel Aviv Sourasky Medical Center, and Hadassah Medical Center. CMND-100 is an oral formulation of MEAI (5-methoxy-2-aminoindane), which the company is developing as a non-hallucinogenic candidate intended to promote neuroplasticity.