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 80 mg and 160 mg doses respectively. The segment will assess safety, tolerability, and early signals of clinical activity, including CMND-100's potential to reduce 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 over five consecutive days in healthy participants, using a double-blind, placebo-controlled design.

"With the successful demonstration of safety and tolerability throughout the dose-escalation phase of the study, we are now positioned to evaluate CMND-100 in the population it is designated to help," said Dr. Adi Zuloff-Shani, Chief Executive Officer of Clearmind Medicine.

The multicenter trial is being conducted at Johns Hopkins University, Yale School of Medicine, Tel Aviv Sourasky Medical Center, and Hadassah Medical Center. The study is designed to evaluate safety, tolerability, pharmacokinetics, and preliminary efficacy in reducing drinking patterns and alcohol craving.

CMND-100 is an oral formulation of MEAI (5-methoxy-2-aminoindane), which Clearmind describes as a non-hallucinogenic compound intended to promote adaptive neuroplasticity. The information in this article is based on a press release issued by Clearmind Medicine.