2026-08-06SEC Filing 6-K (0001213900-26-086120)

On August 6, 2026, Clearmind Medicine Inc. announced that the independent Data and Safety Monitoring Board (DSMB) has unanimously approved the advancement of its ongoing FDA-regulated Phase I/II clinical trial for CMND-100. This approval follows the successful completion of Part A of the study, which evaluated the drug in healthy participants and met its primary safety endpoint, demonstrating a favorable safety and tolerability profile across all planned dose levels. The trial will now progress to Parts B and C. Part B represents a major milestone as it will evaluate CMND-100 for the first time in human patients with moderate to severe Alcohol Use Disorder (AUD), assessing safety, tolerability, and early clinical activity signals such as reduced alcohol consumption. Part C will concurrently evaluate a fixed daily dose in healthy participants over five consecutive days. CMND-100 is a proprietary oral formulation of MEAI, designed as a non-hallucinogenic neuroplastogen-derived candidate to treat addictions and weight management without the perceptual effects of classical psychedelics.

Ticker mentioned:CMND