Clearmind's DSMB clears Phase I/II AUD trial to advance to next stages

Clearmind Medicine Inc. said on August 6, 2026 that its independent Data and Safety Monitoring Board had unanimously signed off on moving its ongoing FDA-regulated Phase I/II trial of CMND-100 forward into Parts B and C, the two remaining stages of a three-part study evaluating CMND-100 in patients with active alcohol use disorder and in healthy participants¹.

The clearance came after Part A wrapped up, in which CMND-100 met its primary safety endpoint, showing a favorable safety and tolerability profile across all dose levels tested in healthy volunteers¹. Based on that dataset, the DSMB unanimously recommended proceeding to Parts B and C under the previously approved protocol¹.

Part B will mark the first time CMND-100 is tested in people actually living with the disorder. The company said Part B will enroll two sequential cohorts of six patients each with moderate to severe AUD, at 80 mg and 160 mg doses, assessing safety, tolerability and early signs of effect on drinking and craving.¹ Running alongside it, Part C will test a fixed 160 mg daily dose over five consecutive days in healthy participants, in a double-blind, placebo-controlled design meant to further define the drug's safety and tolerability.¹

The trial is being run at multiple sites. It is a multicenter Phase I/II study assessing safety, tolerability, pharmacokinetics, and preliminary signs of efficacy on drinking patterns and alcohol craving in people with moderate to severe AUD, conducted at Johns Hopkins University, Yale School of Medicine, Tel Aviv Sourasky Medical Center, and Hadassah Medical Center.¹

CMND-100 is described as Clearmind's proprietary oral formulation of MEAI, or 5-methoxy-2-aminoindane¹. The company said it expects to provide further updates as enrollment and the program progress.¹