CMND-100

August 6, 2026: Clearmind Medicine Inc. (NASDAQ: CMND) said its independent DSMB unanimously approved advancing the FDA-regulated Phase I/II trial of CMND-100 into Parts B and C after Part A met its primary safety endpoint in healthy participants, with favorable safety and tolerability across all planned dose levels.

CMND-100, an oral MEAI (5-methoxy-2-aminoindane) formulation, is being developed for alcohol use disorder (AUD). Part B will be the program’s first evaluation in patients with moderate to severe AUD, enrolling two sequential cohorts of six patients at 80 mg and 160 mg to assess safety, tolerability, and early signals of activity, including reduction in alcohol consumption and craving. Part C will run concurrently in healthy participants as a double-blind, placebo-controlled segment testing 160 mg daily for five consecutive days to further characterize safety and tolerability.

The multicenter study is designed to assess safety, tolerability, pharmacokinetics, and preliminary efficacy on drinking patterns and alcohol craving, and is being conducted at Johns Hopkins University, Yale School of Medicine, Tel Aviv Sourasky Medical Center, and Hadassah Medical Center. The company said it expects to provide further updates as enrollment progresses.