Clearmind Medicine Inc. (NASDAQ: CMND) announced on 21 October 2025 that it has enrolled the final patient in the first cohort of its FDA‑approved Phase I/IIa clinical trial evaluating CMND‑100, the company’s proprietary MEAI‑based oral candidate for Alcohol Use Disorder (AUD). The milestone completes the initial enrollment phase of the multinational, multi‑site study, which is now fully staffed at Johns Hopkins University School of Medicine and Yale School of Medicine’s Department of Psychiatry.
Six patients have been successfully enrolled to date—two at Johns Hopkins and four at Yale—meeting the cohort size target set by the trial protocol. The study is designed as a single‑ and multiple‑dose investigation to assess safety, tolerability, pharmacokinetics, and preliminary efficacy signals such as reductions in alcohol cravings and consumption among both non‑treatment‑seeking heavy binge drinkers and treatment‑seeking individuals diagnosed with AUD per DSM‑5 criteria.
CEO Dr. Adi Zuloff‑Shani said the completion of cohort enrollment “represents a key inflection point in our CMND‑100 program” and highlighted the efficient timeline achieved. He noted that the momentum from Yale and Johns Hopkins site activations underscores growing interest in MEAI‑based therapeutics and reaffirms Clearmind’s commitment to delivering safe, effective solutions for the underserved AUD community.
The company plans to share topline data from the first cohort in the coming weeks, with the next phase of the trial expected to begin once the additional Israeli sites are activated. Successful early enrollment positions Clearmind to maintain, or even accelerate, its projected enrollment pace and brings the company closer to generating the clinical evidence needed for regulatory approval and eventual commercialization.
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