Clearmind Medicine Enrolls Last Patient for the First Cohort of its FDA-Approved Phase I/IIa Clinical Trial for Alcohol Use Disorder

Executive Summary

• Clearmind Medicine announced the enrollment of the last patient for the first cohort of its Phase I/IIa trial of CMND‑100, a MEAI‑based oral candidate for Alcohol Use Disorder (AUD).
• Six patients have now been enrolled across two U.S. sites (Johns Hopkins and Yale), with additional sites in Israel slated to open soon.
• The company will report topline data from this cohort once the study is completed, marking a key development milestone for the program.

Key Details

• Trial Design: Single‑ and multiple‑dose Phase I/IIa study evaluating safety, tolerability, pharmacokinetics, and preliminary efficacy (craving reduction & alcohol consumption).
• Enrollment Status: First cohort enrollment complete – 6 patients total (2 at Johns Hopkins University School of Medicine; 4 at Yale School of Medicine’s Department of Psychiatry).
• Target Population:
• Non‑treatment‑seeking heavy binge drinkers, and
• Treatment‑seeking individuals diagnosed with AUD per DSM‑5 who express a desire to reduce or stop drinking.
• Regulatory Context: Trial proceeds following FDA IND approval; registered on ClinicalTrials.gov (NCT05913752).
• Future Site Expansion: Two additional sites in Israel are being activated to sustain/enhance enrollment pace.
• Management Quote: CEO Dr. Adi Zuloff‑Shani highlighted the “key inflection point” and expressed confidence in delivering topline data soon.

Notable Quotes

“With the enrollment of the last patient in our first cohort, we are thrilled to reach this key inflection point in our CMND‑100 trial… We look forward to sharing topline data from the first cohort as we continue to accelerate this groundbreaking program.” – Dr. Adi Zuloff‑Shani, CEO

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Materiality Assessment: Material – Positive (completion of patient enrollment is a significant milestone for a clinical‑stage biotech and may influence investor perception and future valuation).