Clearmind Medicine Inc. (NASDAQ: CMND), has received Institutional Review Board (IRB) approval from Hadassah Medical Center in Jerusalem, Israel, allowing patient enrollment to begin for its ongoing Phase 1/2a clinical trial of CMND-100, an investigational oral therapy targeting Alcohol Use Disorder (AUD). This marks another regulatory milestone for the trial, which has already secured FDA Investigational New Drug (IND) clearance and IRB approvals from other leading research institutions.
The multi-center study includes collaborations with Yale School of Medicine’s Department of Psychiatry, Johns Hopkins University School of Medicine, and Tel Aviv Sourasky Medical Center. At Hadassah, the trial will be led by Prof. Joseph Caraco, Director of the Clinical Pharmacology Unit in the Department of Medicine.
CMND-100 is based on Clearmind’s proprietary MEAI compound and is being developed as a potential next-generation treatment for AUD. The trial aims to assess its safety, tolerability, and pharmacokinetics, while gathering preliminary data on its ability to reduce alcohol cravings and consumption. According to the World Health Organization, AUD contributes to 4.7% of deaths globally, highlighting the urgent need for innovative therapies.
“Receiving IRB approval from Hadassah, one of Israel’s leading medical institutions, strengthens our global clinical network and brings us closer to offering a transformative solution for AUD patients,” said Dr. Adi Zuloff-Shani, CEO of Clearmind Medicine. “Partnering with renowned centers like Yale and Johns Hopkins reflects the growing momentum behind our mission to advance psychedelic-based treatments for challenging mental health conditions.”
Clearmind expects to ramp up patient enrollment and data collection across all trial sites as it progresses toward developing a novel therapy for individuals and families affected by alcohol addiction.
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