Clearmind Medicine Begins Enrollment For Third Cohort In FDA-Approved Phase I/IIa Trial Of Non-Hallucinogenic AUD Treatment CMND-100

Clearmind Medicine Inc., a clinical-stage biotechnology company focused on developing non-hallucinogenic, second-generation therapeutics for major under-treated health challenges, has announced that it is now enrolling participants for the third cohort of its ongoing FDA-approved Phase I/IIa clinical trial. The study is evaluating CMND-100, an oral drug candidate based on MEAI, designed to treat Alcohol Use Disorder (AUD) without producing hallucinogenic effects.

The decision to move ahead with the next stage of the trial comes shortly after the company reported positive topline results from the second cohort. These results showed that CMND-100 continued to demonstrate safety and tolerability, reinforcing the encouraging findings from earlier participants. After reviewing all available data, the independent Data and Safety Monitoring Board (DSMB) granted unanimous approval to proceed, confirming that the trial could safely advance to the next group of participants.

This Phase I/IIa trial is structured as a multinational, multicenter study aimed at assessing several key factors: safety, tolerability, pharmacokinetics, and early indications of how effective CMND-100 may be for individuals with moderate to severe AUD. The third cohort is now being recruited at several leading research sites, including Yale University, Johns Hopkins University, and Tel Aviv Sourasky Medical Center. These institutions are recognized for their expertise in addiction research, which adds further momentum and credibility to the development of CMND-100 as a potential new treatment option.

Dr. Adi Zuloff-Shani, Chief Executive Officer of Clearmind Medicine, expressed optimism about the continued progress of the study. She noted that the positive data from both the first and second cohorts support the belief that CMND-100 could offer a safe and well-tolerated alternative for people struggling with alcohol use disorder. She also emphasized an important advantage of the treatment: it does not require additional psychotherapy, allowing it to remain accessible, discreet, and convenient for patients.

Dr. Zuloff-Shani added that the company remains committed to moving the trial forward and working toward innovative, safe, and affordable therapeutic options for individuals in need. The ongoing enrollment marks another important step in the development of CMND-100 and its potential role in addressing one of the most persistent and widespread health issues worldwide.