Clearmind Medicine Inc. announced that the last patient of the first cohort in its Phase I/IIa clinical trial evaluating CMND-100, the Company's proprietary MEAI-based oral drug candidate for the treatment of Alcohol Use Disorder (AUD), has received treatment under the Company's U.S. Food and Drug Administration (FDA)-approved-approved clinical protocol. To date, six patients have been successfully enrolled and treated in the trial, with two patients enrolled at John Hopkins University School of Medicine and four patients enrolled at Yale School of Medicine's Department of Psychiatry- two of the world's leading centers for neuropsychiatric and addiction research, highlighting the high scientific and clinical standards guiding the study In addition, two additional sites in Israel have been activated for the Phase I/IIa clinical study. The multinational, multicenter Phase I/IIa trial is designed as a single- and multiple-dose study to assess the safety, tolerability, and pharmacokinetic profile of CMND-100.
It will also explore preliminary efficacy signals, such as reductions in alcohol cravings and consumption, among participants who are either non-treatment-seeking individuals reporting heavy binge drinking or treatment-seeking individuals diagnosed with AUD per DSM-5 criteria. All participants must express a desire to reduce or stop drinking. Following FDA Investigational New Drug (IND) approval, the trial represents a critical step in advancing CMND-100 as a potential innovative therapy for the hundreds of millions worldwide affected by AUD, a condition where current treatments often fall short.
The need for more effective AUD treatments remains urgent. According to Data Bridge Market Research, the global alcohol-dependency treatment market was valued at approximately $13.2 billion in 2024 and is projected to reach about $20 billion by 2032, illustrating the substantial unmet need and commercial opportunity for new therapeutic approaches.
