Clearmind Medicine Inc. Reports DSMB Clears Its Phase I/IIa CMND-100 Trial To Continue After Positive Second Interim Safety Review

Clearmind Medicine Inc., a clinical-stage biotechnology company developing second-generation neuroplastogen-based therapeutics for difficult and under-treated health conditions, announced that its independent Data and Safety Monitoring Board has completed the second planned interim review of the company’s FDA-approved Phase I/IIa clinical trial for CMND-100. CMND-100 is Clearmind’s proprietary, non-hallucinogenic neuroplastogen being developed for the treatment of Alcohol Use Disorder (AUD). 

Following its review, the Data and Safety Monitoring Board recommended that the study continue, noting favorable safety findings from the latest treatment group. The new safety results come after another six participants in the second cohort completed treatment. These findings add to the positive safety and tolerability signals previously shared in January 2026 and provide further support for CMND-100’s emerging safety profile, which was first observed in the initial cohort.

In the second cohort, participants received double the dose administered in the first cohort. Despite the increased dosing, no serious adverse events were reported, and overall tolerability remained strong. These results mirror the encouraging outcomes seen earlier and contributed to the DSMB’s unanimous approval to move forward with the third cohort. The next cohort will involve an 80 mg dose per administration, which is twice the amount used in the second cohort.

The ongoing Phase I/IIa trial is a multinational, multicenter study designed to assess the safety, tolerability, pharmacokinetics, and early signs of efficacy of CMND-100 in people with moderate to severe AUD. The second cohort was conducted at several leading clinical research sites, including Johns Hopkins University, Tel Aviv Sourasky Medical Center, and Hadassah Medical Center. Completion of treatment at all study locations shortly after DSMB clearance demonstrates continued confidence in the safety of CMND-100 as Clearmind advances its development as a potential new therapeutic option for individuals living with AUD.