Clearmind’s DSMB Approves Continued Phase I/IIa Trial with 80 mg Third Cohort
Clearmind Medicine’s independent DSMB unanimously recommended continuation of its FDA-approved Phase I/IIa trial of CMND-100 for Alcohol Use Disorder after the second cohort, which received double the initial dose, showed favorable safety without serious adverse events. The third cohort will escalate to 80 mg per administration.
1. DSMB Recommendation
Clearmind Medicine’s independent Data and Safety Monitoring Board completed the second scheduled interim review of the FDA-approved Phase I/IIa trial of CMND-100 in Alcohol Use Disorder and recommended that the study continue.
2. Second Cohort Safety Data
In the second cohort, participants received twice the dose administered in the first cohort and experienced no drug-related serious adverse events or suicidality-related safety signals, demonstrating a favorable tolerability profile consistent with initial findings.
3. Third Cohort Advancement
The DSMB’s unanimous approval enables rapid progression to the third cohort, which will administer 80 mg per dose, double the second cohort’s dose, to further evaluate safety and support ongoing trial milestones.