Clearmind Gets DSMB Go-Ahead, Moves to Cohort Four at 160mg Dose
An independent Data and Safety Monitoring Board has granted a positive recommendation for Clearmind Medicine’s FDA-approved Phase I/IIa trial of CMND-100 in alcohol use disorder following completion of the third cohort. The trial will advance to its fourth cohort with CMND-100 dose increased to 160mg after no serious adverse events.
1. DSMB Recommendation and Trial Continuation
Clearmind’s independent Data and Safety Monitoring Board completed its review of the third cohort and issued a positive recommendation, allowing the FDA-approved Phase I/IIa trial of CMND-100 to proceed to the next stage.
2. Safety Data from Third Cohort
Top-line safety data from the third cohort showed that CMND-100 was well tolerated with no serious adverse events, reinforcing the favorable safety profile observed in earlier cohorts.
3. Fourth Cohort and Dose Escalation
The upcoming fourth cohort will investigate an increased oral dose of 160mg CMND-100 in patients with moderate to severe alcohol use disorder, aiming to evaluate tolerability and pharmacokinetics at this higher level.
4. Trial Design and Future Milestones
This multinational, multicenter study assesses safety, tolerability, pharmacokinetics and preliminary efficacy of the non-hallucinogenic MEAI-based CMND-100, with interim analyses scheduled after completion of later cohorts.