Clearmind Medicine Hits 20-Participant Milestone in 160 mg AUD Trial
Clearmind Medicine has dosed two additional patients in the 160 mg fourth cohort of its FDA-approved Phase I/IIa CMND-100 trial for moderate to severe Alcohol Use Disorder, bringing total participants to 20. The first three cohorts met primary safety endpoints with no serious adverse events reported.
1. Milestone Achievement
Clearmind Medicine has successfully dosed two patients in the 160 mg fourth cohort of its FDA-approved Phase I/IIa trial of CMND-100 for moderate to severe Alcohol Use Disorder, bringing the total treated to 20 participants and marking progression into higher dose levels following DSMB approval.
2. Safety and Tolerability Data
Results from the first three cohorts, encompassing 18 patients, demonstrated no serious adverse events and met the trial’s primary safety endpoint, reinforcing the compound’s favorable tolerability profile as dose escalation advances.
3. Trial Design and Next Steps
The multinational, multicenter study at Yale School of Medicine, Johns Hopkins University School of Medicine, Tel Aviv Sourasky Medical Center, and Hadassah Medical Center will proceed with further dose escalation to assess pharmacokinetics and preliminary efficacy in upcoming cohorts.