Clearmind's CMND-100 Clears Phase I/IIa Safety Endpoint with No Serious Adverse Events
Clearmind's non-hallucinogenic oral candidate CMND-100 met the primary safety and tolerability endpoint in its FDA-approved Phase I/IIa alcohol use disorder trial, demonstrating no serious adverse events in the third dose-escalation cohort. These results support continued clinical development of CMND-100 as a potential novel treatment for moderate to severe AUD.
1. Trial Design and Objectives
The multinational, multicenter Phase I/IIa study is evaluating safety, tolerability, pharmacokinetics and preliminary efficacy of CMND-100 in patients with moderate to severe alcohol use disorder. The dose-escalation protocol comprises multiple cohorts, with the third cohort receiving the highest dose tested to date under FDA approval.
2. Third Cohort Safety Results
In the third cohort, CMND-100 exhibited a high safety profile at the increased dosage, with no serious adverse events reported and overall tolerability consistent with earlier cohorts. These top-line safety results confirm the primary endpoint and validate the non-hallucinogenic MEAI-based compound’s favorable risk profile.
3. Next Steps and Development
Meeting the primary safety and tolerability endpoint enables Clearmind to advance CMND-100 into later-stage studies or expanded Phase II trials. The company plans to leverage these findings to optimize dosing strategies and further explore efficacy endpoints in treating alcohol use disorder.