Clearmind’s CMND-100 Hits Safety Endpoint in Phase I/IIa Alcohol Use Disorder Trial
CMND-100, Clearmind’s non-hallucinogenic MEAI-based oral drug, met the primary safety and tolerability endpoint in the third cohort of an FDA-approved Phase I/IIa trial for moderate to severe Alcohol Use Disorder, with no serious adverse events at the top tested dose. This result supports advancement into higher-dose cohorts.
1. Phase I/IIa Trial Design and Outcomes
The multinational, multicenter Phase I/IIa trial evaluated safety, tolerability, pharmacokinetics and preliminary efficacy of CMND-100 in patients with moderate to severe Alcohol Use Disorder. In the third cohort at the highest administered dose, CMND-100 met the primary safety and tolerability endpoint, with no serious adverse events and continued favorable tolerability matching earlier cohorts.
2. Drug Candidate Profile
CMND-100 is a proprietary, non-hallucinogenic MEAI-based oral therapeutic designed to induce neuroplasticity without psychedelic effects, specifically targeting alcohol use disorder. The candidate embodies a second-generation neuroplastogen approach aimed at addressing under-treated addiction conditions through regulated medicinal formulations.
3. Next Steps and Strategic Implications
Achieving the primary endpoint paves the way for higher-dose cohort enrollment and forthcoming efficacy-focused trials, potentially accelerating progression to Phase II studies. Positive safety data could boost investor confidence and leverage Clearmind’s 19 patent families as it advances toward commercial AUD treatment development.