Clearmind Medicine Inc (NASDAQ:CMND) saw its stock slide 6.6% on Monday following the release of supplementary safety data from the second cohort of its ongoing Phase I/IIa clinical trial testing CMND-100 for Alcohol Use Disorder (AUD).
The company disclosed that safety information collected from six additional participants in cohort two showed no serious adverse events and demonstrated good overall tolerability. Clearmind said these observations are consistent with the safety profile reported for the first cohort.
CMND-100 is being evaluated as a non-hallucinogenic, MEAI-based oral therapy. The multicenter study is being conducted at several sites, including Johns Hopkins University, Tel Aviv Sourasky Medical Center, and Hadassah Medical Center.
While the company described the update as "positive" and "encouraging," the market response was negative, with investors evidently weighing the announcement as a reinforcement of previously disclosed safety findings rather than new evidence of clinical efficacy.
"These additional topline safety results from the second cohort further validate and reinforce the positive profile we observed in the first cohort," said Dr. Adi Zuloff-Shani, Chief Executive Officer of Clearmind Medicine, in the company announcement.
Trial scope and oversight
The ongoing multinational Phase I/IIa trial is structured to assess safety, tolerability, pharmacokinetics, and preliminary efficacy of CMND-100 in individuals with moderate to severe AUD. Clearmind noted that the Data and Safety Monitoring Board reviewed the first cohort data and unanimously approved progression to the second cohort.
Clearmind is positioning CMND-100 as a potential treatment option that is non-hallucinogenic and would not require adjunct psychotherapy, presenting it as a distinct approach within the AUD treatment landscape.
The recent update focused on safety outcomes from a limited group of patients in the second cohort. The company characterized the results as supportive of the profile observed in cohort one but did not present new efficacy data in this release. Market participants responded by selling shares despite the favorable safety signals.
As the trial continues to evaluate multiple endpoints across participating sites, additional data releases will be necessary to address efficacy questions and broader clinical implications.