Clearmind Medicine Moves to Fourth Cohort After Positive Safety Review of CMND-100 AUD Trial

Clearmind Medicine Inc., a clinical-stage biotechnology company developing non-hallucinogenic, second-generation neuroplastogen-based treatments for major under-treated health conditions, announced that its independent Data and Safety Monitoring Board (DSMB) has completed its latest review of the ongoing Phase I/IIa clinical trial evaluating CMND-100 for Alcohol Use Disorder (AUD). The DSMB has issued a positive recommendation, allowing the study to continue without any changes.

This recommendation follows the successful completion of the trial’s third cohort. The top-line safety findings reviewed by the DSMB showed that CMND-100 was well tolerated by patients, and no serious adverse events were reported. These results are in line with the favorable safety and tolerability outcomes observed in earlier cohorts of the study, reinforcing confidence in the continued clinical development of the drug candidate.

Following the DSMB’s approval, the company will now move forward to the fourth cohort of the trial. In this next stage, the tested dose of CMND-100 will be increased to 160 mg. This progression is an important step in assessing the drug’s safety across a broader dose range.

The Phase I/IIa clinical trial is an FDA-approved, multinational, multicenter study designed to evaluate several key aspects of CMND-100, including its safety, tolerability, pharmacokinetics, and early signs of clinical effectiveness. The drug candidate is an oral, non-hallucinogenic MEAI-based therapy being developed for individuals diagnosed with moderate to severe AUD. The study aims to better understand how the compound behaves in the body and whether it shows potential as a new treatment option for this widespread and challenging condition.

By advancing into the fourth cohort, Clearmind Medicine Inc. continues to make steady progress in the development of CMND-100 and remains focused on addressing the significant unmet needs associated with Alcohol Use Disorder.