Clearmind Reports Positive Phase I/II Safety Results For CMND-100 Alcohol Use Disorder Drug, Clears First Clinical Milestone

Clearmind Medicine Inc., a clinical-stage biotechnology company developing non-hallucinogenic neuroplastogen-based therapies for Alcohol Use Disorder (AUD), addictions, and weight management, has announced positive safety results from Part A of its ongoing FDA-regulated Phase I/II clinical trial evaluating its lead oral drug candidate, CMND-100, for the treatment of Alcohol Use Disorder.

The study successfully achieved its primary objective of assessing the safety and tolerability of CMND-100. All 24 healthy volunteers enrolled in the trial completed treatment as planned across four ascending-dose cohorts. No serious adverse events were reported during the study, and the drug demonstrated a consistent safety and tolerability profile across all dose levels, including the highest dose tested. These results provide further support for the continued clinical development of CMND-100.

Part A of the trial evaluated single ascending oral doses of approximately 20 mg, 40 mg, 80 mg, and 160 mg, with six participants in each dose group. Successfully completing all planned dose levels while maintaining a favorable safety profile represents an important milestone for the program. The findings also reduce early-stage development risks and strengthen confidence in CMND-100 as a potential treatment for Alcohol Use Disorder.

CMND-100 is based on Clearmind's proprietary MEAI technology and is designed to promote neuroplasticity without causing hallucinogenic effects. Unlike traditional psychedelic therapies, which often face practical and regulatory challenges due to their perceptual effects, CMND-100 aims to offer a more accessible treatment option while maintaining a strong safety profile.

Commenting on the results, Dr. Adi Zuloff-Shani, Chief Executive Officer of Clearmind Medicine, said the successful completion of the dose-escalation phase with consistently positive safety and tolerability results marks a significant milestone for the CMND-100 program. She added that the findings strengthen the company's confidence as it prepares to move the drug candidate into the next stages of clinical development for patients with Alcohol Use Disorder.

The multicenter Phase I/II trial is being conducted under FDA oversight at leading research institutions in the United States and Israel, including Yale School of Medicine, Johns Hopkins University School of Medicine, Tel Aviv Sourasky Medical Center, and Hadassah Medical Center. Clearmind is currently reviewing the complete Part A data and, if the findings continue to remain positive, plans to move forward with the next phase of the clinical program, which will include dosing patients with Alcohol Use Disorder.