Clearmind Medicine Inc. (NASDAQ:CMND) reported that its drug candidate CMND-100 successfully met the primary safety and tolerability endpoint in an FDA-approved Phase I/IIa clinical study targeting alcohol use disorder, sending the company’s shares up 40%.
The Vancouver-based biotech firm said data from the trial’s third cohort demonstrated a strong safety profile for CMND-100, including at higher dose levels. The treatment was well tolerated, with no serious adverse events observed in this cohort, according to the company.
CMND-100 is a proprietary, non-hallucinogenic oral therapy derived from MEAI. The ongoing Phase I/IIa study is a multinational, multicenter trial designed to assess the drug’s safety, tolerability, pharmacokinetics, and early-stage efficacy in patients with moderate to severe alcohol use disorder.
The trial uses a dose-escalation approach, with the third cohort receiving the highest dosage tested so far. Clearmind said achieving the primary endpoint supports further development of CMND-100 as a potential treatment for alcohol use disorder.
The company is focused on advancing what it describes as neuroplastogen-based therapies and holds an intellectual property portfolio that includes 19 patent families and 31 granted patents.