Clearmind Medicine (CMND) announced that its independent Data and Safety Monitoring Board has completed a scheduled interim review of the Company’s ongoing FDA-approved Phase I/IIa clinical trial for CMND-100, a proprietary, non-hallucinogenic neuroplastogen, in the treatment of Alcohol Use Disorder. Based on the encouraging top-line data from the first cohort, which demonstrated a favorable safety profile, the DSMB unanimously recommended that the clinical trial continue. The multinational, multi-center trial is evaluating the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of CMND-100 in reducing alcohol cravings and consumption among individuals with moderate to severe AUD. The DSMB, comprised of independent experts including specialists in psychiatry, a biostatistician and a neuropsychopharmacologist conducted a thorough review of unblinded safety data from the initial dosing cohort. Key findings included: No serious adverse events reported. General good tolerability across all participants. Strong treatment observance, with high adherence to the dosing regimen and study protocol.
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