Clearmind Medicine receives approval to continue phase I trial

Clearmind Medicine Inc. (NASDAQ: CMND) announced that its independent Data and Safety Monitoring Board unanimously recommended continuation of the company's Phase I/IIa clinical trial for CMND-100 following an interim safety review.

The trial evaluates CMND-100, described as a non-hallucinogenic neuroplastogen, for treating alcohol use disorder. The Vancouver-based clinical-stage biotech company said the DSMB reviewed unblinded safety data from the initial dosing cohort of the multinational, multi-center study.

According to the company, the review found no serious adverse events, general good tolerability across participants, and high adherence to the dosing regimen and study protocol. The DSMB comprises independent experts including specialists in psychiatry, a biostatistician and a neuropsychopharmacologist.

"This DSMB recommendation is a pivotal milestone for Clearmind and reinforces our confidence in CMND-100's safety and therapeutic potential," said Dr. Adi Zuloff-Shani, CEO of Clearmind Medicine.

The FDA-approved trial assesses safety, tolerability, pharmacokinetic profile, and preliminary efficacy of CMND-100 in reducing alcohol cravings and consumption among individuals with moderate to severe alcohol use disorder.

Clearmind established the DSMB in 2023 to oversee the first-in-human aspects of the trial. The company's intellectual portfolio includes 19 patent families with 31 granted patents.

Clearmind shares trade on Nasdaq under the symbol CMND and on the Frankfurt Stock Exchange as CWY0.

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