The independent Data and Safety Monitoring Board on Thursday unanimously approved Clearmind Medicine Inc. (NASDAQ:CMND) to advance its ongoing FDA-regulated Phase 1/2 clinical trial.

The study evaluates CMND-100, a clinical candidate aimed at treating Alcohol Use Disorder (AUD), in Parts B and C of the trial.

The progression follows the successful conclusion of Part A. In that initial phase, CMND-100 achieved its primary safety endpoint, displaying a positive safety and tolerability profile across all planned dose levels in healthy individuals.

After a thorough review of the safety dataset, the board recommended moving forward with the previously approved study protocol.

Transitioning To Patient Testing

Part B serves as a critical clinical milestone for the biotech company, which focuses on non-hallucinogenic therapeutics for under-treated health issues like addiction and weight loss.

For the first time, CMND-100 will be tested on patients actively suffering from moderate to severe AUD.

Researchers will sequentially enroll two groups of six patients to receive 80 mg and 160 mg doses. This phase will evaluate safety, tolerability, and early clinical activity, notably the drug’s potential to decrease alcohol consumption and suppress cravings.

Simultaneously, Part C will involve healthy volunteers receiving a fixed daily dose of 160 mg over five consecutive days. This double-blind, placebo-controlled section is intended to define the drug’s safety profile further.

Scalable, Non-Hallucinogenic Approach

CMND-100 is a proprietary oral formulation of MEAI (5-methoxy-2-aminoindane).

As a neuroplastogen-derived candidate, it promotes adaptive neuroplasticity without triggering the perceptual effects seen in classical psychedelics.

This supports a scalable treatment model that successfully avoids the need for prolonged monitored sessions or intensive clinical supervision.

CMND Price Action: Clearmind Medicine shares were up 9.09% at $1.80 at the time of publication on Thursday. The stock is trading near its 52-week low of $1.43, according to Benzinga Pro data.

Image via Nicole Hester via Imagn Images