On November 24, Clearmind Medicine Inc. reported that its independent Data and Safety Monitoring Board (DSMB) completed a scheduled interim review of the company’s FDA‑approved Phase I/IIa trial for CMND‑100 and unanimously recommended that the study continue. The DSMB, composed of experts in psychiatry, biostatistics and neuropsychopharmacology, evaluated unblinded safety data from the first dosing cohort and found a favorable safety profile, with no serious adverse events and tolerability rates that met the study’s predefined criteria.
The recommendation allows Clearmind to accelerate enrollment across its multi‑center network, which includes sites at Johns Hopkins University, Yale School of Medicine and several Israeli centers such as Hadassah Medical Center and Tel Aviv Sourasky Medical Center. The DSMB was established in 2023 to oversee the first‑in‑human aspects of the trial, and its endorsement confirms that the early‑phase study is proceeding without safety concerns.
Dr. Adi Zuloff‑Shani, CEO of Clearmind, said the DSMB’s decision “is a pivotal milestone for Clearmind and reinforces our confidence in CMND‑100’s safety and therapeutic potential.” He added that the positive interim data, combined with the DSMB’s endorsement, positions the company to accelerate enrollment and advance the treatment toward addressing the unmet needs in alcohol use disorder.
The milestone underscores Clearmind’s progress in its clinical development pipeline and signals that CMND‑100, a non‑hallucinogenic neuroplastogen based on MEAI, is on track to generate the preliminary efficacy data needed to support future regulatory submissions. The company’s focus on a novel, non‑psychedelic approach to AUD could differentiate it in a crowded therapeutic landscape and potentially open a new market segment for neuroplasticity‑based treatments.
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