Clearmind reports clean CMND-100 safety data across dose escalation

Clearmind Medicine has reported positive safety results from Part A of its FDA-regulated Phase I/II clinical trial evaluating CMND-100, its proprietary oral candidate for Alcohol Use Disorder, saying the study met its primary endpoint of safety and tolerability across the full dose-escalation sequence.

All 24 healthy volunteers enrolled across four cohorts completed treatment per-protocol. Doses tested ranged from approximately 20 mg to 160 mg in a sequential single-ascending-dose design, with six participants per cohort. The company said no serious adverse events were observed at any dose level, including the highest, and that the tolerability profile was consistent throughout.

Trial design and differentiation

CMND-100 is an oral formulation of MEAI (5-methoxy-2-aminoindane), which Clearmind classifies as a non-hallucinogenic neuroplastogen-derived compound. The distinction matters clinically and commercially: classical psychedelic-assisted therapies, such as those involving psilocybin or MDMA, typically require extended monitored sessions and trained facilitator support, creating logistical and regulatory complexity that has slowed their path to broad adoption. Clearmind is positioning CMND-100 as a candidate that could support more scalable treatment models without intensive supervision.

The multicenter trial is being conducted at Yale School of Medicine, Johns Hopkins University School of Medicine, Tel Aviv Sourasky Medical Center, and Hadassah Medical Center. Clearmind said it is completing its analysis of the full Part A dataset and, assuming findings remain favourable, intends to advance to cohorts enrolling AUD patients.

Adi Zuloff-Shani, chief executive of Clearmind, said the data "reinforce our confidence as we advance CMND-100 and evaluate the next stages of development for patients with Alcohol Use Disorder."

Market and competitive context

Alcohol Use Disorder affects an estimated 400 million people worldwide and remains heavily underserved by existing pharmacotherapy. Approved options including naltrexone, acamprosate, and disulfiram carry modest efficacy and tolerability limitations that constrain uptake, leaving significant unmet need. That gap has drawn a range of approaches into development, from GLP-1 receptor agonists being investigated off-label through to several psychedelic-adjacent programmes.

The non-hallucinogenic neuroplastogen niche is relatively early stage, with a small number of academic groups and clinical-stage companies exploring compounds that aim to capture the neuroplasticity-promoting properties of psychedelics without the perceptual effects that complicate clinical delivery and scheduling.