Clearmind Medicine Inc. announced that it has received approval from the Israeli Ministry of Health to commence its phase I/IIa clinical trial for alcohol use disorder (AUD) patients using the company's proprietary MEAI-based (5-methoxy-2-aminoindane) CMND-100 oral capsule. The approval, previously announced on February 23, 2024, allows Clearmind to start its pioneering clinical trial. The clinical trial is a multinational, multi-center, single and multiple dose tolerability, safety and pharmacokinetic study of CMND-100 in healthy volunteers and AUD subjects.
The Israeli study will be led by Prof. Mark Weiser, M.D., head of the Psychiatric Division at the Sheba Medical Center in the Tel Aviv suburb of Ramat Gan. The company intends to have two additional sites in the United States for the phase I/IIa clinical trial, at the Yale School of Medicine?s Department of Psychiatry and the Johns Hopkins University School of Medicine. The primary endpoint of the clinical trial is to find the tolerable dose and characterize the safety and pharmacokinetics/pharmacodynamics of single and repeated doses of CMND-100 in healthy subjects and those with AUD.
The secondary endpoint is to evaluate the preliminary efficacy of CMND-100 in reduction of drinking patterns and cravings in individuals with moderate-to-severe AUD. Oral capsules will be administered and subjects treated by these oral capsules will report their drinking patterns and cravings for alcohol during the clinical trial. The active ingredient in CMND-100 is MEAI, an innovative, psychoactive and non-hallucinogenic molecule that has been reported to reduce the desire to consume alcoholic beverages, while exerting a slight euphoric alcohol-like experience.
MEAI was found to interact with the serotonergic receptors 5-HT1a and 5-HT2a. The serotonergic system is considered to play a key role in the regulation of alcohol intake, reward, preference, and dependence. MEAI was also found to interact with the alpha-2-adrenergic receptors a2A, a2B and a2C, as well as the plasma membrane monoamine transporters for dopamine (DAT), norepinephrine (NET) and serotonin (SERT).
These receptors and transporters are believed to participate in mediating alcohol drinking behavior and could constitute important molecular targets for interventions that target drugs subject to abuse, such as alcohol.
