Clearmind Medicine Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for its proprietary MEAI-based (5-methoxy-2-aminoindane) CMND-100 oral capsule, allowing the Company to proceed with a Phase I/IIa clinical trial in the United States for treating patients with alcohol use disorder (AUD). While the Phase I/IIa clinical trial was already approved in Israel, clearance from the FDA will allow the trial to be initiated in the US. The Phase I/IIa clinical trials is a multinational, multi-center, single and multiple dose, tolerability, safety and pharmacokinetic trial of CMND-100 in healthy volunteers and AUD subjects.

The Company has signed agreements to perform the Phase I/IIa clinical study in leading universities in the United States, Yale School of Medicine's and the Johns Hopkins University School of Medicine. The Israeli trial will be conducted at the IMCA in the Tel Aviv suburb of Ramat Gan. The primary endpoint of the Phase I/IIaclinical 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 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).