Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY) has chosen Yale School of Medicine as its first U.S. site for the company’s Phase I/IIa clinical trial of its proprietary MEAI-based CMND-100 compound for the treatment of alcohol use disorder.
In the clinical trial, Clearmind said that oral capsules would be administered once daily for 10 consecutive days. The patients will then report their drinking patterns and craving for alcohol (and cigarettes) during the clinical trial period.
The primary endpoint of the trial is to find the tolerable dose and characterize the safety and pharmacokinetics/pharmacodynamics (PK/PD) of single and repeated doses of CMND-100 in healthy subjects and in those with AUD.
The secondary end-point is to evaluate the efficacy of CMND-100 in the reduction of drinking patterns and cravings in individuals with moderate-to-severe AUD.
The active ingredient in CMND-100 is MEAI (5-methoxy-2-aminoindane), a novel psychoactive molecule and a psychoactive compound of the aminoindane class.
Clearmind said it would be led by Anahita Bassir Nia, a specialist in substance abuse, including alcohol abuse. She joined the Yale School of Medicine in 2018 as an assistant professor of psychiatry after completing her psychiatry residency at Mount Sinai Beth Israel and her addiction psychiatry fellowship at Mount Sinai West’s Icahn School of Medicine in New York.
“We see this collaboration with a global pioneer in psychedelics research, as further validation of our innovative drug candidate for potential treatment for alcohol use disorder,” said Clearmind’s CEO Dr. Adi Zuloff-Shani.
Clearmind recently announced it had been granted approval by the Ethics Committee (equivalent of an institutional review board) of Israel’s IMCA center for the Phase I/IIa clinical trial of CMND-100. The CM-CMND-001 clinical trial is a multinational, multicenter, Phase I/II single- and multiple-dose tolerability, safety, and pharmacokinetic study in healthy volunteers and AUD subjects.
“We believe that CMND-100 has the potential to be a game-changer in treating addictions and mental health concerns, as successfully demonstrated in previous pre-clinical studies,” added Zuloff-Shani. “With an extensive IP portfolio and an award-winning advisory board of renowned psychiatrists and researchers from around the world, we’re confident in our unique treatment model.
“CMND-100 is expected to provide immediate therapeutic benefit, as a self-administered and non-addictive prescription pill that is not dependent on expensive therapies.”