Clearmind Medicine (NASDAQ:CMND) has announced that it has received Institutional Review Board (IRB) approval from one of its U.S. clinical sites for part A of its Phase I/IIa clinical trial of CMND-100 for the treatment of patients suffering from alcohol use disorder (AUD).
The multinational, multi-center trial will assess the safety, tolerability, and pharmacokinetics of Clearmind’s 5-methoxy-2-aminoindane (MEAI)—based CMND-100 treatment for AUD. In addition to Johns Hopkins University in Maryland, the trial will also take place at Yale School of Medicine in Connecticut, and at IMCA Center in Ramat Gan, Israel. FDA approval for its IND application to conduct the trial in the U.S. has already been granted, and Clearmind has received approval from the Israeli Ministry of Health. Additionally, IMCA’s IRB approval has been secured.
In a statement, Dr. Adi Zuloff-Shani, CEO of Clearmind, said, “IRB approval marks another key milestone towards the launch of our Phase I/IIa clinical trial for alcohol use disorder. Together with the IMCA approval, this becomes our second approved site, bringing us closer to offering hope to those suffering from the devastating effects of alcohol addiction. Alcohol abuse is a major global health issue and one of the leading preventable causes of death, particularly in the U.S., where AUD is the most common substance use disorder among people aged 12 and older.”
