Vancouver, Canada, Oct. 10, 2024 (GLOBE NEWSWIRE) — Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the “Company”), a clinical-stage biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, today announced it has received Institutional Review Board (IRB) approval from one of its clinical sites in the U.S. for part A of its Phase I/IIa clinical trial in the United States for treating patients suffering from alcohol use disorder (AUD).
The multinational, multi-center trial will assess the safety, tolerability, and pharmacokinetics of Clearmind’s innovative MEAI-based (5-methoxy-2-aminoindane) treatment, CMND-100. In addition to Johns Hopkins University, Maryland, USA, the trial will also take place at Yale School of Medicine, Connecticut, USA and IMCA Center in Ramat Gan, Israel. The Company has already secured FDA approval for its Investigational New Drug (IND) application to conduct the trial in the U.S., as well as approval from the Israeli Ministry of Health. IMCA’s IRB approval has also been granted.
Dr. Adi Zuloff-Shani, CEO of Clearmind Medicine, commented: “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 older1.”
The primary endpoint of the trial, titled A Phase I/II Single and Multiple Dose Tolerability, Safety and Pharmacokinetic Study of CMND-100 in Healthy Volunteers and Subjects with Alcohol Use Disorder (AUD), is to determine the tolerable dose and evaluate the safety, pharmacokinetics, and pharmacodynamics of CMND-100. More information is available at clinicaltrials.gov.
About Clearmind Medicine Inc.
Clearmind is a clinical-stage psychedelic pharmaceutical biotech company focused on the discovery and development of novel psychedelic-derived therapeutics to solve widespread and underserved health problems, including alcohol use disorder. Its primary objective is to research and develop psychedelic-based compounds and attempt to commercialize them as regulated medicines, foods or supplements.
The Company’s intellectual portfolio currently consists of nineteen patent families including 29 granted patents. The Company intends to seek additional patents for its compounds whenever warranted and will remain opportunistic regarding the acquisition of additional intellectual property to build its portfolio.
Shares of Clearmind are listed for trading on Nasdaq under the symbol “CMND” and the Frankfurt Stock Exchange under the symbol “CWY0.”