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 the enrollment of the last patient for the first cohort of its Phase IIIa clinical trial evaluating CMND-100, the Company's proprietary MEAI-based oral drug candidate for the treatment of Alcohol Use Disorder (AUD).
To date, six patients have been successfully enrolled into the trial, Of these, two patients were enrolled at Johns Hopkins University School of Medicine and four at Yale School of Medicine's Department of Psychiatry.
The multinational, multicenter Phase I/IIa trial is designed as a single- and multiple-dose study to assess the safety, tolerability, and pharmacokinetic profile of CMND-100. It will also explore preliminary efficacy signals, such as reductions in alcohol cravings and consumption, among participants who are either non-treatment-seeking individuals reporting heavy binge drinking or treatment-seeking individuals diagnosed with AUD per DSM-5 criteria. All participants must express a desire to reduce or stop drinking. Following FDA Investigational New Drug (IND) approval, the trial represents a critical step in advancing CMND-100 as a potential innovative therapy for the hundreds of millions worldwide affected by AUD, a condition where current treatments often fall short.
"With the enrollment of the last patient in our first cohort, we are thrilled to reach this key inflection point in our CMND-100 trial, within an excellent timeline" said Dr. Adi Zuloff-Shani, Chief Executive Officer of Clearmind Medicine. "Building on the momentum from our first cohort enrollment and site activations at world-class institutions like Yale and Johns Hopkins, this progress underscores the growing interest in MEAI-based therapeutics and our commitment to delivering safe, effective solutions for the underserved AUD community. We look forward to sharing topline data from the first cohort as we continue to accelerate this groundbreaking program. Enrollment was completed within excellent and efficient timelines, and we hope that with the activation of the two additional sites based in Israel to the trial, we will be able to maintain, and perhaps even improve, this excellent pace of enrollment."
The trial is registered on ClinicalTrials.gov (NCT05913752). For more information, visit Clearmind Medicine's website.
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 31 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."