Clearmind Medicine Inc, a clinical-stage biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, announced that it has received Institutional Review Board (IRB) approval from Tel Aviv Sourasky Medical Center (TASMC) in Tel Aviv, Israel, for its ongoing phase 1/2a clinical trial evaluating CMND-100, a proprietary MEAI-based oral drug candidate, for the treatment of alcohol use disorder (AUD). This approval will enable patient enrollment at TASMC, a leading clinical site in Israel, prior to commencing this first-in-human trial at the site.
The trial includes other first-in-class institutions, such as Yale School of Medicine’s Department of Psychiatry, Johns Hopkins University School of Medicine and Hadassah-University Medical Center in Jerusalem, Israel. The study at TASMC will be led by Dr. David Zeltser, director of the Emergency medicine department and deputy director R&D and innovation.
Clearmind recently announced the dosing of the first participant in the trial, marking a historic step toward developing a novel therapy for the millions affected by alcohol use disorder worldwide.
IRB approval from TASMC follows Clearmind’s prior regulatory milestones, including US Food and Drug Administration (FDA) clearance of its Investigational New Drug application and IRB approvals from other clinical sites.
“We are pleased to receive IRB approval from Tel Aviv Sourasky Medical Center, a renowned institution, for our phase 1/2a clinical trial,” said Dr. Adi Zuloff-Shani, CEO of Clearmind Medicine. “This milestone brings us closer to potentially offering a transformative treatment for individuals struggling with AUD, a condition that devastates millions of lives. With TASMC’s participation, alongside leading centers like Yale and Johns Hopkins, we believe that we are well-positioned to advance our mission of developing safe, effective, and innovative psychedelic-derived therapies.”
Clearmind’s clinical trial is a critical step in addressing the global burden of AUD, which accounts for 4.7% of all deaths worldwide, according to the World Health Organization. The company anticipates further progress in patient enrollment and data collection across its clinical sites, with the goal of delivering a breakthrough solution for those affected by AUD and their families. The phase 1/2a clinical trial, a multinational, multi-center study, is designed to assess the safety, tolerability, and pharmacokinetic profile of CMND-100, while also evaluating its preliminary efficacy in reducing alcohol cravings and consumption in patients with AUD. |