Clearmind Medicine Inc. (Nasdaq: CMND) has achieved a significant milestone with Institutional Review Board (IRB) approval for its Phase I/IIa clinical trial of CMND-100, a novel therapeutic targeting alcohol use disorder (AUD). The trial, set to commence at Yale School of Medicine's Department of Psychiatry, will evaluate the safety, tolerability, and efficacy of CMND-100 in reducing alcohol cravings and consumption among individuals with moderate to severe AUD.
Addressing a Critical Unmet Need
Alcohol use disorder represents a substantial global health challenge. According to the World Health Organization, alcohol consumption is responsible for 2.6 million deaths annually worldwide, accounting for 4.7% of all global deaths. In the United States, excessive alcohol use is a leading preventable cause of death and imposes a significant economic burden, with billions spent on healthcare costs.
Current treatment options for AUD are often limited by high costs, low efficacy (less than 30%), and poor patient compliance due to side effects. Clearmind Medicine aims to address this critical gap by developing CMND-100, a psychedelic-derived therapeutic with the potential to offer a more effective and accessible solution for treating AUD.
Trial Design and Objectives
The Phase I/IIa clinical trial will be led by Dr. Anahita Bassir Nia, an expert in psychiatry and addiction medicine at Yale School of Medicine. The study is designed to gather critical data supporting the advancement of CMND-100 through the clinical pipeline. The primary objective is to assess CMND-100's ability to reduce alcohol cravings and consumption among individuals with moderate to severe AUD.
"Receiving the IRB approval from Yale University takes us one step closer to commencing our innovation clinical trial with our proprietary CMND-100 for treating AUD patients," said Dr. Adi Zuloff-Shani, CEO of Clearmind Medicine. "We believe we have a unique opportunity to address this critical gap and provide an effective solution for treating this widespread condition."
Clearmind Medicine's Pipeline and Intellectual Property
Clearmind Medicine 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. The company's intellectual portfolio currently consists of nineteen patent families including 29 granted patents. Clearmind 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.
