Clearmind Medicine Gets IRB Approval for FDA First-In-Human Trial of CMND-100 at Second Site

Clearmind Medicine Inc., a Vancouver-based clinical-stage biotechnology firm listed on Nasdaq and the Frankfurt Stock Exchange, has announced a significant advancement in its efforts to address alcohol use disorder (AUD). The company has secured Institutional Review Board (IRB) approval from one of its clinical sites in the United States for the initial phase of its Phase I/IIa clinical trial targeting AUD. Clearmind Medicine, known for its focus on developing psychedelic-derived therapeutics, is conducting this trial to evaluate its proprietary treatment, CMND-100, which is based on the compound MEAI (5-methoxy-2-aminoindane).

The trial, which spans multiple countries and centers, aims to investigate the safety, tolerability, and pharmacokinetics of CMND-100. The research will be conducted at prestigious institutions including Johns Hopkins University in Maryland, Yale School of Medicine in Connecticut, and the IMCA Center in Ramat Gan, Israel. The company has also received FDA approval for its Investigational New Drug (IND) application in the United States, as well as approval from the Israeli Ministry of Health. Additionally, the IMCA Center's IRB has granted its approval for the trial.

Dr. Adi Zuloff-Shani, the CEO of Clearmind Medicine, expressed that the IRB approval is a crucial step towards initiating their clinical trial for AUD. Highlighting the significance of this milestone, Dr. Zuloff-Shani noted that the approval from both the IMCA Center and the U.S. clinical site brings the company closer to providing a potential new treatment option for individuals struggling with alcohol addiction. AUD remains a significant global health challenge and is a leading preventable cause of death, especially in the United States, where it is the most prevalent substance use disorder among individuals aged 12 and older.

The primary goal of the trial, which is officially 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 identify a tolerable dose and to assess the safety, pharmacokinetics, and pharmacodynamics of CMND-100. This study represents an essential step in the development and potential commercialization of Clearmind's innovative therapeutic approach to AUD.

Clearmind Medicine Inc. is dedicated to addressing widespread and underserved health conditions through the discovery and development of novel psychedelic-derived therapeutics. The company's research efforts are primarily focused on creating and commercializing compounds derived from psychedelics, with the objective of offering these as regulated medicines, foods, or supplements. Clearmind's intellectual property portfolio includes nineteen patent families with a total of twenty-nine granted patents. The company remains proactive in seeking additional patents and acquiring new intellectual property to expand its portfolio.

Clearmind Medicine's shares are publicly traded on Nasdaq under the symbol "CMND" and on the Frankfurt Stock Exchange under the symbol "CWY0." The company continues to advance its research and development efforts, aiming to provide innovative solutions for significant health issues such as alcohol use disorder.