Clearmind receives IRB approval for alcohol disorder treatment trial

VANCOUVER - Clearmind Medicine Inc. (Nasdaq:CMND), a micro-cap biotech company with a market capitalization of $4.64 million, announced Thursday it has received Institutional Review Board approval from Tel Aviv Sourasky Medical Center for its ongoing Phase 1/2a clinical trial evaluating CMND-100 for Alcohol Use Disorder treatment. According to InvestingPro data, the company’s stock has declined about 40% over the past year.

The approval allows patient enrollment at the Israeli medical center, joining other participating institutions including Yale School of Medicine’s Department of Psychiatry, Johns Hopkins University School of Medicine, and Hadassah-University Medical Center in Jerusalem. While the company maintains a Fair financial health rating according to InvestingPro analysis, with a notably strong current ratio of 1.74, investors should note that the company is not yet profitable.

The multinational study will assess safety, tolerability, and pharmacokinetic profile of CMND-100, a proprietary MEAI-based oral drug candidate, while evaluating its preliminary efficacy in reducing alcohol cravings and consumption in AUD patients.

Dr. David Zeltser, Director of the Emergency Medicine Department and Deputy Director R&D and Innovation, will lead the study at Tel Aviv Sourasky Medical Center.

"This milestone brings us closer to potentially offering a transformative treatment for individuals struggling with AUD, a condition that devastates millions of lives," said Dr. Adi Zuloff-Shani, CEO of Clearmind Medicine, in the press release.

The company recently announced dosing of the first participant in the trial. This follows previous regulatory milestones including U.S. Food and Drug Administration clearance of its Investigational New Drug application.

According to the World Health Organization data cited in the company’s statement, Alcohol Use Disorder accounts for 4.7% of all deaths worldwide.

Clearmind Medicine is a clinical-stage psychedelic pharmaceutical biotech company focused on developing novel psychedelic-derived therapeutics. The company’s intellectual portfolio currently includes nineteen patent families with 31 granted patents. InvestingPro analysis reveals the company holds more cash than debt on its balance sheet, positioning it for continued research and development activities. Subscribers can access 5 additional ProTips and comprehensive financial metrics to better evaluate the company’s investment potential.

In other recent news, Clearmind Medicine Inc. has dosed the first participant in its Phase I/IIa clinical trial for CMND-100, an oral drug candidate aimed at treating Alcohol Use Disorder (AUD). This trial is being conducted at multiple sites, including Yale School of Medicine and Johns Hopkins University, and seeks to evaluate the safety and efficacy of the drug in reducing alcohol cravings. Clearmind has also expanded its trial by adding Hadassah-University Medical Center in Jerusalem and Tel Aviv Sourasky Medical Center as new clinical sites. The study’s expansion aims to deepen the scientific strength of the trial, which already includes several prestigious institutions. Additionally, Clearmind has engaged a government and political affairs consulting firm to help navigate regulatory frameworks for its psychedelic-based treatments. This move is part of the company’s strategy to integrate psychedelic therapies into mainstream healthcare. Clearmind’s intellectual portfolio includes nineteen patent families with 31 granted patents. The company is actively working to address the significant unmet medical needs of those affected by AUD.

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