Clearmind Medicine Charges Forward in Alcoholism Treatment: Positive Cohort Data, Full DSMB Approval, and New Elite Site Joins the Clinical Trial
Vancouver, Canada, Dec. 01, 2025 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (NASDAQ:CMND), (FSE: CWY0) ("Clearmind" or the "Company"), a clinical-stage biotech company focused on discovery and development of novel neuroplastogen-derived therapeutics to solve major under-treated health problems, recently announced three transformative milestones in its FDA-approved Phase I/IIa clinical trial for CMND-100—the Company's proprietary, non-hallucinogenic, MEAI-based oral therapy targeting Alcohol Use Disorder (AUD).
These achievements include positive top-line results from the first cohort, unanimous approval from the independent Data and Safety Monitoring Board (DSMB) to continue Phase I/IIa clinical trial and the commencement of enrollment at another clinical site in Israel, propelling the multinational study toward potential accelerated patient recruitment.
AUD impacts over 28 million adults in the U.S. alone, driving staggering societal and economic costs exceeding $249 billion annually, yet current treatments fall short in efficacy and accessibility. Clearmind's CMND-100, designed to safely and effectively diminish alcohol cravings and consumption through innovative neuroplasticity mechanisms. The ongoing trial—a single- and multiple-dose evaluation of safety, tolerability, pharmacokinetics, and preliminary efficacy—spans world-renowned institutions.
Positive Safety and Efficacy Results from First Cohort
In an announcement on November 18, the Company reported compelling top-line data from the trial's initial cohort of six participants Who were dosed across elite sites including Johns Hopkins University School of Medicine (two participants) and Yale School of Medicine's Department of Psychiatry (four participants).
DSMB's Resounding Green Light Fuels Momentum
Building on this momentum, Clearmind's independent DSMB conducted a meticulous, unblinded interim safety review on November 24. The board unanimously recommended that the clinical trial continue.
Global Network Expands with Elite Israeli Site Activation
Just one day later, on November 25, Clearmind activated enrollment at another clinical site in its international consortium: Tel Aviv Sourasky Medical Center (TASMC), one of Israel's leading medical centers. Under the leadership of Principal Investigator Prof. David Zeltser, Director of Internal Medicine and Deputy Director of R&D and Innovation, TASMC welcomed its first patient—marking seamless site initiation and injecting fresh velocity into recruitment efforts. This joins an elite lineup of active centers, including Yale School of Medicine, Johns Hopkins University School of Medicine, and Hadassah Medical Center, enabling diverse, high-quality data accrual to power the trial's next phases.
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."
For further information visit: https://www.clearmindmedicine.com or contact:
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www.Clearmindmedicine.com
Forward-Looking Statements:
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses potential accelerated patient recruitment in its Phase I/IIa clinical trial and the timing and progress of its clinical trial. Forward-looking statements are not historical facts, and are based upon management's current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management's expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company's reports filed from time to time with the Securities and Exchange Commission ("SEC"), including, but not limited to, the risks detailed in the Company's annual report on Form 20-F for the fiscal year ended October 31, 2024 and subsequent filings with the SEC. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Clearmind is not responsible for the contents of third-party websites.
