Clearmind Medicine Charges Forward in Alcoholism Treatment: Positive Cohort Data, Full DSMB Approval, and New Elite Site Joins the Clinical Trial
Rhea-AI Summary
Clearmind Medicine (Nasdaq: CMND) announced three clinical milestones for its MEAI-based oral therapy CMND-100 targeting Alcohol Use Disorder: positive top-line safety and preliminary efficacy data from the trial's first cohort of six participants (reported Nov 18, 2025); a unanimous independent DSMB recommendation to continue following an unblinded safety review (Nov 24, 2025); and activation of a new Israeli site, Tel Aviv Sourasky Medical Center, with first patient enrolled (Nov 25, 2025), joining Yale, Johns Hopkins and Hadassah sites. The Phase I/IIa trial evaluates safety, tolerability, pharmacokinetics and preliminary efficacy and the new site may accelerate multinational recruitment for subsequent phases.
Positive
- Top-line positive safety and preliminary efficacy in a 6-patient cohort (Nov 18, 2025)
- Unanimous DSMB recommendation to continue after unblinded review (Nov 24, 2025)
- Tel Aviv Sourasky Medical Center site activated with first patient enrolled (Nov 25, 2025)
- Multiple elite investigator sites active: Yale, Johns Hopkins, Hadassah, TASMC
Negative
- Initial cohort size was only 6 participants, limiting statistical strength
Insights
Positive early signals: small first cohort reported favorable top-line data, DSMB cleared continuation, and a new Israeli site began enrollment.
Clearmind’s CMND-100 reported favorable top-line results from a six-person first cohort and received a unanimous independent DSMB recommendation to continue following an unblinded safety review on
Key dependencies and risks include the very small initial sample (six participants) and the interim nature of the data; the DSMB’s unanimous approval confirms no immediate safety halt but does not imply efficacy at scale. Trial progress depends on continued clean safety reviews, consistent enrollment across sites, and completion of planned pharmacokinetic and efficacy endpoints in later cohorts. Watch the next cohort readouts, subsequent DSMB communications, and enrollment cadence through
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
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:
Investor Relations
invest@clearmindmedicine.com
Telephone: (604) 260-1566
US: CMND@crescendo-ir.com
General Inquiries
Info@Clearmindmedicine.com
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.
FAQ
What did Clearmind (CMND) report about the first cohort of CMND-100 on November 18, 2025?
What did the DSMB conclude about Clearmind's Phase I/IIa trial on November 24, 2025?
Which new clinical site did Clearmind activate for CMND-100 and when was the first patient enrolled?
How might the new TASMC site affect CMND-100 clinical trial recruitment for CMND?
What endpoints is the Phase I/IIa CMND-100 trial evaluating for CMND?
Which leading institutions are participating in the CMND-100 trial for CMND?
