Clearmind Medicine Successfully Completed First Cohort Treatment in its FDA-Approved Phase I/IIa Clinical Trial for Alcohol Use Disorder
Rhea-AI Summary
Clearmind Medicine (Nasdaq: CMND) announced completion of treatment for the first patient cohort in its ongoing FDA-approved Phase I/IIa trial of CMND-100 for Alcohol Use Disorder (AUD) on November 10, 2025. Six patients have been enrolled and treated to date, with two sites at Johns Hopkins and four at Yale, and two additional sites in Israel activated.
The multinational, multicenter single- and multiple-dose study will assess safety, tolerability, and pharmacokinetics and explore preliminary efficacy signals such as reductions in alcohol cravings and consumption among treatment-seeking and non-treatment-seeking heavy drinkers. The company highlighted the commercial context, citing a market projected to reach about $20 billion by 2032.
Positive
- First cohort completed with six patients treated
- Top research sites activated: Johns Hopkins and Yale enrollment
- Two additional sites in Israel activated for the trial
- Study scope includes single- and multiple-dose safety, tolerability, and PK
Negative
- Very small sample: only six patients treated to date
- Early-phase data limits conclusions on efficacy and commercial viability
- Selective enrollment requires participants to want to reduce/stop drinking, which may limit generalizability
News Market Reaction – CMND
On the day this news was published, CMND declined 0.79%, reflecting a mild negative market reaction. Argus tracked a trough of -41.8% from its starting point during tracking. Our momentum scanner triggered 37 alerts that day, indicating elevated trading interest and price volatility. This price movement removed approximately $29K from the company's valuation, bringing the market cap to $4M at that time. Trading volume was exceptionally heavy at 11.1x the daily average, suggesting significant selling pressure.
Data tracked by StockTitan Argus on the day of publication.
Milestone advances MEAI-based therapy targeting a global Alcohol Use Disorder treatment market projected to surpass
Vancouver, Canada, Nov. 10, 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 psychedelic-derived therapeutics to solve major under-treated health problems, recently announced that it has successfully completed treatment of the first patient cohort in its ongoing Phase I/IIa clinical trial evaluating CMND-100 for the treatment of Alcohol Use Disorder (AUD).
To date, six patients have been successfully enrolled and treated in the trial, with two patients enrolled at Johns Hopkins University School of Medicine and four patients enrolled at Yale School of Medicine’s Department of Psychiatry- two of the world’s leading centers for neuropsychiatric and addiction research, highlighting the high scientific and clinical standards guiding the study In addition, two additional sites in Israel have been activated for the Phase I/IIa clinical trial.
The multinational, multicenter Phase I/IIa trial is designed as a single- and multiple-dose study to assess the safety, tolerability, and pharmacokinetic profile of CMND-100. It will also explore preliminary efficacy signals, such as reductions in alcohol cravings and consumption, among participants who are either non-treatment-seeking individuals reporting heavy binge drinking or treatment-seeking individuals diagnosed with AUD per DSM-5 criteria. All participants must express a desire to reduce or stop drinking.
Following FDA Investigational New Drug (IND) approval, the trial represents a critical step in advancing CMND-100 as a potential innovative therapy for the hundreds of millions worldwide affected by AUD, a condition where current treatments often fall short. The need for more effective AUD treatments remains urgent. According to Data Bridge Market Research, the global alcohol-dependency treatment market was valued at approximately
“Completing the first cohort is an important milestone as we progress toward demonstrating the potential clinical benefits of CMND-100 for people living with alcohol use disorder,” said Dr. Adi Zuloff-Shani, Chief Executive Officer of Clearmind Medicine.
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 the expected growth of the global alcohol-dependency treatment market and its progress toward demonstrating the potential clinical benefits of CMND-100 for people living with alcohol use disorder. 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
How many patients has Clearmind (CMND) treated in its Phase I/IIa CMND-100 AUD trial as of November 10, 2025?
Which research centers enrolled patients in Clearmind's CMND-100 AUD trial (CMND)?
What endpoints is the CMND-100 Phase I/IIa trial (CMND) designed to assess?
Does Clearmind's CMND-100 AUD trial have FDA clearance (CMND)?
What is the significance of completing the first cohort in Clearmind's CMND-100 trial (CMND)?
