Clearmind Medicine reports positive safety results for CMND-100 in treating Alcohol Use Disorder from its Phase I/IIa trial.
Quiver AI Summary
Clearmind Medicine Inc. announced positive safety results from the second cohort of its Phase I/IIa clinical trial for CMND-100, a non-hallucinogenic oral drug aimed at treating Alcohol Use Disorder (AUD). Following successful treatment completion of six additional patients, the results continue to demonstrate no serious adverse events and good tolerability, reinforcing earlier findings from the first cohort. Conducted at prestigious medical centers, the trial is designed to evaluate the safety and efficacy of CMND-100. CEO Dr. Adi Zuloff-Shani highlighted the importance of these results in establishing CMND-100 as a promising novel therapy for AUD, emphasizing its potential to address significant unmet health needs.
Potential Positives
- Additional positive safety topline results from the second cohort of Clearmind's Phase I/IIa clinical trial reinforce the encouraging safety and tolerability profile of CMND-100 for Alcohol Use Disorder (AUD).
- The trial showed no serious adverse events, contributing to a strong perception of the drug's safety among stakeholders and potential investors.
- The completion of treatment in the second cohort shortly after receiving Data and Safety Monitoring Board approval demonstrates the company's momentum and confidence in the trial's design and outcomes.
- Leading clinical sites, including Johns Hopkins University and Tel Aviv Sourasky Medical Center, are involved in the trial, enhancing the credibility and visibility of the research efforts undertaken by Clearmind Medicine.
Potential Negatives
- Despite the positive tone, the press release heavily relies on forward-looking statements that emphasize uncertainty, highlighting that there is no guarantee the positive safety profile will lead to successful outcomes in further trials or commercialization.
- The mention of risks and uncertainties affecting the company suggests vulnerability in its development pathway, which could deter potential investors concerned about the stability and viability of the company’s drug candidate.
- The company's focus on a non-hallucinogenic treatment for Alcohol Use Disorder may limit its appeal in a competitive market where other treatments, including psychedelic therapies, may show more promise or higher market demand.
FAQ
What is Clearmind Medicine Inc. focused on?
Clearmind Medicine Inc. focuses on discovering and developing novel neuroplastogen-derived therapeutics for under-treated health problems.
What are the latest results from Clearmind's clinical trial?
The latest results show positive safety topline results from the second cohort of the CMND-100 clinical trial for Alcohol Use Disorder.
What is CMND-100?
CMND-100 is a proprietary non-hallucinogenic MEAI-based oral drug candidate for treating Alcohol Use Disorder.
Where is the clinical trial for CMND-100 being conducted?
The trial is being conducted at notable sites including Johns Hopkins University and Hadassah Medical Center.
What is the safety profile of CMND-100?
CMND-100 has shown no serious adverse events and maintains a strong tolerability profile based on the trial results.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
Vancouver, Canada, Feb. 09, 2026 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the "Company"), a clinical-stage biotech company focused on the discovery and development of novel neuroplastogen-derived therapeutics to solve major under-treated health problems, today announced additional positive safety topline results from the second cohort of its ongoing FDA-approved Phase I/IIa clinical trial evaluating CMND-100, the Company’s proprietary non-hallucinogenic MEAI-based oral drug candidate, for the treatment of Alcohol Use Disorder (AUD).
These further safety data points, emerging following the successful completion of treatment in another six patients of the second cohort, previously announced January 14, 2026, continue to strengthen the encouraging safety and tolerability profile previously established in the first cohort.
The results reinforce no serious adverse events and overall good tolerability, consistent with the favorable results reported from the first cohort, support the rapid progression enabled by the Company’s Data and Safety Monitoring Board’s (DSMB) unanimous approval to advance for the second cohort.
The Phase I/IIa clinical trial is a multinational, multicenter study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of CMND-100 in patients with moderate to severe AUD. The second cohort, conducted across leading sites, including Johns Hopkins University, Tel Aviv Sourasky Medical Center, and Hadassah Medical Center, achieved full treatment completion shortly after DSMB clearance, underscoring continued confidence in CMND-100’s safety profile as a potential innovative therapy for AUD.
“These additional topline safety results from the second cohort further validate and reinforce the positive profile we observed in the first cohort,” said Dr. Adi Zuloff-Shani, Chief Executive Officer of Clearmind Medicine. “With no serious adverse events emerging and strong tolerability maintained, we are continuing to build compelling evidence for CMND-100 as a potentially safe, non-hallucinogenic, not adjunct to psychotherapy, treatment to address the significant unmet needs in alcohol use disorder.”
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
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Telephone: (604) 260-1566
US:
[email protected]
General Inquiries
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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 CMND-100’s safety profile as a potential innovative therapy for alcohol use disorder and how it is continuing to build compelling evidence for CMND-100 as a potentially safe, non-hallucinogenic, not adjunct to psychotherapy, treatment to address the significant unmet needs in 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, 2025 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.