Clearmind Medicine Announces Additional Topline Positive Safety Results Reinforcing Favorable Profile of CMND-100 in Ongoing Phase I/IIa Clinical Trial
MWN-AI** Summary
Clearmind Medicine Inc. (Nasdaq: CMND) recently announced positive safety topline results from the second cohort of its FDA-approved Phase I/IIa clinical trial for CMND-100, a non-hallucinogenic oral drug aimed at treating Alcohol Use Disorder (AUD). Conducted at renowned centers, including Johns Hopkins University, these results mark a continuation of the strong safety profile established in the first cohort, with no serious adverse events reported.
The trial, involving patients with moderate to severe AUD, is designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of CMND-100. The positive outcomes from this second cohort further validate the company's findings, reinforcing the drug's high tolerability and safety. Clearmind's Data and Safety Monitoring Board (DSMB) unanimously approved moving forward with this cohort, indicating confidence in the drug's profile.
Dr. Adi Zuloff-Shani, Clearmind's CEO, emphasized the significance of these results, highlighting the potential of CMND-100 as a safe, non-hallucinogenic treatment for AUD, independent of psychotherapy. The increased data supports the ongoing mission to address the considerable unmet needs presented by alcohol use disorder, an area that has long required innovative solutions.
Clearmind Medicine is focused on the development of neuroplastogen-derived therapeutics, with a goal of tackling various under-treated health issues. The company's intellectual property portfolio includes 19 patent families with 31 granted patents, reflecting its commitment to expanding its innovations in psychedelic medicine.
As Clearmind progresses in its clinical trials, the positive topline results from this latest cohort are likely to bolster investor confidence and interest in the company's potential role in transforming the treatment landscape for alcohol use disorder and beyond.
MWN-AI** Analysis
Clearmind Medicine Inc. (Nasdaq: CMND), a clinical-stage biotech company, has announced further positive safety results from its Phase I/IIa clinical trial for CMND-100, targeting Alcohol Use Disorder (AUD). The latest topline data reaffirms earlier findings, demonstrating no serious adverse events and solid tolerability among patients, paving the way for advancement in clinical trials.
Investors should approach CMND with cautious optimism. The ongoing success in clinical trials could position Clearmind as a key player in the treatment of AUD, an area with substantial unmet needs. The fact that the trial has been conducted at respected institutions such as Johns Hopkins University lends credibility to the research and could enhance investor confidence. Additionally, with a growing intellectual portfolio including 31 granted patents, Clearmind displays a strong commitment to developing a proprietary therapeutic landscape.
However, while the safety results are encouraging, potential investors must consider the inherent risks of biotech investments. Clinical trials can yield unexpected outcomes, particularly regarding efficacy, which has yet to be confirmed in this phase. Moreover, regulatory hurdles could arise as the company moves toward commercialization. Clearmind has highlighted its intellectual property strategy, suggesting a proactive approach to bolster its market position, but future patent approvals and broader market dynamics in the pharmaceutical sector remain uncertain.
In summary, while the positive safety results present a compelling case for Clearmind Medicine, those interested in CMND stock should closely monitor the progression of the clinical trials and remain aware of the broader risks associated with biotech investments. Diversifying or employing a cautious investment strategy may mitigate potential volatility as the company navigates these critical phases.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news 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
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 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.
FAQ**
What are the next steps for Clearmind Medicine Inc. (CMND) following the positive safety results from the Phase I/IIa trials for CMND-100 in treating alcohol use disorder (AUD)?
How do the latest findings from Clearmind Medicine Inc. (CMND) impact the company’s strategy for further developing neuroplastogen-derived therapeutics?
What are the implications of CMND-100's positive safety profile for Clearmind Medicine Inc. (CMND) in the competitive landscape of addiction treatment innovations?
How does Clearmind Medicine Inc. (CMND) plan to leverage its patent portfolio in the commercialization of CMND-100 and similar neuroplastogen-derived therapies?
**MWN-AI FAQ is based on asking OpenAI questions about Clearmind Medicine Inc. (NASDAQ: CMND).
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