Clearmind Medicine Enrolls First Patient in its Clinical Trial for Alcoholism Treatment
Rhea-AI Summary
Clearmind Medicine (NASDAQ: CMND) has announced the enrollment of its first patient in a Phase I/IIa clinical trial for CMND-100, their MEAI-based oral drug candidate for treating Alcohol Use Disorder (AUD). The trial, conducted at Yale School of Medicine's Department of Psychiatry and Johns Hopkins University, will evaluate the drug's safety, tolerability, and pharmacokinetic profile.
The study targets individuals aged 18-60 who either report heavy binge drinking or are diagnosed with AUD. The U.S. substance use disorder treatment market, valued at $35.1 billion in 2021, is projected to reach $60.2 billion by 2029. The company aims to address limitations in current AUD treatments, which have shown limited effectiveness and adverse side effects.
Positive
- First patient enrolled in Phase I/IIa clinical trial for CMND-100, marking significant milestone
- Trial conducted at prestigious institutions Yale and Johns Hopkins
- Targeting large market opportunity - U.S. substance use disorder treatment market projected to reach $60.2B by 2029
- Addresses significant unmet medical need with potential advantages over current treatment options
Negative
- Early-stage clinical trial with no efficacy data yet
- Will require significant time and resources to complete clinical development
- Faces competition in large but challenging market
Insights
Clearmind's first patient enrollment for CMND-100 marks crucial clinical milestone in AUD treatment development with significant market potential.
Clearmind Medicine has achieved a significant clinical milestone with the enrollment of its first patient in the Phase I/IIa trial for CMND-100, their proprietary MEAI-based oral drug candidate targeting Alcohol Use Disorder (AUD). This first-in-human study is being conducted at prestigious institutions including Yale School of Medicine and Johns Hopkins University, lending scientific credibility to the program.
The trial design is methodologically sound, targeting both treatment-seeking AUD patients and non-treatment-seeking heavy drinkers, with clear inclusion criteria focused on binge drinking patterns. This dual-population approach is strategically valuable as it will provide data across a spectrum of alcohol use behaviors, potentially broadening the eventual therapeutic application.
What makes CMND-100 particularly noteworthy is its psychedelic-derived mechanism targeting an indication with significant unmet need. Current AUD treatments suffer from limited efficacy and problematic side effects, creating a substantial market opportunity. The company correctly identifies the
For a clinical-stage biotech, first patient enrollment represents the transition from preclinical promise to human proof-of-concept. While still early-stage (Phase I/IIa), this milestone reduces some developmental risk and begins the critical safety and preliminary efficacy assessment that will determine the compound's future. The inclusion of pharmacokinetic analysis will provide crucial data on how CMND-100 is processed in the human body, essential information for dose optimization in future trials.
CMND-100 has the potential to provide an innovative and advanced treatment option for hundreds of millions of people around the world afflicted with Alcohol Use Disorder
Vancouver, Canada, June 25, 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 the enrollment of the first patient in its Phase I/IIa clinical trial for CMND-100, the Company’s proprietary MEAI-based oral drug candidate for the treatment of Alcohol Use Disorder (AUD).
The first patient was enrolled at Yale School of Medicine’s Department of Psychiatry, marking a significant milestone in the trial.
The trial is evaluating the safety, tolerability, and pharmacokinetic profile of CMND-100, with preliminary efficacy assessments to explore its potential in reducing alcohol cravings and consumption. This first-in-human study represents a pivotal step toward developing a groundbreaking treatment for individuals struggling with AUD.
Eligible subjects for the clinical trial, among others, are individuals aged 18 to 60. Participants may be either non-treatment-seeking individuals who report heavy binge drinking (defined as at least five standard drinks in a day for men or at least four for women) on at least five days in the past month prior to screening, or treatment-seeking individuals diagnosed with Alcohol Use Disorder (AUD) per DSM-5 criteria, who report at least four binge drinking days in the month prior to screening. All subjects must express a desire to reduce or stop drinking. For more information: https://clinicaltrials.gov/study/NCT05913752?spons=Clearmind%20Medicine%20Inc.&rank=1#study-overview
Dr. Adi Zuloff-Shani, CEO of Clearmind Medicine said:”This advancement brings us one step closer to offering an innovative solution for those affected by AUD, a condition with significant unmet medical needs. The substance use disorder treatment market in the U.S. alone was valued at
The Phase I/IIa clinical trial is being conducted at multiple sites, including Yale School of Medicine and Johns Hopkins University School of Medicine, while the Company is valuating additional clinical sites. Clearmind remains committed to advancing its robust intellectual property portfolio and pioneering psychedelic-derived therapeutics to address global health challenges.
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 conducting its Phase I/IIa clinical trial, developing a treatment for individuals struggling with AUD, the size of the substance use disorder treatment market, executing its development strategy, valuating additional clinical sites, and that it remains committed to advancing its robust intellectual property portfolio and pioneering psychedelic-derived therapeutics to address global health challenges. The Company cannot assure that any patent will issue as a result of a pending patent application or, if issued, whether it will issue in a form that will be advantageous to the Company. 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 is the status of Clearmind Medicine's (CMND) clinical trial for alcoholism treatment?
Who is eligible for Clearmind Medicine's (CMND) alcoholism treatment trial?
What is the market potential for Clearmind Medicine's (CMND) alcoholism treatment?
Where is Clearmind Medicine (CMND) conducting its clinical trial?
What is the purpose of Clearmind Medicine's (CMND) CMND-100 trial?
