Clearmind Medicine Completes Initiation of Leading Israeli Clinical Site for Phase I/IIa Trial of CMND-100 in Alcohol Use Disorder
Rhea-AI Summary
Clearmind Medicine (Nasdaq: CMND) has successfully completed site initiation at Tel Aviv Sourasky Medical Center (TASMC) for its Phase I/IIa clinical trial of CMND-100, a novel oral drug candidate for Alcohol Use Disorder (AUD). The trial is being conducted across multiple prestigious institutions, including Yale School of Medicine, Johns Hopkins University, and Israeli medical centers.
The study aims to evaluate the safety, tolerability, and pharmacokinetic profile of CMND-100, while also assessing early efficacy signals in reducing alcohol cravings and consumption. The drug candidate utilizes 5-methoxy-2-aminoindane (MEAI) to potentially treat AUD, which currently affects millions globally and causes 2.6 million deaths annually.
Positive
- Expansion of clinical trial to prestigious medical centers including Yale, Johns Hopkins, and TASMC
- Promising preclinical results showing potential reduction in alcohol cravings
- Addressing a significant global market with 2.6 million annual deaths from AUD
- Development of non-hallucinogenic treatment option for AUD
Negative
- Early-stage clinical trial with no efficacy data yet available
- Complex multinational trial coordination across multiple centers may impact timeline
Insights
Clearmind's AUD drug CMND-100 expands Phase I/IIa trial to Tel Aviv Sourasky Medical Center, strengthening its multi-center approach investigating a novel non-hallucinogenic MEAI treatment.
Clearmind Medicine has successfully expanded its Phase I/IIa clinical trial for CMND-100 by completing site initiation at Tel Aviv Sourasky Medical Center (TASMC). This site joins an impressive roster of research institutions including Yale, Johns Hopkins, and Hadassah Medical Center, creating a robust multinational clinical network for their Alcohol Use Disorder (AUD) treatment candidate.
The trial has dual objectives: primarily evaluating safety, tolerability, and pharmacokinetics of CMND-100, while simultaneously collecting preliminary efficacy data on alcohol craving reduction and consumption patterns. This hybrid Phase I/IIa design is strategically efficient, potentially accelerating the development timeline by capturing both safety and early efficacy signals in a single study.
CMND-100's active ingredient, 5-methoxy-2-aminoindane (MEAI), represents an interesting mechanistic approach. Unlike traditional AUD medications that typically work through aversion therapy (disulfiram), opioid antagonism (naltrexone), or GABA modulation (acamprosate), MEAI appears to target alcohol cravings directly. Notably, the company emphasizes its non-hallucinogenic properties, differentiating it from classic psychedelics while still leveraging novel CNS pathways.
The clinical significance is substantial considering AUD's global impact, which causes 2.6 million deaths annually. With few effective pharmacotherapies available and high treatment discontinuation rates, the medical need remains critically underserved. Adding TASMC expands patient recruitment capacity, potentially accelerating study completion and advancing the program toward pivotal trials if early results prove promising.
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Vancouver, Canada, July 23, 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, today announced the successful completion of site initiation at Tel Aviv Sourasky Medical Center (TASMC) for its Phase I/IIa clinical trial evaluating CMND-100, a proprietary oral drug candidate for Alcohol Use Disorder (AUD). This milestone advances Clearmind’s mission to transform treatment for the global epidemic of AUD, which affects millions and accounts for 2.6 million deaths annually.
The Phase I/IIa trial, already underway at prestigious sites, including Yale School of Medicine and Johns Hopkins University in the United States and TASMC and Hadassah-University Medical Center in Israel, is a multinational, multi-center study assessing the safety, tolerability, and pharmacokinetic profile of CMND-100. It also explores early efficacy signals, such as reduced alcohol cravings and consumption, in patients with AUD. The inclusion of TASMC as a clinical site, where the trial is led by Prof. David Zeltser, Director of the Emergency Medicine Department at TASMC, strengthens Clearmind’s clinical network and accelerates patient enrollment in this groundbreaking trial.
“We are thrilled to complete the initiation of Tel Aviv Sourasky Medical Center, a world-class institution, in our Phase I/IIa trial for CMND-100,” said Dr. Adi Zuloff-Shani, CEO of Clearmind Medicine. “This milestone brings us closer to potentially delivering an innovative, non-hallucinogenic treatment for AUD, addressing a critical unmet need for millions worldwide. We believe that our collaboration with leading centers like TASMC, Hadassah, Yale, and Johns Hopkins underscores the scientific community’s confidence in our approach.”
CMND-100, Clearmind’s lead compound, leverages the innovative molecule 5-methoxy-2-aminoindane (MEAI) to offer a potential breakthrough in AUD treatment. Preclinical studies have shown promising results in reducing alcohol cravings, positioning CMND-100 as a potentially novel therapeutic in a market with significant demand.
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 Company’s mission to transform treatment for the global epidemic of AUD, which affects millions and accounts for 2.6 million deaths annually, potentially delivering an innovative, non-hallucinogenic treatment for AUD, addressing a critical unmet need for millions worldwide, the scientific community’s confidence in the Company’s approach, how preclinical studies have shown promising results in reducing alcohol cravings and CMND-100’s position as a potential novel therapeutic in a market with significant demand. 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.
