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Clearmind Medicine Completes Initiation of Leading Israeli Clinical Site for Phase I/IIa Trial of CMND-100 in Alcohol Use Disorder

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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.

Clearmind Medicine (Nasdaq: CMND) ha completato con successo l'avvio del sito presso il Tel Aviv Sourasky Medical Center (TASMC) per il suo trial clinico di Fase I/IIa su CMND-100, un nuovo candidato farmaco orale per il Disturbo da Uso di Alcol (AUD). Lo studio viene condotto in diversi istituti prestigiosi, tra cui la Yale School of Medicine, la Johns Hopkins University e centri medici israeliani.

L'obiettivo dello studio è valutare la sicurezza, la tollerabilità e il profilo farmacocinetico di CMND-100, oltre a rilevare i primi segnali di efficacia nella riduzione del desiderio e del consumo di alcol. Il candidato farmaco utilizza 5-metossi-2-aminoindano (MEAI) come potenziale trattamento per l'AUD, che attualmente colpisce milioni di persone nel mondo e provoca 2,6 milioni di decessi ogni anno.

Clearmind Medicine (Nasdaq: CMND) ha completado con éxito la iniciación del sitio en el Tel Aviv Sourasky Medical Center (TASMC) para su ensayo clínico de Fase I/IIa de CMND-100, un nuevo candidato oral para el Trastorno por Consumo de Alcohol (AUD). El estudio se está llevando a cabo en varias instituciones prestigiosas, incluyendo la Escuela de Medicina de Yale, la Universidad Johns Hopkins y centros médicos israelíes.

El estudio tiene como objetivo evaluar la seguridad, tolerabilidad y perfil farmacocinético de CMND-100, además de valorar señales tempranas de eficacia para reducir los antojos y el consumo de alcohol. El candidato utiliza 5-metoxi-2-aminoindano (MEAI) para tratar potencialmente el AUD, que actualmente afecta a millones en todo el mundo y causa 2,6 millones de muertes anuales.

Clearmind Medicine (나스�: CMND)가 텔아비브 수라스키 의료센터(TASMC)에서 CMND-100� 대� 1/2a� 임상시험 사이� 개시� 성공적으� 완료했습니다. � 경구� 신약 후보물질은 알코� 사용 장애(AUD)� 대상으� 하며, 예일 의과대�, 존스 홉킨� 대학교 � 여러 명성 있는 기관� 이스라엘 의료기관에서 진행되고 있습니다.

이번 연구� CMND-100� 안전�, 내약�, 약동학적 특성� 평가하는 동시� 음주 욕구 � 섭취 감소� 대� 초기 효능 신호� 확인하는 것을 목표� 합니�. � 약물 후보� 5-메�-2-아미Ƹ인�(ѷ)� 활용하여 � 세계 수백� 명에� 영향� 미치� 연간 260� 명의 사망� 초래하는 AUD� 치료� 가능성� 탐구합니�.

Clearmind Medicine (Nasdaq : CMND) a achevé avec succès l'initiation du site au Tel Aviv Sourasky Medical Center (TASMC) pour son essai clinique de phase I/IIa de CMND-100, un nouveau candidat médicament oral pour le trouble lié à l'usage d'alcool (AUD). L'essai est mené dans plusieurs institutions prestigieuses, dont la Yale School of Medicine, l'Université Johns Hopkins et des centres médicaux israéliens.

Cette étude vise à évaluer la sécurité, la tolérabilité et le profil pharmacocinétique de CMND-100, tout en examinant les premiers signes d'efficacité dans la réduction des envies et de la consommation d'alcool. Le candidat médicament utilise le 5-méthoxy-2-aminoindane (MEAI) pour traiter potentiellement l'AUD, qui touche actuellement des millions de personnes dans le monde et cause 2,6 millions de décès par an.

Clearmind Medicine (Nasdaq: CMND) hat die Standortfreigabe am Tel Aviv Sourasky Medical Center (TASMC) für seine Phase I/IIa klinische Studie mit CMND-100, einem neuartigen oralen Arzneimittelkandidaten zur Behandlung der Alkoholkonsumstörung (AUD), erfolgreich abgeschlossen. Die Studie wird an mehreren renommierten Institutionen durchgeführt, darunter die Yale School of Medicine, Johns Hopkins University und israelische medizinische Zentren.

Ziel der Studie ist es, die Sicherheit, Verträglichkeit und das pharmakokinetische Profil von CMND-100 zu bewerten und gleichzeitig erste Wirksamkeitssignale zur Verringerung von Alkoholverlangen und -konsum zu erfassen. Der Wirkstoffkandidat nutzt 5-Methoxy-2-Aminoindan (MEAI) zur potenziellen Behandlung von AUD, das weltweit Millionen Menschen betrifft und jährlich 2,6 Millionen Todesfälle verursacht.

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.

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 .

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:  or contact:

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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.


FAQ

What is the purpose of Clearmind Medicine's CMND-100 Phase I/IIa clinical trial?

The trial aims to evaluate the safety, tolerability, and pharmacokinetic profile of CMND-100 for Alcohol Use Disorder (AUD), while also exploring early efficacy signals in reducing alcohol cravings and consumption.

Which medical centers are participating in Clearmind Medicine's Phase I/IIa trial?

The trial is being conducted at Yale School of Medicine, Johns Hopkins University in the US, and Tel Aviv Sourasky Medical Center and Hadassah-University Medical Center in Israel.

What is CMND-100 and how does it work?

CMND-100 is a proprietary oral drug candidate that uses 5-methoxy-2-aminoindane (MEAI) to potentially treat Alcohol Use Disorder. It's designed as a non-hallucinogenic treatment to reduce alcohol cravings.

What is the market potential for Clearmind Medicine's AUD treatment?

The treatment addresses a significant global health problem, with Alcohol Use Disorder contributing to 2.6 million deaths annually, representing a substantial market opportunity.

Who is leading the clinical trial at Tel Aviv Sourasky Medical Center?

The trial at TASMC is led by Prof. David Zeltser, Director of the Emergency Medicine Department.
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