Clearmind Medicine Expands Global Clinical Trial Targeting Multibillion-Dollar Alcohol Use Disorder Market
Clearmind Medicine (Nasdaq: CMND) announced the expansion of its Phase I/IIa clinical trial for CMND-100, a MEAI-based oral drug candidate targeting Alcohol Use Disorder (AUD). The company has added Hadassah-University Medical Center in Jerusalem as a new trial site, joining prestigious institutions including Yale School of Medicine, Johns Hopkins University, Tel Aviv Sourasky Medical Center, and IMCA.
The trial aims to evaluate safety, tolerability, and pharmacokinetics of CMND-100, while exploring its potential to reduce alcohol cravings. The expansion targets the global AUD market affecting over 280 million people, representing a multibillion-dollar opportunity given current limited treatment options.
Clearmind Medicine (Nasdaq: CMND) ha annunciato l'espansione del suo studio clinico di Fase I/IIa per CMND-100, un candidato farmaco orale a base di MEAI destinato al trattamento del Disturbo da Uso di Alcol (AUD). L'azienda ha aggiunto come nuovo sito di sperimentazione il Hadassah-University Medical Center di Gerusalemme, che si unisce a istituzioni prestigiose come la Yale School of Medicine, la Johns Hopkins University, il Tel Aviv Sourasky Medical Center e IMCA.
Lo studio mira a valutare la sicurezza, tollerabilità e farmacocinetica di CMND-100, esplorandone al contempo il potenziale nel ridurre il desiderio di alcol. L'espansione si rivolge al mercato globale dell'AUD che coinvolge oltre 280 milioni di persone, rappresentando un'opportunità multimiliardaria vista la limitata disponibilità di trattamenti attuali.
Clearmind Medicine (Nasdaq: CMND) anunció la expansión de su ensayo clínico de Fase I/IIa para CMND-100, un candidato a medicamento oral basado en MEAI dirigido al Trastorno por Consumo de Alcohol (AUD). La compañía ha añadido el Hadassah-University Medical Center en Jerusalén como un nuevo sitio de ensayo, uniéndose a prestigiosas instituciones como la Yale School of Medicine, Johns Hopkins University, Tel Aviv Sourasky Medical Center e IMCA.
El ensayo tiene como objetivo evaluar la seguridad, tolerabilidad y farmacocinética de CMND-100, mientras explora su potencial para reducir los antojos de alcohol. La expansión apunta al mercado global del AUD que afecta a más de 280 millones de personas, representando una oportunidad multimillonaria dada la limitada disponibilidad de tratamientos actuales.
Clearmind Medicine (나스닥: CMND)는 알코올 사용 장애(AUD)를 표적으로 하는 MEAI 기반 경구 약물 후보인 CMND-100의 임상 1/2a상 시험 확장을 발표했습니다. 회사는 예일 의과대학, 존스 홉킨스 대학교, 텔아비브 수라스키 의료센터, IMCA 등 권위 있는 기관들과 함께 예루살렘의 Hadassah-University Medical Center를 새로운 시험 장소로 추가했습니다.
이번 시험은 CMND-100의 안전성, 내약성 및 약동학을 평가하는 동시에 알코올 갈망 감소 가능성을 탐구하는 것을 목표로 합니다. 이번 확장은 전 세계 2억 8천만 명 이상의 AUD 환자 시장을 대상으로 하며, 현재 제한된 치료 옵션으로 인해 수십억 달러 규모의 기회를 나타냅니다.
Clearmind Medicine (Nasdaq : CMND) a annoncé l'expansion de son essai clinique de phase I/IIa pour CMND-100, un candidat médicament oral à base de MEAI ciblant le trouble de l'usage d'alcool (AUD). La société a ajouté le Hadassah-University Medical Center de Jérusalem comme nouveau site d'essai, rejoignant des institutions prestigieuses telles que la Yale School of Medicine, l'Université Johns Hopkins, le Tel Aviv Sourasky Medical Center et l'IMCA.
L'essai vise à évaluer la sûreté, la tolérance et la pharmacocinétique de CMND-100, tout en explorant son potentiel à réduire les envies d'alcool. Cette expansion cible le marché mondial de l'AUD, qui touche plus de 280 millions de personnes, représentant une opportunité de plusieurs milliards de dollars compte tenu des options de traitement actuellement limitées.
Clearmind Medicine (Nasdaq: CMND) gab die Erweiterung seiner Phase I/IIa-Studie für CMND-100 bekannt, einem MEAI-basierten oralen Arzneimittelkandidaten zur Behandlung der Alkoholgebrauchsstörung (AUD). Das Unternehmen hat das Hadassah-University Medical Center in Jerusalem als neuen Studienstandort hinzugefügt, neben renommierten Einrichtungen wie der Yale School of Medicine, der Johns Hopkins University, dem Tel Aviv Sourasky Medical Center und IMCA.
Ziel der Studie ist es, die Sicherheit, Verträglichkeit und Pharmakokinetik von CMND-100 zu bewerten und gleichzeitig dessen Potenzial zur Reduktion von Alkoholverlangen zu erforschen. Die Erweiterung richtet sich an den globalen AUD-Markt, der über 280 Millionen Menschen betrifft, und stellt angesichts der derzeit begrenzten Behandlungsmöglichkeiten eine milliardenschwere Chance dar.
- Addition of prestigious Hadassah-University Medical Center enhances trial credibility
- Collaboration with leading global institutions including Yale and Johns Hopkins
- Targeting large market opportunity with over 280 million AUD patients globally
- Enhanced patient recruitment and data collection capabilities through site expansion
- Still in early clinical stages (Phase I/IIa)
- No efficacy data available yet
- Faces competition in multibillion-dollar AUD market
Insights
Clearmind's AUD trial expansion to Hadassah Medical Center strengthens credibility and accelerates their promising CMND-100 candidate's development timeline.
Clearmind Medicine's expansion of its CMND-100 clinical trial to include Hadassah-University Medical Center represents a strategic enhancement to their Phase I/IIa study. This addition brings their total to five prestigious research institutions across Israel and the US, including Yale and Johns Hopkins, significantly boosting the trial's scientific credibility.
The trial design is particularly comprehensive, evaluating not just safety and pharmacokinetics (typical Phase I endpoints), but also incorporating early efficacy signals by assessing alcohol craving reduction - effectively combining Phase I and IIa objectives. This efficient approach could accelerate development timelines if successful.
From a clinical perspective, the expansion serves three critical functions: 1) improving patient recruitment rates, 2) accelerating data collection, and 3) increasing statistical power - all crucial factors for trial success and regulatory consideration. The inclusion of multiple international sites also provides valuable diversity in the patient population.
CMND-100's focus on MEAI (5-methoxy-2-aminoindane) represents an innovative approach to AUD treatment. Unlike traditional therapies that often rely on aversion mechanisms or opioid antagonists, psychedelic-derived compounds may address the neurobiological drivers of addiction through novel pathways, potentially offering improved efficacy with fewer side effects.
With 280 million people affected by AUD globally and limited effective treatments, CMND-100 targets a significant unmet medical need. However, the compound remains in early clinical development, with substantial regulatory hurdles ahead before potential commercialization.
The expansion of Clearmind's AUD clinical trial network significantly enhances their competitive positioning in the multibillion-dollar alcohol addiction treatment market. By adding Hadassah-University Medical Center to their already impressive roster of research institutions, they've created one of the most academically credentialed early-phase trials in the addiction space.
This institutional network provides three key strategic advantages: First, it creates a powerful validation mechanism, with multiple respected centers independently evaluating their compound. Second, it establishes valuable relationships with key opinion leaders who can influence future prescribing patterns. Third, it creates geographic diversity that will be appealing to potential pharmaceutical partners looking for global market access.
The global AUD treatment market represents a substantial commercial opportunity due to three factors: 1) enormous patient population (280 million affected individuals), 2) chronic nature of the condition requiring ongoing treatment, and 3) significant dissatisfaction with current therapeutic options. Existing AUD medications suffer from limited efficacy, poor compliance, and side effect profiles that restrict widespread adoption.
CMND-100's psychedelic-derived approach positions it within an emerging therapeutic class that has attracted significant investor and pharmaceutical interest. Recent psychedelic medicine acquisitions have commanded substantial premiums, reflecting industry confidence in the sector's potential.
While promising, Clearmind faces standard biopharma development risks including clinical trial outcomes, regulatory approval pathways, and potential competition from other novel approaches targeting addiction. Their current clinical phase suggests commercialization remains several years away, assuming positive trial results.
Vancouver, Canada, June 27, 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 addition of Hadassah-University Medical Center, Jerusalem, Israel, as a new clinical site for its ongoing Phase I/IIa clinical trial evaluating CMND-100, a proprietary MEAI-based oral drug candidate, for the treatment of Alcohol Use Disorder (AUD).
The trial site at Hadassah-University Medical Center will be led by Prof. Yossi Karko, Director of the Center for Clinical Research, joining other prestigious institutions participating in the trial, including Yale School of Medicine’s Department of Psychiatry and Johns Hopkins University School of Medicine in the United States, as well as Tel Aviv Sourasky Medical Center (Ichilov) and IMCA in Israel.
The ongoing first-in-human trial is designed to evaluate the safety, tolerability, and pharmacokinetics of CMND-100, while also exploring its potential to reduce alcohol cravings and consumption in individuals diagnosed with AUD. The inclusion of additional leading institutions is expected to enhance patient recruitment, accelerate data collection, and increase the statistical power of the study.
Alcohol Use Disorder affects over 280 million people globally, representing a significant unmet medical need and a potential multibillion-dollar market opportunity. Despite its prevalence, current treatment options are limited in efficacy and adoption, creating strong demand for novel, evidence-based solutions.
“We are honored to welcome Hadassah-University Medical Center to our Phase I/IIa clinical trial, alongside several of the most renowned global institutions, which we believe is further validation of CMND-100’s potential,” said Dr. Adi Zuloff-Shani, CEO of Clearmind Medicine. “This addition deepens the scientific strength of our trial and supports our mission to deliver a novel therapeutic option for the hundreds of millions of individuals around the world facing the devastating impact alcohol dependence can have on both them and their families.”
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 how the inclusion of additional leading institutions in the clinical trial is expected to enhance patient recruitment, accelerate data collection, and increase the statistical power of the study, the potential multibillion-dollar market opportunity for Alcohol Use Disorder treatments and the Company’s mission to deliver a novel therapeutic option for the hundreds of millions of individuals around the world facing the devastating impact alcohol dependence can have on both them and their families. 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.
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