Clearmind Medicine Receives IRB Approval for Phase 1/2a Clinical Trial for Alcohol Use Disorder at Hadassah Medical Center
Clearmind Medicine (NASDAQ: CMND) has received Institutional Review Board (IRB) approval from Hadassah Medical Center for its Phase 1/2a clinical trial of CMND-100, a MEAI-based oral drug candidate for Alcohol Use Disorder (AUD). This approval follows FDA IND clearance and enables patient enrollment at the Jerusalem-based facility.
The multinational, multi-center trial will be conducted at several prestigious institutions, including Yale School of Medicine, Johns Hopkins University, and Tel Aviv Sourasky Medical Center. The study aims to evaluate CMND-100's safety, tolerability, pharmacokinetic profile, and preliminary efficacy in reducing alcohol cravings and consumption in AUD patients.
The trial addresses a significant global health issue, as AUD accounts for 4.7% of worldwide deaths according to WHO data.
Clearmind Medicine (NASDAQ: CMND) ha ottenuto l'approvazione da parte del Comitato Etico (IRB) del Hadassah Medical Center per il suo studio clinico di fase 1/2a su CMND-100, un candidato farmaco orale a base di MEAI per il Disturbo da Uso di Alcol (AUD). Questa approvazione segue l'autorizzazione IND della FDA e permette l'arruolamento dei pazienti presso la struttura di Gerusalemme.
Lo studio multinazionale e multicentrico sarà condotto in diverse istituzioni prestigiose, tra cui la Yale School of Medicine, la Johns Hopkins University e il Tel Aviv Sourasky Medical Center. L'obiettivo è valutare la sicurezza, la tollerabilità, il profilo farmacocinetico e l'efficacia preliminare di CMND-100 nel ridurre il desiderio e il consumo di alcol nei pazienti con AUD.
La sperimentazione affronta un importante problema di salute globale, dato che l'AUD è responsabile di circa il 4,7% dei decessi mondiali secondo i dati dell'OMS.
Clearmind Medicine (NASDAQ: CMND) ha recibido la aprobación del Comité de Revisión Institucional (IRB) del Hadassah Medical Center para su ensayo clínico de fase 1/2a de CMND-100, un candidato a medicamento oral basado en MEAI para el Trastorno por Consumo de Alcohol (AUD). Esta aprobación sigue a la autorización IND de la FDA y permite la inscripción de pacientes en la instalación ubicada en Jerusalén.
El ensayo multinacional y multicéntrico se llevará a cabo en varias instituciones prestigiosas, incluyendo la Escuela de Medicina de Yale, la Universidad Johns Hopkins y el Centro Médico Tel Aviv Sourasky. El estudio tiene como objetivo evaluar la seguridad, tolerabilidad, perfil farmacocinético y la eficacia preliminar de CMND-100 para reducir los antojos y el consumo de alcohol en pacientes con AUD.
El ensayo aborda un problema importante de salud global, ya que el AUD representa aproximadamente el 4,7% de las muertes a nivel mundial según datos de la OMS.
Clearmind Medicine (NASDAQ: CMND)가 Hadassah Medical Center로부터 CMND-100의 1/2a상 임상시험에 대한 기관심사위원회(IRB) 승인을 받았습니다. CMND-100은 알코올 사용 장애(AUD)를 위한 MEAI 기반 경구 약물 후보입니다. 이 승인은 FDA IND 승인에 이은 것으로, 예루살렘 소재 시설에서 환자 등록을 가능하게 합니다.
이 다국적 다기관 임상시험은 예일 의과대학, 존스 홉킨스 대학교, 텔아비브 소라스키 의료센터 등 여러 명망 있는 기관에서 진행됩니다. 연구는 CMND-100의 안전성, 내약성, 약동학적 특성 및 AUD 환자의 알코올 갈망과 소비 감소에 대한 초기 효능을 평가하는 것을 목표로 합니다.
이 임상시험은 WHO 데이터에 따르면 AUD가 전 세계 사망의 약 4.7%를 차지하는 중요한 글로벌 보건 문제를 다루고 있습니다.
Clearmind Medicine (NASDAQ : CMND) a obtenu l'approbation du comité d'éthique institutionnel (IRB) du Hadassah Medical Center pour son essai clinique de phase 1/2a portant sur CMND-100, un candidat médicament oral à base de MEAI destiné au trouble de l'usage de l'alcool (AUD). Cette approbation fait suite à l'autorisation IND de la FDA et permet le recrutement des patients dans l'établissement de Jérusalem.
Cet essai multinational et multicentrique sera mené dans plusieurs institutions prestigieuses, notamment la Yale School of Medicine, l'Université Johns Hopkins et le centre médical Tel Aviv Sourasky. L'étude vise à évaluer la sécurité, la tolérance, le profil pharmacocinétique et l'efficacité préliminaire de CMND-100 dans la réduction des envies et de la consommation d'alcool chez les patients atteints d'AUD.
L'essai répond à un enjeu majeur de santé publique mondiale, puisque l'AUD représente environ 4,7 % des décès dans le monde selon les données de l'OMS.
Clearmind Medicine (NASDAQ: CMND) hat die Genehmigung des Institutional Review Board (IRB) des Hadassah Medical Center für seine Phase-1/2a-Studie zu CMND-100, einem auf MEAI basierenden oralen Arzneimittelkandidaten zur Behandlung der Alkoholkonsumstörung (AUD), erhalten. Diese Genehmigung folgt auf die IND-Freigabe der FDA und ermöglicht die Patientenaufnahme in der Einrichtung in Jerusalem.
Die multinationale, multizentrische Studie wird an mehreren renommierten Institutionen durchgeführt, darunter die Yale School of Medicine, Johns Hopkins University und das Tel Aviv Sourasky Medical Center. Ziel der Studie ist es, die Sicherheit, Verträglichkeit, das pharmakokinetische Profil sowie die vorläufige Wirksamkeit von CMND-100 bei der Verringerung von Alkoholverlangen und -konsum bei AUD-Patienten zu bewerten.
Die Studie adressiert ein bedeutendes globales Gesundheitsproblem, da AUD laut WHO-Daten für etwa 4,7 % der weltweiten Todesfälle verantwortlich ist.
- None.
- Early-stage Phase 1/2a trial with no efficacy data yet
- First-in-human trial carries inherent risks and uncertainties
Insights
Clearmind secures critical IRB approval for AUD drug trial at Hadassah, building momentum with prestigious research centers backing their novel psychedelic approach.
Clearmind Medicine has secured a significant regulatory milestone with Institutional Review Board (IRB) approval from Hadassah Medical Center for its Phase 1/2a clinical trial of CMND-100 for Alcohol Use Disorder (AUD). This approval enables patient enrollment at Hadassah, complementing the company's existing network of prestigious research institutions including Yale School of Medicine, Johns Hopkins University, and Tel Aviv Sourasky Medical Center.
The IRB approval follows the company's earlier FDA clearance of its Investigational New Drug (IND) application, demonstrating consistent regulatory progress. CMND-100, a proprietary MEAI-based oral drug candidate, represents an innovative approach in the psychedelic medicine space, targeting a condition with significant global health impact—AUD contributes to 4.7% of worldwide deaths according to WHO data cited in the release.
From a developmental perspective, this Phase 1/2a trial marks a critical early-stage evaluation, assessing safety, tolerability, and pharmacokinetics while gathering preliminary efficacy data on reducing alcohol cravings and consumption. The multinational, multi-center study design enhances statistical power and recruitment potential.
The involvement of multiple prestigious research institutions provides important validation for Clearmind's clinical program and enhances the scientific credibility of their approach. For a clinical-stage biotech company, securing these partnerships represents a significant achievement that typically accelerates enrollment timelines and strengthens future regulatory submissions.
IRB Approval from Hadassah Medical Center Follows FDA IND Clearance and Prior Approvals from Additional Clinical Sites
Vancouver, Canada, Aug. 05, 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 that it has received Institutional Review Board (IRB) approval from Hadassah Medical Center, Jerusalem, Israel, for its ongoing Phase 1/2a clinical trial evaluating CMND-100, a proprietary MEAI-based oral drug candidate, for the treatment of Alcohol Use Disorder (AUD). This approval will enable patient enrollment at Hadassah Medical Center, a leading clinical site in Israel, prior to commencing this first-in-human trial at the site.
The trial includes other first-in-class institutions, such as Yale School of Medicine’s Department of Psychiatry, Johns Hopkins University School of Medicine and Tel Aviv Sourasky Medical Center, Israel. The study at Hadassah-University Medical Center will be led by Prof. Joseph Caraco, Director of Clinical Pharmacology Unit in the Department of Medicine.
IRB approval from Hadassah Medical Center follows Clearmind’s prior regulatory milestones, including U.S. Food and Drug Administration (FDA) clearance of its Investigational New Drug (IND) application and IRB approvals from other clinical sites.
“Securing IRB approval from Hadassah-University Medical Center, a globally respected institution, marks another important step in our journey to address the deep unmet need in Alcohol Use Disorder,” said Dr. Adi Zuloff-Shani, CEO of Clearmind Medicine. “The addition of Hadassah to our growing network of top-tier research centers — including Yale and Johns Hopkins — reflects the strong momentum behind our clinical program and reinforces our commitment to pioneering next-generation psychedelic-based therapies that can truly change lives.”
Clearmind’s clinical trial is a critical step in addressing the global burden of AUD, which accounts for
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 commencing this first-in-human trial at Hadassah Medical Center, its journey to address the deep unmet need in Alcohol Use Disorder, its commitment to pioneering next-generation psychedelic-based therapies that can truly change lives and its anticipation of further progress in patient enrollment and data collection across its clinical sites, with the goal of delivering a breakthrough solution for those affected by AUD 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.
FAQ
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