Clearmind Medicine Announces IRB Approval for Phase 1/2a Clinical Trial for Alcohol Use Disorder at Tel Aviv Sourasky Medical Center
Clearmind Medicine (NASDAQ: CMND) has received Institutional Review Board (IRB) approval from Tel Aviv Sourasky Medical Center (TASMC) for its ongoing Phase 1/2a clinical trial of CMND-100, a MEAI-based oral drug candidate for Alcohol Use Disorder (AUD).
The trial, which recently began dosing its first participant, will be conducted at several prestigious institutions including Yale School of Medicine, Johns Hopkins University, and Hadassah-University Medical Center. At TASMC, the study will be led by Dr. David Zeltser, Director of Emergency Medicine Department.
The multinational, multi-center study aims to evaluate CMND-100's safety, tolerability, and pharmacokinetic profile, while assessing its preliminary efficacy in reducing alcohol cravings and consumption in AUD patients. This development addresses a significant global health issue, as AUD accounts for 4.7% of worldwide deaths according to WHO.
Clearmind Medicine (NASDAQ: CMND) ha ottenuto l'approvazione del Comitato Etico (IRB) del Tel Aviv Sourasky Medical Center (TASMC) per il suo trial clinico in corso di fase 1/2a su CMND-100, un candidato farmaco orale a base di MEAI per il Disturbo da Uso di Alcol (AUD).
Lo studio, che ha recentemente iniziato la somministrazione al primo partecipante, sar脿 condotto in diversi istituti prestigiosi tra cui la Yale School of Medicine, la Johns Hopkins University e l'Hadassah-University Medical Center. Al TASMC, la ricerca sar脿 guidata dal Dr. David Zeltser, Direttore del Dipartimento di Medicina d'Emergenza.
Lo studio multinazionale e multicentrico mira a valutare la sicurezza, la tollerabilit脿 e il profilo farmacocinetico di CMND-100, oltre a valutarne l'efficacia preliminare nel ridurre la voglia di alcol e il consumo nei pazienti con AUD. Questo sviluppo affronta un importante problema di salute globale, dato che l'AUD 猫 responsabile del 4,7% dei decessi nel mondo secondo l'OMS.
Clearmind Medicine (NASDAQ: CMND) ha recibido la aprobaci贸n del Comit茅 de Revisi贸n Institucional (IRB) del Tel Aviv Sourasky Medical Center (TASMC) para su ensayo cl铆nico en curso de fase 1/2a de CMND-100, un candidato a medicamento oral basado en MEAI para el Trastorno por Uso de Alcohol (AUD).
El ensayo, que recientemente comenz贸 a administrar dosis al primer participante, se llevar谩 a cabo en varias instituciones prestigiosas, incluyendo la Yale School of Medicine, Johns Hopkins University y el Hadassah-University Medical Center. En TASMC, el estudio estar谩 dirigido por el Dr. David Zeltser, Director del Departamento de Medicina de Emergencia.
El estudio multinacional y multic茅ntrico tiene como objetivo evaluar la seguridad, tolerabilidad y perfil farmacocin茅tico de CMND-100, adem谩s de valorar su eficacia preliminar para reducir los antojos y el consumo de alcohol en pacientes con AUD. Este desarrollo aborda un problema de salud global significativo, ya que el AUD representa el 4,7% de las muertes a nivel mundial seg煤n la OMS.
Clearmind Medicine (NASDAQ: CMND)電� Tel Aviv Sourasky Medical Center(TASMC)搿滊秬韯� MEAI 旮半皹 瓴疥惮 鞎诫 頉勲炒鞚� CMND-100鞐� 雽�頃� 1/2a靸� 鞛勳儊鞁滍棙 歆勴枆鞚� 鞙勴暅 旮瓣磤鞁偓鞙勳洂須�(IRB) 鞀轨澑鞚� 氚涭晿鞀惦媹雼�. 鞚� 鞎诫鞚� 鞎岇綌鞓� 靷毄 鞛レ暊(AUD)毳� 雽�靸侅溂搿� 頃╇媹雼�.
斓滉芳 觳� 彀戈皜鞛� 韴暯鞚� 鞁滌瀾頃� 鞚� 鞛勳儊鞁滍棙鞚� 鞓堨澕 鞚橁臣雽�頃�, 臁挫姢 頇夗偍鞀� 雽�頃欔祼, 頃橂嫟靷�-雽�頃欔祼 鞚橂靹柬劙 霌� 鞐煬 鞝�氇呿暅 旮瓣磤鞐愳劀 歆勴枆霅╇媹雼�. TASMC鞐愳劀電� 鞚戧笁鞚橅暀瓿检灔鞚� David Zeltser 氚曥偓臧� 鞐瓣惮毳� 鞚措亴 鞓堨爼鞛呺媹雼�.
雼り淡鞝� 雼り赴甏� 鞐瓣惮鞚� 鞚措矆 鞁滍棙鞚� CMND-100鞚� 鞎堨爠靹�, 雮挫暯靹� 氚� 鞎诫彊頃欖爜 韸轨劚鞚� 韽夑皜頃橁碃, AUD 頇橃瀽鞚� 鞎岇綌鞓� 臧堧瓿� 靻岆箘 臧愳唽鞐� 雽�頃� 鞓堧箘 須姤鞚� 頇曥澑頃橂姅 瓴冹潉 氇╉憸搿� 頃╇媹雼�. WHO鞐� 霐半ゴ氅� AUD電� 鞝� 靹戈硠 靷鞚� 4.7%毳� 彀頃橂姅 欷戩殧頃� 旮�搿滊矊 瓯搓皶 氍胳牅鞛呺媹雼�.
Clearmind Medicine (NASDAQ : CMND) a re莽u l'approbation du comit茅 d'茅thique (IRB) du Tel Aviv Sourasky Medical Center (TASMC) pour son essai clinique en cours de phase 1/2a portant sur CMND-100, un candidat m茅dicament oral 脿 base de MEAI destin茅 au trouble li茅 脿 l'usage d'alcool (AUD).
L'essai, qui a r茅cemment commenc茅 脿 administrer la premi猫re dose 脿 un participant, se d茅roulera dans plusieurs institutions prestigieuses, notamment la Yale School of Medicine, l'Universit茅 Johns Hopkins et le Hadassah-University Medical Center. Au TASMC, l'茅tude sera dirig茅e par le Dr David Zeltser, directeur du d茅partement de m茅decine d'urgence.
Cette 茅tude multinationale et multicentrique vise 脿 茅valuer la s没ret茅, la tol茅rabilit茅 et le profil pharmacocin茅tique de CMND-100, tout en examinant son efficacit茅 pr茅liminaire pour r茅duire les envies et la consommation d'alcool chez les patients atteints d'AUD. Ce d茅veloppement r茅pond 脿 un probl猫me de sant茅 mondiale majeur, puisque l'AUD repr茅sente 4,7 % des d茅c猫s dans le monde selon l'OMS.
Clearmind Medicine (NASDAQ: CMND) hat die Genehmigung der Ethikkommission (IRB) des Tel Aviv Sourasky Medical Center (TASMC) f眉r seine laufende Phase-1/2a-Studie zu CMND-100 erhalten, einem oralen Medikamentenkandidaten auf MEAI-Basis zur Behandlung der Alkoholgebrauchsst枚rung (AUD).
Die Studie, die k眉rzlich mit der Dosierung des ersten Teilnehmers begann, wird an mehreren renommierten Einrichtungen durchgef眉hrt, darunter die Yale School of Medicine, Johns Hopkins University und das Hadassah-University Medical Center. Am TASMC wird die Studie von Dr. David Zeltser, Direktor der Notfallmedizin, geleitet.
Die multinationale, multizentrische Studie zielt darauf ab, die Sicherheit, Vertr盲glichkeit und das pharmakokinetische Profil von CMND-100 zu bewerten und gleichzeitig die vorl盲ufige Wirksamkeit bei der Reduzierung von Alkoholverlangen und -konsum bei AUD-Patienten zu untersuchen. Diese Entwicklung adressiert ein bedeutendes globales Gesundheitsproblem, da AUD laut WHO f眉r 4,7 % der weltweiten Todesf盲lle verantwortlich ist.
- Received IRB approval from prestigious Tel Aviv Sourasky Medical Center
- Trial includes leading institutions like Yale and Johns Hopkins
- Successfully dosed first participant in the Phase 1/2a trial
- Previously received FDA clearance for IND application
- Early-stage clinical trial with no efficacy data yet
- Faces competition in large AUD treatment market
Insights
Clearmind's IRB approval for AUD drug trial at prestigious TASMC advances their clinical program, though still early-stage with long development path ahead.
Clearmind Medicine has secured a significant Institutional Review Board (IRB) approval from Tel Aviv Sourasky Medical Center (TASMC) for its ongoing Phase 1/2a clinical trial of CMND-100, a proprietary MEAI-based drug candidate for Alcohol Use Disorder (AUD). This regulatory milestone enables patient enrollment at TASMC, adding another prestigious institution to their clinical sites alongside Yale, Johns Hopkins, and Hadassah Medical Center.
The trial has already reached an important milestone with the dosing of the first participant, marking the transition from preclinical to clinical development. This early-stage trial aims to establish safety, tolerability, and pharmacokinetics while collecting preliminary efficacy data on reducing alcohol cravings and consumption.
While this progress is encouraging, investors should understand that CMND-100 remains in early-stage clinical development. The Phase 1/2a designation indicates this is primarily a safety-focused study with exploratory efficacy endpoints. The path from current testing to potential approval remains lengthy and uncertain, likely requiring larger Phase 2b and Phase 3 trials if initial results prove promising.
The company is targeting a significant unmet medical need, as AUD contributes to 4.7% of deaths worldwide according to WHO data cited in the release. Current pharmacological options for AUD are limited in efficacy, creating potential market opportunity if CMND-100's novel psychedelic-derived mechanism proves effective and safe. However, clinical success in early trials is no guarantee of ultimate regulatory approval or commercial success.
Vancouver, Canada, July 03, 2025 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (鈥淐learmind鈥� 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 Tel Aviv Sourasky Medical Center (TASMC) in Tel Aviv, 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 TASMC, 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鈥檚 Department of Psychiatry, Johns Hopkins University School of Medicine and Hadassah-University Medical Center in Jerusalem, Israel. The study at TASMC will be led by Dr. David Zeltser, Director of the Emergency Medicine Department and Deputy Director R&D and Innovation.
Clearmind recently announced the dosing of the first participant in the trial, marking a historic step toward developing a novel therapy for the millions affected by AUD worldwide.
IRB approval from TASMC follows Clearmind鈥檚 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.
鈥淲e are pleased to receive IRB approval from Tel Aviv Sourasky Medical Center, a renowned institution, for our Phase 1/2a clinical trial,鈥� said Dr. Adi Zuloff-Shani, CEO of Clearmind Medicine. 鈥淭his milestone brings us closer to potentially offering a transformative treatment for individuals struggling with AUD, a condition that devastates millions of lives. With TASMC鈥檚 participation, alongside leading centers like Yale and Johns Hopkins, we believe that we are well-positioned to advance our mission of developing safe, effective, and innovative psychedelic-derived therapies.鈥�
Clearmind鈥檚 clinical trial is a critical step in addressing the global burden of AUD, which accounts for
础产辞耻迟听颁濒别补谤尘颈苍诲听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鈥檚 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 鈥淐WY0.鈥�
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Forward-Looking Statements:
This press release contains 鈥渇orward-looking statements鈥� within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as 鈥渆xpects,鈥� 鈥渁nticipates,鈥� 鈥渋ntends,鈥� 鈥減lans,鈥� 鈥渂elieves,鈥� 鈥渟eeks,鈥� 鈥渆stimates鈥� 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 potentially offering a transformative treatment for individuals struggling with Alcohol Use Disorder, its belief that it is well-positioned to advance its mission of developing safe, effective, and innovative psychedelic-derived therapies 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鈥檚 current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith.聽However, there can be no assurance that management鈥檚 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聽made to the Company鈥檚 reports filed from time to time with the Securities and Exchange Commission (鈥淪EC鈥�), including, but not limited to, the risks detailed in the Company鈥檚 annual report on Form 20-F for the fiscal year ended October 31,聽2024聽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) Phase 1/2a clinical trial?
Which institutions are participating in Clearmind Medicine's (CMND) clinical trial?
What regulatory approvals has Clearmind Medicine (CMND) received for its AUD treatment?
How significant is the market need for Clearmind Medicine's (CMND) AUD treatment?
What is CMND-100 and how is it being developed?
