Clearmind Medicine Announces First Participant Ever Dosed with its CMND-100 Treatment in Groundbreaking Clinical Trial for Alcohol Use Disorder
Clearmind Medicine (Nasdaq: CMND) has achieved a significant milestone by dosing the first participant with CMND-100, its proprietary MEAI-based oral drug candidate, in a Phase I/IIa clinical trial for Alcohol Use Disorder (AUD). This marks the first human administration of the company's novel treatment in a clinical setting.
The multinational, multicenter trial is being conducted at prestigious institutions including Yale School of Medicine, Johns Hopkins University, Tel Aviv Sourasky Medical Center, and Hadassah-University Medical Center. The study aims to evaluate the safety, tolerability, and pharmacokinetic profile of CMND-100, while also assessing its preliminary efficacy in reducing alcohol cravings and consumption.
This development follows the company's June 5, 2025 announcement of the first participant enrollment. The trial will include both single- and multiple-dose studies to establish safety and optimal dosing parameters.
Clearmind Medicine (Nasdaq: CMND) ha raggiunto un traguardo importante somministrando il primo partecipante con CMND-100, il suo farmaco orale proprietario a base di MEAI, in uno studio clinico di Fase I/IIa per il Disturbo da Uso di Alcol (AUD). Questo rappresenta la prima somministrazione umana del nuovo trattamento dell'azienda in un contesto clinico.
Lo studio multinazionale e multicentrico viene condotto in istituzioni prestigiose come la Yale School of Medicine, Johns Hopkins University, Tel Aviv Sourasky Medical Center e Hadassah-University Medical Center. L'obiettivo è valutare la sicurezza, la tollerabilità e il profilo farmacocinetico di CMND-100, oltre a esaminare la sua efficacia preliminare nel ridurre il desiderio e il consumo di alcol.
Questo sviluppo segue l'annuncio del 5 giugno 2025 dell'azienda riguardo al primo arruolamento di un partecipante. Lo studio includerà sia dosaggi singoli che multipli per stabilire la sicurezza e i parametri ottimali di dosaggio.
Clearmind Medicine (Nasdaq: CMND) ha alcanzado un hito significativo al administrar la primera dosis a un participante con CMND-100, su candidato a medicamento oral basado en MEAI, en un ensayo clínico de Fase I/IIa para el Trastorno por Uso de Alcohol (AUD). Esto marca la primera administración humana del nuevo tratamiento de la compañía en un entorno clínico.
El ensayo multinacional y multicéntrico se lleva a cabo en instituciones prestigiosas como la Escuela de Medicina de Yale, Universidad Johns Hopkins, Centro Médico Sourasky de Tel Aviv y Centro Médico Hadassah-Universidad. El estudio tiene como objetivo evaluar la seguridad, tolerabilidad y perfil farmacocinético de CMND-100, además de valorar su eficacia preliminar para reducir los antojos y el consumo de alcohol.
Este avance sigue al anuncio de la compañía del 5 de junio de 2025 sobre la inscripción del primer participante. El ensayo incluirá estudios de dosis única y múltiple para establecer la seguridad y los parámetros óptimos de dosificación.
Clearmind Medicine (나스닥: CMND)는 자사의 독자적인 MEAI 기반 경구 약물 후보물질 CMND-100을 알코올 사용 장애(AUD) 대상 1/2a상 임상시험에서 첫 참가자에게 투여하는 중요한 이정표를 달성했습니다. 이는 회사의 새로운 치료제가 임상 환경에서 처음으로 사람에게 투여된 사례입니다.
이 다국적 다기관 임상시험은 예일 의과대학, 존스 홉킨스 대학교, 텔아비브 수라스키 의료센터, 하다사-대학교 의료센터 등 권위 있는 기관에서 진행되고 있습니다. 본 연구는 CMND-100의 안전성, 내약성 및 약동학적 특성을 평가하고, 알코올 갈망 및 섭취 감소에 대한 예비 효능도 확인하는 것을 목표로 합니다.
이번 진행은 2025년 6월 5일 회사가 첫 참가자 등록을 발표한 데 따른 것입니다. 임상시험은 단회 및 다회 투여 연구를 포함하여 안전성과 최적 투여 용량을 확립할 예정입니다.
Clearmind Medicine (Nasdaq : CMND) a franchi une étape importante en administrant la première dose de CMND-100, son candidat médicament oral propriétaire à base de MEAI, à un participant dans un essai clinique de phase I/IIa pour le trouble lié à la consommation d'alcool (AUD). Il s'agit de la première administration humaine du nouveau traitement de la société dans un cadre clinique.
L'essai multinational et multicentrique est réalisé dans des institutions prestigieuses telles que la Yale School of Medicine, l'Université Johns Hopkins, le Centre médical Sourasky de Tel Aviv et le Centre médical universitaire Hadassah. L'étude vise à évaluer la sécurité, la tolérance et le profil pharmacocinétique de CMND-100, tout en évaluant son efficacité préliminaire pour réduire les envies et la consommation d'alcool.
Cette avancée fait suite à l'annonce de la société du 5 juin 2025 concernant l'inscription du premier participant. L'essai comprendra des études à dose unique et à doses multiples afin d'établir la sécurité et les paramètres optimaux de dosage.
Clearmind Medicine (Nasdaq: CMND) hat einen bedeutenden Meilenstein erreicht, indem es den ersten Teilnehmer mit CMND-100, seinem proprietären MEAI-basierten oralen Arzneimittelkandidaten, in einer Phase I/IIa-Studie zur Behandlung der Alkoholkonsumstörung (AUD) dosiert hat. Dies markiert die erste Anwendung der neuartigen Behandlung des Unternehmens am Menschen in einem klinischen Umfeld.
Die multinationale, multizentrische Studie wird an renommierten Einrichtungen wie der Yale School of Medicine, Johns Hopkins University, Tel Aviv Sourasky Medical Center und Hadassah-Universitätsklinikum durchgeführt. Ziel der Studie ist es, die Sicherheit, Verträglichkeit und das pharmakokinetische Profil von CMND-100 zu bewerten sowie die vorläufige Wirksamkeit bei der Verringerung von Alkoholverlangen und -konsum zu prüfen.
Diese Entwicklung folgt auf die Bekanntgabe des Unternehmens vom 5. Juni 2025 über die Einschreibung des ersten Teilnehmers. Die Studie umfasst sowohl Einzel- als auch Mehrfachdosierungsstudien zur Festlegung der Sicherheit und optimalen Dosierungsparameter.
- First-ever human dosing of CMND-100 achieved in clinical trial setting
- Trial being conducted at multiple prestigious medical institutions
- Study designed to evaluate both safety and preliminary efficacy
- Potential to address large, underserved market of AUD patients
- Early-stage Phase I/IIa trial with no efficacy data yet available
- Safety and optimal dosing still need to be established
Insights
Clearmind reaches critical milestone with first human dosing of CMND-100 for alcohol use disorder, marking significant clinical advancement.
Clearmind Medicine has achieved a significant clinical milestone with the first-ever human dosing of CMND-100, its proprietary MEAI-based oral drug candidate for Alcohol Use Disorder (AUD). This development represents a crucial inflection point in the company's clinical program, as first-in-human dosing provides initial safety and tolerability data essential for advancing the therapeutic candidate.
The Phase I/IIa trial is particularly notable for its comprehensive design and prestigious research partners, including Yale School of Medicine, Johns Hopkins University, Tel Aviv Sourasky Medical Center, and Hadassah-University Medical Center. This multinational, multicenter approach enhances the study's credibility and potential for robust data generation. The trial's dual focus on safety/pharmacokinetics and preliminary efficacy signals represents an efficient clinical development strategy.
AUD represents a substantial market opportunity with limited effective treatment options. The condition affects millions worldwide, with current therapies showing modest efficacy and significant limitations. CMND-100, described as a "neuroplastogen compound," suggests a novel mechanism of action that could potentially address underlying neurological factors in addiction rather than simply managing symptoms.
While this milestone signifies progress, investors should recognize the early stage of development. The trial will evaluate both single and multiple doses, suggesting a thorough dose-finding exercise that will inform future efficacy studies. The inclusion of preliminary efficacy measures around alcohol consumption and cravings could provide early validation of the concept, potentially accelerating the development timeline if positive signals emerge.
Vancouver, Canada, June 30, 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 a historic milestone: the first participant has been dosed with CMND-100, its proprietary MEAI-based oral drug candidate, in its Phase I/IIa clinical trial for the treatment of Alcohol Use Disorder (AUD). This marks the first time a patient has received Clearmind’s innovative treatment in a clinical setting, a critical step toward the development of a potential new therapy for millions affected by AUD worldwide.
The dosing follows the Company’s announcement on June 5, 2025, of the enrollment of the first participant in the trial, which is being conducted at leading clinical sites, 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 Hadassah-University Medical Center in Jerusalem. The Phase I/IIa trial is designed to evaluate the safety, tolerability, and pharmacokinetic profile of CMND-100, while also assessing its preliminary efficacy in reducing alcohol cravings and consumption in patients with AUD.
“Dosing the first participant with CMND-100 in our study marks a landmark achievement towards the development of a new solution and offering new hope for the massive, underserved community suffering from alcoholism,” said Dr. Adi Zuloff-Shani, Ph. D, CEO of Clearmind Medicine. “This exciting event marks the first time our proprietary neuroplastogen compound has been given to humans under controlled clinical trial settings, bringing us closer to potentially delivering a revolutionary treatment for the millions of individuals and families suffering from AUD.”
The Phase I/IIa clinical trial is a multinational, multicenter, single- and multiple-dose study that aims to establish the safety and optimal dosing of CMND-100. The trial will also explore early signals of efficacy, including reductions in alcohol consumption and cravings, which could pave the way for further development of this groundbreaking therapy.
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 CMND-100 being a potential new therapy for millions affected by AUD worldwide and the Company potentially delivering a revolutionary treatment for the millions of individuals and families suffering from AUD. 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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