Clearmind Expands its Clinical Trial for Alcohol Use: New Site Activated and Additional Participant Enrolled
Clearmind Medicine (Nasdaq: CMND) has expanded its Phase I/IIa clinical trial for CMND-100, its MEAI-based oral treatment for Alcohol Use Disorder (AUD). The company has activated a new clinical site at Johns Hopkins University School of Medicine and enrolled its first participant there.
The trial aims to evaluate safety, tolerability, and pharmacokinetic profile of CMND-100, while also assessing preliminary efficacy in reducing alcohol cravings and consumption. This expansion follows the recent enrollment of the first participant at Yale School of Medicine, demonstrating momentum in the multinational, multicenter study.
Clearmind Medicine (Nasdaq: CMND) ha ampliato il suo studio clinico di Fase I/IIa per CMND-100, il trattamento orale a base di MEAI per il Disturbo da Uso di Alcol (AUD). L'azienda ha attivato un nuovo centro clinico presso la Johns Hopkins University School of Medicine e ha arruolato il primo partecipante in questa sede.
Lo studio mira a valutare la sicurezza, la tollerabilità e il profilo farmacocinetico di CMND-100, oltre a esaminare l'efficacia preliminare nella riduzione del desiderio e del consumo di alcol. Questa espansione segue l'arruolamento recente del primo partecipante presso la Yale School of Medicine, dimostrando slancio nello studio multinazionale e multicentrico.
Clearmind Medicine (Nasdaq: CMND) ha ampliado su ensayo clínico de Fase I/IIa para CMND-100, su tratamiento oral basado en MEAI para el Trastorno por Uso de Alcohol (AUD). La compañía ha activado un nuevo sitio clínico en la Johns Hopkins University School of Medicine y ha inscrito a su primer participante allí.
El ensayo tiene como objetivo evaluar la seguridad, tolerabilidad y perfil farmacocinético de CMND-100, además de valorar la eficacia preliminar para reducir los antojos y el consumo de alcohol. Esta expansión sigue a la reciente inscripción del primer participante en la Yale School of Medicine, demostrando impulso en este estudio multinacional y multicéntrico.
Clearmind Medicine (나스닥: CMND)는 알코올 사용 장애(AUD)를 위한 MEAI 기반 경구 치료제 CMND-100의 1/2a상 임상시험을 확대했습니다. 회사는 존스 홉킨스 대학교 의과대학에 새로운 임상 시험 기관을 개설하고 첫 참가자를 등록했습니다.
이번 임상시험은 CMND-100의 안전성, 내약성 및 약동학적 특성을 평가하는 동시에 알코올 갈망과 섭취 감소에 대한 초기 효능도 검토하는 것을 목표로 합니다. 이번 확장은 예일 의과대학에서 첫 참가자 등록이 최근 이루어진 데 이어 다국가 다기관 연구에 탄력을 더하고 있습니다.
Clearmind Medicine (Nasdaq : CMND) a étendu son essai clinique de phase I/IIa pour CMND-100, son traitement oral à base de MEAI pour le trouble lié à l’usage d’alcool (AUD). La société a activé un nouveau site clinique à la Johns Hopkins University School of Medicine et y a recruté son premier participant.
L’essai vise à évaluer la sécurité, la tolérabilité et le profil pharmacocinétique de CMND-100, tout en évaluant également l’efficacité préliminaire pour réduire les envies et la consommation d’alcool. Cette expansion fait suite à l’inscription récente du premier participant à la Yale School of Medicine, témoignant de l’élan pris par cette étude multinationale et multicentrique.
Clearmind Medicine (Nasdaq: CMND) hat seine Phase-I/IIa-Studie für CMND-100, seine MEAI-basierte orale Behandlung der Alkoholkonsumstörung (AUD), erweitert. Das Unternehmen hat eine neue Studienstätte an der Johns Hopkins University School of Medicine aktiviert und dort den ersten Teilnehmer eingeschlossen.
Die Studie zielt darauf ab, die Sicherheit, Verträglichkeit und das pharmakokinetische Profil von CMND-100 zu bewerten und gleichzeitig die vorläufige Wirksamkeit bei der Reduzierung von Alkoholverlangen und -konsum zu untersuchen. Diese Erweiterung folgt auf die kürzliche Einschreibung des ersten Teilnehmers an der Yale School of Medicine und zeigt den Fortschritt der multinationalen, multizentrischen Studie.
- Expansion of clinical trial network with addition of prestigious Johns Hopkins site
- Successful enrollment of new participant at Johns Hopkins, following recent Yale enrollment
- Growing scientific community interest in CMND-100 treatment approach
- Early-stage trial (Phase I/IIa) with no efficacy data yet available
- Long pathway ahead before potential commercialization
Insights
Clearmind's AUD trial expansion shows trial execution progress but remains in early stages with no efficacy data yet.
Clearmind Medicine has expanded its Phase I/IIa clinical trial for CMND-100, adding a site at Johns Hopkins alongside the existing Yale School of Medicine location. The trial is testing this MEAI-based compound as a potential treatment for Alcohol Use Disorder (AUD), which represents a substantial market with limited effective treatment options.
The trial is designed with dual objectives: primary endpoints focusing on safety, tolerability, and pharmacokinetics, with secondary exploratory endpoints looking at potential efficacy signals through reduction in alcohol consumption and cravings. This multi-center, multinational approach strengthens the trial's potential validity while potentially accelerating recruitment.
From a development perspective, this announcement represents operational execution but contains no actual clinical data. The company remains in early clinical stages with this asset, as Phase I/IIa trials primarily establish safety parameters rather than definitive efficacy. Adding Johns Hopkins - a prestigious research institution - may enhance the trial's credibility and help with patient recruitment.
The psychedelic-derived therapeutics space has seen growing interest, with compounds being repurposed for various psychiatric and addiction disorders. However, investors should note that CMND-100 faces a long development timeline before potential commercialization, with success in these early-stage trials far from guaranteeing ultimate FDA approval. The company will need to demonstrate not just safety but meaningful efficacy in larger trials before CMND-100 could become a viable commercial product for AUD treatment.
Vancouver, Canada, July 15, 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 expansion of its Phase I/IIa clinical trial for CMND-100, its proprietary MEAI-based oral treatment candidate for Alcohol Use Disorder (AUD), with the activation of additional site at Johns Hopkins University School of Medicine and the enrollment of the first participant at this clinical site.
The trial is designed to evaluate the safety, tolerability, and pharmacokinetic profile of CMND-100, with preliminary efficacy indicators assessing its potential to reduce alcohol cravings and consumption.
This expansion comes shortly after the Company announced the enrollment of its first participant at the Yale School of Medicine, reinforcing the positive momentum in Clearmind’s clinical development program.
The continuation of enrollment further expands Clearmind’s international clinical network and strengthens the growing interest in CMND-100 as a potentially groundbreaking treatment for 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.
“Each new clinical site we activate and each new participant we enroll brings us one step closer to validating CMND-100’s potential to redefine the treatment landscape for AUD,” said Dr. Adi Zuloff-Shani, CEO of Clearmind. “This expansion reflects both the scientific community’s interest in our approach and our commitment to accelerating progress for patients in need of better solutions.”
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 the growing interest in CMND-100 as a potentially groundbreaking treatment for Alcohol Use Disorder, how the continued enrollment further expands Clearmind’s international clinical network, CMND-100’s potential to redefine the treatment landscape for Alcohol Use Disorder and its commitment to accelerating progress for patients in need of better solutions. 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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