Clearmind Medicine Launches First U.S. Clinical Site for its FDA-Approved Clinical Trial to Combat Alcoholism
Clearmind Medicine (NASDAQ: CMND) has launched its Phase I/IIa clinical trial for CMND-100, a novel psychedelic-derived treatment for Alcohol Use Disorder (AUD), at Johns Hopkins University School of Medicine. The trial will also be conducted at Yale School of Medicine and IMCA Center in Israel.
The study aims to evaluate the safety, tolerability, and pharmacokinetics of CMND-100, with preliminary efficacy assessments focusing on alcohol craving and consumption reduction. The trial represents the first clinical application of Clearmind's proprietary MEAI-based oral drug platform.
The study will be led by Jennifer Ellis, PhD, and Professor Eric Strain at Johns Hopkins. This initiative addresses a significant global health challenge, as WHO reports approximately 400 million people suffer from alcohol use disorders, with 209 million experiencing alcohol dependence. Alcohol contributes to 2.6 million deaths annually, representing 4.7% of global deaths, with 13% occurring among those aged 20-39.
Clearmind Medicine (NASDAQ: CMND) ha avviato la sperimentazione clinica di Fase I/IIa per CMND-100, un nuovo trattamento derivato da sostanze psichedeliche per il Disturbo da Uso di Alcol (AUD), presso la Johns Hopkins University School of Medicine. La sperimentazione si svolgerà anche presso la Yale School of Medicine e il Centro IMCA in Israele.
Lo studio ha l'obiettivo di valutare la sicurezza, la tollerabilità e la farmacocinetica di CMND-100, con valutazioni preliminari sull'efficacia focalizzate sulla riduzione del desiderio di alcol e del consumo. Questo trial rappresenta la prima applicazione clinica della piattaforma orale proprietaria di Clearmind basata su MEAI.
La ricerca sarà guidata da Jennifer Ellis, PhD, e dal Professor Eric Strain presso Johns Hopkins. Questa iniziativa affronta una sfida sanitaria globale significativa, poiché l'OMS riporta che circa 400 milioni di persone soffrono di disturbi legati all'uso di alcol, con 209 milioni che presentano dipendenza alcolica. L'alcol è responsabile di 2,6 milioni di decessi ogni anno, pari al 4,7% dei decessi globali, di cui il 13% riguarda persone tra i 20 e i 39 anni.
Clearmind Medicine (NASDAQ: CMND) ha iniciado su ensayo clínico de Fase I/IIa para CMND-100, un novedoso tratamiento derivado de psicodélicos para el Trastorno por Consumo de Alcohol (AUD), en la Escuela de Medicina de la Universidad Johns Hopkins. El ensayo también se llevará a cabo en la Escuela de Medicina de Yale y en el Centro IMCA en Israel.
El estudio tiene como objetivo evaluar la seguridad, tolerabilidad y farmacocinética de CMND-100, con evaluaciones preliminares de eficacia centradas en la reducción del deseo y consumo de alcohol. Este ensayo representa la primera aplicación clínica de la plataforma oral propietaria de Clearmind basada en MEAI.
El estudio será dirigido por Jennifer Ellis, PhD, y el Profesor Eric Strain en Johns Hopkins. Esta iniciativa aborda un importante desafío de salud global, ya que la OMS informa que aproximadamente 400 millones de personas sufren trastornos por consumo de alcohol, con 209 millones con dependencia alcohólica. El alcohol contribuye a 2,6 millones de muertes anuales, representando el 4,7% de las muertes globales, con un 13% en personas de 20 a 39 años.
Clearmind Medicine (NASDAQ: CMND)는 Johns Hopkins University School of Medicine에서 알코올 사용 장애(AUD)를 위한 새로운 환각제 유래 치료제 CMND-100의 1/2a상 임상시험을 시작했습니다. 이 임상시험은 Yale School of Medicine과 이스라엘 IMCA 센터에서도 진행될 예정입니다.
본 연구는 CMND-100의 안전성, 내약성 및 약동학을 평가하는 것을 목표로 하며, 초기 효능 평가는 알코올 갈망 및 섭취 감소에 중점을 둡니다. 이 임상시험은 Clearmind의 독자적인 MEAI 기반 경구 약물 플랫폼의 첫 임상 적용입니다.
연구는 Johns Hopkins의 Jennifer Ellis 박사와 Eric Strain 교수가 이끌 예정입니다. 이 이니셔티브는 WHO가 약 4억 명이 알코올 사용 장애를 겪고 있으며, 2억 900만 명이 알코올 의존증을 경험한다고 보고하는 중요한 전 세계 보건 문제를 다룹니다. 알코올은 매년 260만 명의 사망에 기여하며, 전 세계 사망의 4.7%를 차지하고, 그 중 13%는 20~39세 사이에서 발생합니다.
Clearmind Medicine (NASDAQ : CMND) a lancé son essai clinique de phase I/IIa pour CMND-100, un nouveau traitement dérivé de psychédéliques pour le trouble lié à la consommation d’alcool (AUD), à la Johns Hopkins University School of Medicine. L’essai sera également mené à la Yale School of Medicine et au centre IMCA en Israël.
L’étude vise à évaluer la sécurité, la tolérance et la pharmacocinétique de CMND-100, avec des évaluations préliminaires de l’efficacité axées sur la réduction du craving et de la consommation d’alcool. Cet essai représente la première application clinique de la plateforme orale propriétaire de Clearmind basée sur le MEAI.
L’étude sera dirigée par Jennifer Ellis, PhD, et le professeur Eric Strain à Johns Hopkins. Cette initiative répond à un défi sanitaire mondial majeur, l’OMS rapportant qu’environ 400 millions de personnes souffrent de troubles liés à la consommation d’alcool, dont 209 millions présentent une dépendance. L’alcool est responsable de 2,6 millions de décès par an, soit 4,7 % des décès mondiaux, dont 13 % concernent les 20-39 ans.
Clearmind Medicine (NASDAQ: CMND) hat seine Phase I/IIa-Studie für CMND-100, eine neuartige psychedelisch abgeleitete Behandlung für Alkoholgebrauchsstörung (AUD), an der Johns Hopkins University School of Medicine gestartet. Die Studie wird auch an der Yale School of Medicine und dem IMCA-Zentrum in Israel durchgeführt.
Die Studie zielt darauf ab, die Sicherheit, Verträglichkeit und Pharmakokinetik von CMND-100 zu bewerten, wobei vorläufige Wirksamkeitsbeurteilungen auf die Verringerung von Alkoholverlangen und -konsum abzielen. Die Studie stellt die erste klinische Anwendung der firmeneigenen MEAI-basierten oralen Arzneimittelplattform von Clearmind dar.
Die Studie wird von Jennifer Ellis, PhD, und Professor Eric Strain an der Johns Hopkins geleitet. Diese Initiative adressiert eine bedeutende globale Gesundheitsherausforderung, da die WHO berichtet, dass etwa 400 Millionen Menschen an Alkoholgebrauchsstörungen leiden, davon 209 Millionen an Alkoholabhängigkeit. Alkohol verursacht jährlich 2,6 Millionen Todesfälle, was 4,7 % aller Todesfälle weltweit entspricht, davon 13 % bei Personen im Alter von 20 bis 39 Jahren.
- First-ever clinical trial of CMND-100 launched at prestigious institutions (Johns Hopkins, Yale)
- Novel psychedelic-based therapeutic approach targeting major global health issue
- Multiple renowned research centers involved, strengthening trial credibility
- Early-stage trial (Phase I/IIa) with no proven efficacy yet
- Faces competition in large market with established treatments
- Long regulatory pathway ahead before potential commercialization
Insights
Clearmind's initiation of its Phase I/IIa trial for CMND-100 at Johns Hopkins represents a significant clinical milestone that transitions the company from preclinical to human studies. This advancement carries substantial implications given the prestigious nature of the trial sites, which include Johns Hopkins, Yale, and IMCA in Israel - institutional validation that strengthens credibility for this early-stage candidate.
The trial design is particularly noteworthy as it incorporates both standard safety/tolerability measures and preliminary efficacy signals for alcohol craving reduction - an efficient approach that could accelerate development timelines if positive signals emerge. CMND-100's MEAI-based mechanism represents a novel approach to addiction treatment, potentially addressing the substantial limitations of current AUD therapies.
What stands out is the substantial addressable market: 400 million people with alcohol use disorders globally, including 209 million with alcohol dependence. The mortality burden (2.6 million deaths annually) and the recent Surgeon General's advisory linking alcohol to cancer risk create regulatory tailwinds that could accelerate adoption if efficacy is demonstrated.
However, investors should recognize this remains an early-stage clinical program with typical development risks. The trial must establish not only safety but demonstrate preliminary signals that CMND-100's psychedelic-derived approach can effectively modulate the reward mechanisms driving addiction - a complex neurological challenge that has frustrated many previous development efforts.
Vancouver, Canada, April 16, 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, recently announced it has initiated its Phase I/IIa clinical trial at its first U.S. clinical site, the Johns Hopkins University School of Medicine. The first in human clinical trial will investigate the safety, tolerability and full pharmacokinetic profile of Clearmind’s innovative treatment, CMND-100, in Alcohol Use Disorder (AUD) patients. This study is the first clinical application of the Company’s proprietary CMND-100 platform and marks a significant milestone in the Company’s mission to provide innovative solutions for addictions, weight loss and mental health disorders such as depression and anxiety.
The study will be led by the principal investigator, Jennifer Ellis, PhD, Associate Professor of Psychiatry and Behavioral Sciences, JHU School of Medicine and by co-investigator Professor Eric Strain, Director, Behavioral Pharmacology Research Unit, JHU School of Medicine. In addition to Johns Hopkins University School of Medicine, Maryland, USA, the trial will be conducted at Yale School of Medicine’s Department of Psychiatry, Connecticut, USA, and IMCA Center, Ramat-Gan, Israel.
Dr. Adi Zuloff-Shani, CEO of Clearmind, commented: “The initiation of our clinical trial at Johns Hopkins, one of the most respected research institutions in the world, is a significant step in our journey toward FDA approval. The involvement of such esteemed clinical sites in our clinical trial, reflects the growing recognition of CMND-100’s potential as a breakthrough treatment for AUD. With additional clinical sites launching the trial including Yale and IMCA in Israel, we are establishing a strong foundation to evaluate the clinical potential of our psychedelic-based therapeutic platform.”
The Phase I/IIa trial is designed to assess the safety, tolerability, and pharmacokinetics of CMND-100 in individuals diagnosed with AUD. The study will also include preliminary efficacy evaluations, examining the drug’s potential to reduce alcohol cravings and consumption.
CMND-100 is Clearmind’s proprietary MEAI-based oral drug candidate, developed as a potential breakthrough treatment for AUD. Unlike traditional treatment methods, CMND-100 is designed to offer a novel approach by modulating reward mechanisms associated with addictive behavior.
Alcohol Use Disorder remains a major global health challenge, affecting millions of individuals worldwide. The disorder is linked to severe health complications, including liver disease, cardiovascular issues, and mental health disorders. Moreover, US Surgeon General Dr. Vivek Murthy recently issued an advisory warning Americans that alcohol consumption can increase their cancer risk and called for an updated health warning label on alcoholic beverages. Current treatment options remain limited and often ineffective, highlighting the urgent need for innovative therapeutic solutions.
AUD continues to be a significant global health concern, affecting millions worldwide. According to the World Health Organization (WHO), approximately 400 million people aged 15 years and older live with alcohol use disorders, with 209 million experiencing alcohol dependence. The impact of alcohol consumption is profound, contributing to 2.6 million deaths annually, accounting 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 mission to provide innovative solutions for addictions, weight loss and mental health disorders such as depression and anxiety, its journey toward FDA approval and the growing recognition of CMND-100’s potential as a breakthrough treatment for 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
What is the primary objective of Clearmind Medicine's (CMND) Phase I/IIa clinical trial?
Which clinical sites are participating in Clearmind Medicine's (CMND) AUD treatment trial?
What is CMND-100 and how does it differ from traditional AUD treatments?
What is the current global impact of Alcohol Use Disorder according to WHO statistics?
What is the prevalence of AUD among young adults in the United States as of 2023?
