Clearmind Medicine Announces First U.S. Clinical Site Initiation for CMND-100 Clinical Trial in Patients with Alcohol Use Disorder
Clearmind Medicine (NASDAQ: CMND) has initiated 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 in AUD patients, including preliminary efficacy assessments for reducing alcohol cravings and consumption. CMND-100 is a proprietary MEAI-based oral drug candidate designed to modulate reward mechanisms associated with addictive behavior.
The trial's significance is underscored by global AUD statistics: 400 million people aged 15 and older live with alcohol use disorders, with 209 million experiencing alcohol dependence. Alcohol contributes to 2.6 million deaths annually (4.7% of global deaths), with 13% occurring among ages 20-39. In the US, 15.1% of adults aged 18-25 met past-year AUD criteria according to the 2023 NSDUH.
Clearmind Medicine (NASDAQ: CMND) ha avviato il suo studio clinico di Fase I/IIa per CMND-100, un nuovo trattamento derivato da psichedelici per il Disturbo da Uso di Alcol (AUD), presso la Johns Hopkins University School of Medicine. Lo studio sarà condotto anche presso la Yale School of Medicine e l'IMCA Center in Israele.
Lo scopo della ricerca è valutare la sicurezza, la tollerabilità e la farmacocinetica di CMND-100 nei pazienti con AUD, inclusi i primi valutazioni di efficacia per ridurre i desideri e il consumo di alcol. CMND-100 è un candidato farmaco orale a base di MEAI progettato per modulare i meccanismi di ricompensa associati ai comportamenti di dipendenza.
La rilevanza dello studio è sottolineata dalle statistiche globali sull'AUD: 400 milioni di persone di età pari o superiore a 15 anni vivono con disturbi da uso di alcol, di cui 209 milioni sperimentano dipendenza da alcol. L'alcol contribuisce a 2,6 milioni di decessi annuali (4,7% dei decessi globali), con il 13% che si verifica tra le persone di età compresa tra 20 e 39 anni. Negli Stati Uniti, il 15,1% degli adulti di età compresa tra 18 e 25 anni ha soddisfatto i criteri per l'AUD nell'ultimo anno secondo il NSDUH 2023.
Clearmind Medicine (NASDAQ: CMND) ha iniciado su ensayo clínico de Fase I/IIa para CMND-100, un nuevo 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 en pacientes con AUD, incluidas las evaluaciones preliminares de eficacia para reducir los antojos y el consumo de alcohol. CMND-100 es un candidato a medicamento oral basado en MEAI diseñado para modular los mecanismos de recompensa asociados con el comportamiento adictivo.
La importancia del ensayo se subraya con las estadísticas globales de AUD: 400 millones de personas de 15 años o más viven con trastornos por consumo de alcohol, de los cuales 209 millones experimentan dependencia del alcohol. El alcohol contribuye a 2,6 millones de muertes anuales (4,7% de las muertes globales), con el 13% ocurriendo entre las edades de 20 a 39 años. En EE. UU., el 15,1% de los adultos de 18 a 25 años cumplió con los criterios de AUD en el último año según el NSDUH 2023.
클리어마인드 메디슨 (NASDAQ: CMND)는 존스 홉킨스 의과대학에서 알코올 사용 장애(AUD)를 위한 새로운 환각제 유래 치료제인 CMND-100의 1/2상 임상 시험을 시작했습니다. 이 시험은 예일 의과대학과 이스라엘 IMCA 센터에서도 진행됩니다.
이 연구의 목적은 AUD 환자에서 CMND-100의 안전성, 내약성 및 약물 동태학을 평가하고, 알코올에 대한 욕구와 소비를 줄이기 위한 초기 효능 평가를 포함하는 것입니다. CMND-100은 중독 행동과 관련된 보상 메커니즘을 조절하도록 설계된 MEAI 기반의 경구 약물 후보입니다.
이 시험의 중요성은 전 세계 AUD 통계에 의해 강조됩니다: 4억 명의 사람들이 15세 이상으로 알코올 사용 장애를 겪고 있으며, 그 중 2억 9천만 명이 알코올 의존증을 경험하고 있습니다. 알코올은 매년 260만 명의 사망에 기여하며(전 세계 사망의 4.7%), 13%는 20-39세 사이에서 발생합니다. 미국에서는 18-25세 성인의 15.1%가 2023 NSDUH에 따르면 지난 1년 동안 AUD 기준을 충족했습니다.
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 de l'Usage de l'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 sûreté, la tolérance et la pharmacocinétique de CMND-100 chez les patients atteints d'AUD, y compris des évaluations préliminaires de l'efficacité pour réduire les envies et la consommation d'alcool. CMND-100 est un candidat médicament oral basé sur MEAI conçu pour moduler les mécanismes de récompense associés à un comportement addictif.
L'importance de l'essai est soulignée par les statistiques mondiales sur l'AUD : 400 millions de personnes âgées de 15 ans et plus vivent avec des troubles liés à l'usage de l'alcool, dont 209 millions souffrent de dépendance à l'alcool. L'alcool contribue à 2,6 millions de décès chaque année (4,7 % des décès mondiaux), dont 13 % surviennent chez les 20-39 ans. Aux États-Unis, 15,1 % des adultes âgés de 18 à 25 ans ont satisfait aux critères de l'AUD au cours de l'année précédente selon le NSDUH 2023.
Clearmind Medicine (NASDAQ: CMND) hat seine Phase I/IIa-Studie für CMND-100, eine neuartige psychedelisch abgeleitete Behandlung für Alkoholgebrauchsstörungen (AUD), an der Johns Hopkins University School of Medicine gestartet. Die Studie wird auch an der Yale School of Medicine und im IMCA Center in Israel durchgeführt.
Das Ziel der Studie ist es, die Sicherheit, Verträglichkeit und Pharmakokinetik von CMND-100 bei AUD-Patienten zu bewerten, einschließlich erster Wirksamkeitsbewertungen zur Reduzierung von Alkoholverlangen und -konsum. CMND-100 ist ein proprietärer, MEAI-basierter oraler Arzneimittelkandidat, der entwickelt wurde, um Belohnungsmechanismen zu modulieren, die mit süchtig machendem Verhalten verbunden sind.
Die Bedeutung der Studie wird durch die globalen AUD-Statistiken unterstrichen: 400 Millionen Menschen im Alter von 15 Jahren und älter leben mit Alkoholgebrauchsstörungen, wobei 209 Millionen an Alkoholabhängigkeit leiden. Alkohol trägt jährlich zu 2,6 Millionen Todesfällen bei (4,7 % der weltweiten Todesfälle), wobei 13 % zwischen 20 und 39 Jahren auftreten. In den USA erfüllten 15,1 % der Erwachsenen im Alter von 18 bis 25 Jahren laut der NSDUH 2023 die Kriterien für AUD im vergangenen Jahr.
- Initiated Phase I/IIa clinical trial at prestigious institutions (Johns Hopkins, Yale)
- Multiple clinical sites across US and Israel expanding trial reach
- Addresses large market opportunity with 400M people affected by AUD globally
- Novel approach to treating AUD through psychedelic-derived therapeutics
- Early-stage clinical trial with no proven efficacy yet
- Faces competition in crowded AUD treatment market
- Long regulatory pathway ahead before potential FDA approval
Insights
Clearmind's initiation of a Phase I/IIa clinical trial for CMND-100 at Johns Hopkins represents a significant milestone in their psychedelic-derived therapeutic development program. This first-in-human study for Alcohol Use Disorder (AUD) demonstrates critical advancement in their clinical pathway.
The company has strategically established a multi-center trial across prestigious institutions - Johns Hopkins, Yale, and IMCA in Israel. This approach not only accelerates enrollment potential but enhances credibility through association with world-class research centers. The involvement of respected researchers like Dr. Jennifer Ellis and Professor Eric Strain further strengthens the scientific rigor of this program.
The trial design is comprehensive, evaluating not just safety and pharmacokinetics typical of early-phase studies, but also incorporating preliminary efficacy measures on alcohol cravings and consumption. This hybrid Phase I/IIa approach potentially accelerates their development timeline.
For a clinical-stage biotech with
This milestone demonstrates Clearmind has successfully navigated the complex regulatory requirements to advance from preclinical to clinical development, a critical hurdle where many biotech candidates fail. The focus on AUD also aligns with heightened public health awareness, as evidenced by the US Surgeon General's recent advisory on alcohol's cancer risks.
Vancouver, Canada, April 10, 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, announced today that 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 purpose of Clearmind Medicine's (CMND) Phase I/IIa clinical trial for CMND-100?
Where will Clearmind Medicine's CMND-100 clinical trial be conducted?
How many people globally are affected by Alcohol Use Disorder according to CMND's research?
What makes CMND-100 different from traditional AUD treatments?
