Clearmind Medicine Announces Initiation of First in Human Clinical Trial with CMND-100 in Alcohol Use Disorder Patients
Clearmind Medicine (Nasdaq: CMND) has initiated its Phase I/IIa clinical trial for CMND-100, marking its transition to a clinical-stage pharmaceutical company. The trial will evaluate the safety, tolerability, and pharmacokinetics of CMND-100 in Alcohol Use Disorder (AUD) patients.
The study will be conducted at three prestigious institutions: IMCA in Israel, led by Prof. Mark Weiser, Yale School of Medicine's Department of Psychiatry, and Johns Hopkins University School of Medicine. The trial will also assess preliminary efficacy in reducing alcohol cravings and consumption.
CMND-100 is the company's proprietary MEAI-based oral drug candidate, designed to offer a novel approach by modulating reward mechanisms associated with addictive behavior. This represents a potential breakthrough in addressing the global AUD crisis, which affects approximately 400 million people worldwide and contributes to 2.6 million deaths annually according to WHO data.
Clearmind Medicine (Nasdaq: CMND) ha avviato il suo trial clinico di fase I/IIa per CMND-100, segnando la sua transizione a un'azienda farmaceutica in fase clinica. Lo studio valuterà la sicurezza, la tollerabilità e la farmacocinetica di CMND-100 in pazienti con Disturbo da Uso di Alcol (AUD).
La ricerca sarà condotta presso tre prestigiose istituzioni: IMCA in Israele, guidata dal Prof. Mark Weiser, il Dipartimento di Psichiatria della Yale School of Medicine e la Johns Hopkins University School of Medicine. Il trial valuterà anche l'efficacia preliminare nella riduzione dei desideri e del consumo di alcol.
CMND-100 è il candidato farmaco orale proprietario dell'azienda, basato su MEAI, progettato per offrire un approccio innovativo modulando i meccanismi di ricompensa associati ai comportamenti di dipendenza. Questo rappresenta una potenziale svolta nell'affrontare la crisi globale dell'AUD, che colpisce circa 400 milioni di persone in tutto il mondo e contribuisce a 2,6 milioni di decessi annuali secondo i dati dell'OMS.
Clearmind Medicine (Nasdaq: CMND) ha iniciado su ensayo clínico de fase I/IIa para CMND-100, marcando su transición a una empresa farmacéutica en etapa clínica. El ensayo evaluará la seguridad, tolerabilidad y farmacocinética de CMND-100 en pacientes con Trastorno por Uso de Alcohol (AUD).
El estudio se llevará a cabo en tres prestigiosas instituciones: IMCA en Israel, bajo la dirección del Prof. Mark Weiser, el Departamento de Psiquiatría de la Yale School of Medicine y la Johns Hopkins University School of Medicine. El ensayo también evaluará la eficacia preliminar en la reducción de los antojos y el consumo de alcohol.
CMND-100 es el candidato a fármaco oral basado en MEAI de la empresa, diseñado para ofrecer un enfoque novedoso al modular los mecanismos de recompensa asociados con el comportamiento adictivo. Esto representa un posible avance en la lucha contra la crisis global del AUD, que afecta a aproximadamente 400 millones de personas en todo el mundo y contribuye a 2.6 millones de muertes anuales según datos de la OMS.
Clearmind Medicine (Nasdaq: CMND)는 CMND-100에 대한 1/2a상 임상 시험을 시작하여 임상 단계의 제약 회사로의 전환을 알렸습니다. 이 시험은 알코올 사용 장애 (AUD) 환자에서 CMND-100의 안전성, 내약성 및 약물 동태학을 평가할 것입니다.
이 연구는 이스라엘의 IMCA, Mark Weiser 교수의 지도 아래, 예일 의과대학 정신과 및 존스 홉킨스 대학교 의과대학의 세 곳에서 진행될 것입니다. 이 시험은 또한 알코올에 대한 갈망과 소비를 줄이는 초기 효능을 평가할 것입니다.
CMND-100은 MEAI 기반의 회사 고유의 경구 약물 후보로, 중독 행동과 관련된 보상 메커니즘을 조절하여 새로운 접근 방식을 제공하도록 설계되었습니다. 이는 전 세계적으로 약 4억 명이 영향을 받는 AUD 위기를 해결하는 데 있어 잠재적인 돌파구가 될 수 있으며, WHO 데이터에 따르면 매년 260만 명의 사망에 기여하고 있습니다.
Clearmind Medicine (Nasdaq: CMND) a lancé son essai clinique de phase I/IIa pour CMND-100, marquant sa transition vers une entreprise pharmaceutique en phase clinique. L'essai évaluera la sécurité, la tolérabilité et la pharmacocinétique de CMND-100 chez des patients atteints de trouble de l'utilisation de l'alcool (AUD).
L'étude sera réalisée dans trois institutions prestigieuses : l'IMCA en Israël, dirigée par le Prof. Mark Weiser, le Département de psychiatrie de la Yale School of Medicine et la Johns Hopkins University School of Medicine. L'essai évaluera également l'efficacité préliminaire dans la réduction des envies et de la consommation d'alcool.
CMND-100 est le candidat médicament oral propriétaire de l'entreprise, basé sur le MEAI, conçu pour offrir une approche novatrice en modulant les mécanismes de récompense associés aux comportements addictifs. Cela représente une avancée potentielle dans la lutte contre la crise mondiale de l'AUD, qui touche environ 400 millions de personnes dans le monde et contribue à 2,6 millions de décès par an selon les données de l'OMS.
Clearmind Medicine (Nasdaq: CMND) hat seine Phase I/IIa-Studie für CMND-100 gestartet, was den Übergang zu einem klinischen Pharmaunternehmen markiert. Die Studie wird die Sicherheit, Verträglichkeit und Pharmakokinetik von CMND-100 bei Patienten mit Alkoholkonsumstörung (AUD) bewerten.
Die Studie wird an drei angesehenen Institutionen durchgeführt: IMCA in Israel unter der Leitung von Prof. Mark Weiser, der Abteilung für Psychiatrie der Yale School of Medicine und der Johns Hopkins University School of Medicine. Der Versuch wird auch die vorläufige Wirksamkeit bei der Reduzierung von Alkoholverlangen und -konsum bewerten.
CMND-100 ist der firmeneigene orale Wirkstoffkandidat auf MEAI-Basis, der entwickelt wurde, um einen neuartigen Ansatz zu bieten, indem er die Belohnungsmechanismen moduliert, die mit suchtbezogenem Verhalten verbunden sind. Dies stellt einen potenziellen Durchbruch bei der Bekämpfung der globalen AUD-Krise dar, die schätzungsweise 400 Millionen Menschen weltweit betrifft und laut WHO-Daten jährlich zu 2,6 Millionen Todesfällen beiträgt.
- First-ever human clinical trial initiation for CMND-100
- Partnership with three prestigious research institutions
- Addressing large market opportunity with 400 million affected by AUD globally
- No human efficacy data available yet
- Early-stage clinical development with uncertain outcomes
Insights
Clearmind Medicine's initiation of their Phase I/IIa clinical trial for CMND-100 marks a critical transition from preclinical to clinical-stage status - a significant milestone in biotech development. This first-in-human trial investigating their proprietary psychedelic-derived therapeutic for Alcohol Use Disorder (AUD) will be conducted at prestigious institutions including Israel's IMCA Center, Yale School of Medicine, and Johns Hopkins University.
The trial design is comprehensive, evaluating safety, tolerability, and pharmacokinetics while including preliminary efficacy assessments on alcohol cravings and consumption. CMND-100's novel mechanism targeting reward pathways associated with addiction represents a differentiated approach in a field with effective treatment options.
The market opportunity is substantial, with
The company's ability to advance to clinical trials with a promising candidate while securing collaboration with world-class research institutions demonstrates solid scientific development execution. For investors, this milestone substantially derisks the company's platform technology and provides a clear development pathway, though typical early-stage clinical risks remain.
Study represents the first clinical application of CMND-100, the Company’s proprietary drug platform
Vancouver, Canada, March 18, 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, announces today that it initiated its Phase I/IIa clinical trial investigating the safety, tolerability and full pharmacokinetic profile of its 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.
The first site to be initiated is IMCA in Israel and will be led by Prof. Mark Weiser, head of the Psychiatric Division at the Sheba Medical Center, whose specializations include cognitive impairment in persons with psychiatric disorders, such as substance abuse, depression and personality disorders.
“Transitioning to a clinical stage pharmaceutical company is a major milestone for our Company, enabling us to evaluate whether the promising results from our animal studies will translate to human clinical trial participants with AUD,” said Adi Zuloff-Shani, Ph.D., Clearmind’ s Chief Executive Officer. “Previously announced preclinical data on alcohol curb supports the potential ofCMND-100 as a novel and effective treatment approach for alcoholism, addressing a significant unmet medical need.”
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.
In addition to the IMCA Center in Israel, the trial will be conducted at two prestigious U.S. research institutions, Yale School of Medicine’s Department of Psychiatry and Johns Hopkins University School of Medicine.
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.
Addressing the Global Alcohol Use Disorder Crisis
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. 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
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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 transitioning to a clinical stage pharmaceutical company and the potential for CMND-100 to provide a novel, effective approach to alcoholism treatment, addressing a major unmet medical need. 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, 2023 filed 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 Phase I/IIa trial for CMND-100?
Where will Clearmind Medicine (CMND) conduct its CMND-100 clinical trials?
How does CMND-100 differ from traditional Alcohol Use Disorder treatments?
What is the current global impact of Alcohol Use Disorder according to the WHO statistics cited by CMND?
