Clearmind Medicine’s FDA-Approved Clinical Trial for CMND-100 Moves Forward as Drug Arrives in the U.S., Advancing Toward Key Milestones
Clearmind Medicine (Nasdaq: CMND) has reached a significant milestone as its drug candidate CMND-100 arrives in the United States, preparing for its FDA-approved Phase I/IIa clinical trial for Alcohol Use Disorder (AUD) treatment.
The clinical trial will evaluate CMND-100, a proprietary MEAI-based oral drug candidate, for safety and efficacy in reducing alcohol consumption. The study will be conducted at prestigious institutions including Yale School of Medicine's Department of Psychiatry, Johns Hopkins University School of Medicine, and IMCA in Ramat Gan, Israel.
The company is targeting a significant market opportunity, as AUD affects over 28 million adults in the U.S., with an estimated global market potential of $35 billion. CMND-100 aims to reduce alcohol consumption and cravings through a novel mechanism of action.
Clearmind Medicine (Nasdaq: CMND) ha raggiunto un traguardo significativo poiché il suo candidato farmaco CMND-100 è arrivato negli Stati Uniti, preparando per il trial clinico di Fase I/IIa approvato dalla FDA per il trattamento del Disturbo da Uso di Alcol (AUD).
Il trial clinico valuterà CMND-100, un candidato farmaco orale a base di MEAI, per la sicurezza e l'efficacia nella riduzione del consumo di alcol. Lo studio sarà condotto in prestigiose istituzioni tra cui il Dipartimento di Psichiatria della Yale School of Medicine, la Johns Hopkins University School of Medicine e IMCA a Ramat Gan, Israele.
L'azienda sta puntando a un'importante opportunità di mercato, poiché l'AUD colpisce oltre 28 milioni di adulti negli Stati Uniti, con un potenziale di mercato globale stimato di 35 miliardi di dollari. CMND-100 mira a ridurre il consumo di alcol e le voglie attraverso un meccanismo d'azione innovativo.
Clearmind Medicine (Nasdaq: CMND) ha alcanzado un hito significativo ya que su candidato a medicamento CMND-100 ha llegado a los Estados Unidos, preparándose para su ensayo clínico de Fase I/IIa aprobado por la FDA para el tratamiento del Trastorno por Consumo de Alcohol (AUD).
El ensayo clínico evaluará CMND-100, un candidato a medicamento oral basado en MEAI, por su seguridad y eficacia en la reducción del consumo de alcohol. El estudio se llevará a cabo en instituciones prestigiosas, incluyendo el Departamento de Psiquiatría de la Yale School of Medicine, la Johns Hopkins University School of Medicine y IMCA en Ramat Gan, Israel.
La empresa está apuntando a una oportunidad de mercado significativa, ya que el AUD afecta a más de 28 millones de adultos en los EE. UU., con un potencial de mercado global estimado en 35 mil millones de dólares. CMND-100 tiene como objetivo reducir el consumo de alcohol y los antojos a través de un novedoso mecanismo de acción.
Clearmind Medicine (Nasdaq: CMND)는 자사의 약물 후보 CMND-100가 미국에 도착하여 알코올 사용 장애 (AUD) 치료를 위한 FDA 승인 1/2a 단계 임상 시험을 준비함에 따라 중요한 이정표에 도달했습니다.
이 임상 시험은 CMND-100, MEAI 기반의 독점 구강 약물 후보의 안전성과 알코올 소비 감소의 효능을 평가할 것입니다. 연구는 예일 의대 정신과, 존스 홉킨스 의대, 이스라엘 라마트 간의 IMCA를 포함한 권위 있는 기관에서 진행될 것입니다.
회사는 AUD가 미국에서 2800만 명 이상의 성인에게 영향을 미치고 있으며, 전 세계적으로 350억 달러의 시장 잠재력이 있는 중요한 시장 기회를 목표로 하고 있습니다. CMND-100은 새로운 작용 메커니즘을 통해 알코올 소비와 갈망을 줄이는 것을 목표로 합니다.
Clearmind Medicine (Nasdaq: CMND) a atteint une étape importante alors que son candidat médicament CMND-100 arrive aux États-Unis, se préparant pour son essai clinique de Phase I/IIa approuvé par la FDA pour le traitement du trouble lié à l'usage de l'alcool (AUD).
L'essai clinique évaluera CMND-100, un candidat médicament oral à base de MEAI, pour sa sécurité et son efficacité dans la réduction de la consommation d'alcool. L'étude sera réalisée dans des institutions prestigieuses, y compris le Département de psychiatrie de la Yale School of Medicine, la Johns Hopkins University School of Medicine et IMCA à Ramat Gan, en Israël.
L'entreprise vise une opportunité de marché significative, car l'AUD touche plus de 28 millions d'adultes aux États-Unis, avec un potentiel de marché mondial estimé à 35 milliards de dollars. CMND-100 vise à réduire la consommation d'alcool et les envies grâce à un mécanisme d'action novateur.
Clearmind Medicine (Nasdaq: CMND) hat einen bedeutenden Meilenstein erreicht, da sein Arzneimittelkandidat CMND-100 in den Vereinigten Staaten angekommen ist und sich auf die FDA-zugelassene Phase I/IIa-Studie zur Behandlung von Alkoholkonsumstörung (AUD) vorbereitet.
Die klinische Studie wird CMND-100, einen proprietären MEAI-basierten oralen Arzneimittelkandidaten, hinsichtlich Sicherheit und Wirksamkeit bei der Reduzierung des Alkoholkonsums evaluieren. Die Studie wird an renommierten Institutionen durchgeführt, darunter die Psychiatrische Abteilung der Yale School of Medicine, die Johns Hopkins University School of Medicine und IMCA in Ramat Gan, Israel.
Das Unternehmen zielt auf eine bedeutende Marktchance ab, da AUD über 28 Millionen Erwachsene in den USA betrifft, mit einem geschätzten globalen Marktpotenzial von 35 Milliarden Dollar. CMND-100 zielt darauf ab, den Alkoholkonsum und die Gelüste durch einen neuartigen Wirkmechanismus zu reduzieren.
- FDA approval received for Phase I/IIa clinical trial
- Partnerships with prestigious research institutions (Yale and Johns Hopkins)
- Large market opportunity: $35B global AUD treatment market
- Significant addressable patient population: 28M+ adults with AUD in U.S.
- Early-stage clinical trial - no proven efficacy yet
- No revenue generation at current stage
Insights
Clearmind Medicine has reached a logistical milestone in its clinical development program with CMND-100 arriving in the US for its FDA-approved Phase I/IIa clinical trial for Alcohol Use Disorder. This operational progress keeps their development timeline on track, demonstrating execution capability in advancing their lead asset.
The company is targeting a substantial clinical need with AUD affecting over 28 million adults in the US alone. Their proprietary MEAI-based oral candidate employs a novel mechanism of action focused on reducing alcohol consumption and cravings – potentially differentiating it from existing treatments in this space.
The trial's credibility is enhanced by its planned implementation at prestigious research institutions including Yale and Johns Hopkins. This partnership with leading addiction research centers could strengthen data quality and scientific validation.
While this milestone demonstrates operational progress, investors should recognize this remains an early-stage program. Phase I/IIa trials primarily establish safety parameters and preliminary efficacy signals rather than definitive therapeutic validation. The
This milestone confirms Clearmind is executing its stated development strategy and maintaining regulatory momentum with an FDA-approved trial design, a positive indicator of operational health for a clinical-stage biotech company.
The arrival of CMND-100 in the United States represents meaningful operational progress for Clearmind Medicine as it prepares to initiate its first-in-human clinical study. In pharmaceutical development, successful logistics and manufacturing completion are critical precursors to clinical execution.
What's particularly notable is Clearmind's strategic positioning in the psychedelic-derived therapeutics space focused on Alcohol Use Disorder – a condition with significant unmet need despite its prevalence. The company is pursuing a differentiated approach with its proprietary MEAI-based compound compared to traditional AUD interventions.
The multi-site trial design spanning major US research institutions (Yale and Johns Hopkins) plus an Israeli center (IMCA) suggests a robust clinical approach. This international, multi-center strategy typically generates more compelling and generalizable data than single-site studies.
From a market perspective, the
While this milestone confirms operational execution, it's important to contextualize this within the lengthy pharmaceutical development process. Phase I/IIa studies are early investigations primarily focused on safety assessment with preliminary efficacy signals. Significant clinical, regulatory, and commercial hurdles remain before determining whether CMND-100 could become a viable treatment option for AUD patients.
Vancouver, Canada, March 21, 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 its innovative drug candidate, CMND-100, has arrived in the United States following successful manufacturing. This marks a key milestone as the Company prepares to initiate its FDA-approved Phase I/IIa clinical trial for the treatment of Alcohol Use Disorder (AUD), a condition affecting over 28 million adults in the U.S. alone.
CMND-100, a proprietary MEAI-based oral drug candidate, represents a potential breakthrough in AUD treatment, targeting the reduction of alcohol consumption and cravings through a novel mechanism of action. The drug’s arrival in the U.S. keeps Clearmind on track to launch its first-in-human clinical trial.
"This milestone brings us closer to demonstrating CMND-100’s potential as a transformative treatment for Alcohol Use Disorder," said Dr. Adi Zuloff-Shani, CEO of Clearmind Medicine. “With an estimated
Clearmind’s Phase I/IIa clinical trial, approved by the U.S. Food and Drug Administration (FDA), will assess CMND-100’s safety and efficacy in reducing alcohol consumption. The study will be conducted at two of the leading research institutions in the United States, Yale School of Medicine’s Department of Psychiatry and Johns Hopkins University School of Medicine. The Israeli trial will be conducted at IMCA (Israel Medical Center for Addiction), located in Ramat Gan, Israel.
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:
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