Clearmind Medicine Completes the Initiation of its Alcohol Use Disorder Phase I/IIa Clinical Trial at all Current Clinical Sites
Clearmind Medicine (NASDAQ: CMND) has completed the initiation of all planned sites for its Phase I/IIa clinical trial in Alcohol Use Disorder (AUD), including the Yale School of Medicine's Department of Psychiatry. The company has secured all necessary preparations, including FDA approval for the Investigational New Drug (IND), Institutional Review Board (IRB) approvals, and the implementation of an Electronic Data Capture (EDC) system.
The trial will be conducted at three locations: Yale School of Medicine led by Dr. Anahita Bassir Nia, Johns Hopkins University School of Medicine, and the IMCA Center in Israel. The study will evaluate CMND-100, the company's drug candidate, which has been successfully manufactured and imported into the United States. The company is now ready to begin patient enrollment for this innovative treatment targeting alcoholism.
Clearmind Medicine (NASDAQ: CMND) ha completato l'avvio di tutti i siti previsti per il suo studio clinico di Fase I/IIa sul Disturbo da Uso di Alcol (AUD), incluso il Dipartimento di Psichiatria della Yale School of Medicine. L'azienda ha ottenuto tutte le autorizzazioni necessarie, tra cui l'approvazione FDA per il Nuovo Farmaco Sperimentale (IND), le approvazioni del Comitato Etico (IRB) e l'implementazione di un sistema di Acquisizione Elettronica dei Dati (EDC).
La sperimentazione si svolgerà in tre sedi: la Yale School of Medicine guidata dalla Dott.ssa Anahita Bassir Nia, la Johns Hopkins University School of Medicine e il Centro IMCA in Israele. Lo studio valuterà CMND-100, il candidato farmaco dell'azienda, già prodotto con successo e importato negli Stati Uniti. Ora l'azienda è pronta ad avviare il reclutamento dei pazienti per questo trattamento innovativo contro l'alcolismo.
Clearmind Medicine (NASDAQ: CMND) ha completado el inicio de todos los sitios planificados para su ensayo clínico de Fase I/IIa en Trastorno por Consumo de Alcohol (AUD), incluyendo el Departamento de Psiquiatría de la Escuela de Medicina de Yale. La compañía ha asegurado todos los preparativos necesarios, incluyendo la aprobación de la FDA para el Nuevo Medicamento en Investigación (IND), aprobaciones del Comité Institucional de Revisión (IRB) y la implementación de un sistema de Captura Electrónica de Datos (EDC).
El ensayo se llevará a cabo en tres ubicaciones: la Escuela de Medicina de Yale liderada por la Dra. Anahita Bassir Nia, la Escuela de Medicina de la Universidad Johns Hopkins y el Centro IMCA en Israel. El estudio evaluará CMND-100, el candidato a medicamento de la compañía, que ha sido producido con éxito e importado a los Estados Unidos. La empresa está ahora lista para comenzar la inscripción de pacientes para este innovador tratamiento dirigido al alcoholismo.
Clearmind Medicine (NASDAQ: CMND)는 알코올 사용 장애(AUD)에 대한 1/2a상 임상시험을 위한 모든 예정된 사이트 개시를 완료했으며, 예일 의과대학 정신의학과도 포함되어 있습니다. 회사는 임상시험용 신약(IND)에 대한 FDA 승인, 기관 심사 위원회(IRB) 승인, 전자 데이터 수집(EDC) 시스템 도입 등 필요한 모든 준비를 마쳤습니다.
임상시험은 예일 의과대학의 Dr. Anahita Bassir Nia가 이끄는 팀, 존스 홉킨스 대학교 의과대학, 이스라엘 IMCA 센터 등 세 곳에서 진행됩니다. 이 연구는 회사의 약물 후보인 CMND-100을 평가할 예정이며, 해당 약물은 성공적으로 제조되어 미국으로 수입되었습니다. 회사는 이제 알코올중독 치료를 목표로 하는 이 혁신적인 치료제의 환자 등록을 시작할 준비가 되었습니다.
Clearmind Medicine (NASDAQ : CMND) a finalisé le lancement de tous les sites prévus pour son essai clinique de phase I/IIa sur le trouble lié à l'usage d'alcool (AUD), y compris le département de psychiatrie de la Yale School of Medicine. La société a obtenu toutes les préparations nécessaires, notamment l'approbation de la FDA pour le médicament en cours d'investigation (IND), les autorisations du comité d'éthique (IRB) et la mise en place d'un système de saisie électronique des données (EDC).
L'essai se déroulera sur trois sites : la Yale School of Medicine dirigée par le Dr Anahita Bassir Nia, la Johns Hopkins University School of Medicine et le centre IMCA en Israël. L'étude évaluera CMND-100, le candidat médicament de la société, qui a été fabriqué avec succès et importé aux États-Unis. La société est désormais prête à commencer le recrutement des patients pour ce traitement innovant ciblant l'alcoolisme.
Clearmind Medicine (NASDAQ: CMND) hat die Einrichtung aller geplanten Standorte für seine Phase I/IIa-Studie zur Alkoholgebrauchsstörung (AUD) abgeschlossen, einschließlich der Abteilung für Psychiatrie der Yale School of Medicine. Das Unternehmen hat alle erforderlichen Vorbereitungen getroffen, darunter die FDA-Zulassung für das Prüfpräparat (IND), die Genehmigungen der Ethikkommission (IRB) sowie die Implementierung eines elektronischen Datenerfassungssystems (EDC).
Die Studie wird an drei Standorten durchgeführt: der Yale School of Medicine unter der Leitung von Dr. Anahita Bassir Nia, der Johns Hopkins University School of Medicine und dem IMCA-Zentrum in Israel. Untersucht wird CMND-100, der Arzneimittelkandidat des Unternehmens, der erfolgreich hergestellt und in die USA importiert wurde. Das Unternehmen ist nun bereit, mit der Patientenrekrutierung für diese innovative Behandlung gegen Alkoholismus zu beginnen.
- FDA approval secured for Phase I/IIa clinical trial
- All planned trial sites successfully initiated at prestigious institutions
- Drug candidate CMND-100 successfully manufactured and imported
- Ready to begin patient enrollment
- Early-stage clinical trial with no proven efficacy yet
- Results and timeline for patient enrollment remain uncertain
Insights
Clearmind advances novel psychedelic therapy for alcoholism to clinical testing phase at prestigious research institutions, marking critical development milestone.
This announcement represents a significant milestone in Clearmind's clinical development program for CMND-100 in treating Alcohol Use Disorder (AUD). The company has successfully completed all necessary preparatory steps for its Phase I/IIa clinical trial, including securing FDA IND approval, obtaining IRB approvals from each clinical site, launching their EDC system, and successfully importing their drug candidate into the United States.
The trial's multi-center design spanning Yale School of Medicine, Johns Hopkins University, and the IMCA Center in Israel adds considerable scientific credibility to the study. Having Dr. Bassir Nia, a specialist in substance abuse, leading the Yale site further strengthens the trial's execution capabilities.
This activation of all clinical sites enables immediate progression to patient enrollment - a crucial step in determining whether CMND-100 shows promise in human subjects. Phase I/IIa trials primarily establish safety parameters while beginning to generate preliminary efficacy signals for AUD, which affects millions globally with effective treatment options.
The psychedelic-derived therapeutic approach represents an innovative direction in addiction treatment, potentially addressing neurobiological aspects of AUD that conventional therapies may not target effectively. This trial will provide the first human data for CMND-100, essential for determining whether the compound warrants further development through the clinical pipeline.
Clearmind advances from preclinical to clinical stage with alcoholism treatment trial, creating potential value inflection point despite early development phase.
Clearmind Medicine's transition from preclinical to clinical-stage development represents a crucial inflection point for this
The company's robust intellectual property portfolio, comprising 19 patent families with 31 granted patents, provides potential long-term market exclusivity if development succeeds. The collaboration with world-renowned research institutions enhances scientific credibility and execution capabilities for this critical first human trial.
Alcohol Use Disorder represents a substantial market opportunity with significant unmet medical need. Current pharmacological interventions show effectiveness, creating an opening for novel therapeutic approaches. The psychedelic medicine sector has gained increasing scientific legitimacy, with several compounds progressing through clinical trials for various neuropsychiatric conditions.
For Clearmind, site activation enables progression to patient enrollment - the next critical milestone. While this news demonstrates operational execution, the company faces the typical challenges of early-stage clinical development, including technical risk and the need for positive data to support continued advancement. Successfully generating promising human data would significantly enhance Clearmind's strategic position as it seeks to address this widespread public health challenge.
The Company is now preparing for the enrollment of the first patient to receive Clearmind’s innovative treatment as part of the trial
Vancouver, Canada, April 23, 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 initiation of its U.S. clinical trial site at the Yale School of Medicine’s Department of Psychiatry. With this initiation, the Company has now activated all planned sites for its clinical trial for its Phase I/IIa clinical trial in Alcohol Use Disorder (“AUD”) and can begin patient enrollment .Clearmind has completed all necessary preparations for the clinical trial, including obtaining Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) to start the Phase I/IIa clinical trial, Institutional Review Board (IRB) approvals from each clinical site, launch of its Electronic Data Capture (EDC) system to support the clinical trial and the arrival of its drug candidate, CMND-100, into the United States following successful manufacturing.
The trial in Yale School of Medicine’s Department of Psychiatry will be led by Dr. Anahita Bassir Nia, M.D., a specialist in substance abuse, including alcohol abuse. The trial will also be conducted at the Johns Hopkins University School of Medicine in the U.S. and at the IMCA Center in Israel.
“AUD remains one of the most urgent and underserved public health challenges globally,” said Dr. Adi Zuloff-Shani, Chief Executive Officer of Clearmind Medicine. “With millions affected and current treatments often falling short, the study initiation for our FDA-approved CMND-100 trial marks a critical step toward potentially transforming the treatment landscape for alcoholism. We are honored to collaborate with world renowned institutions such as Yale and Johns Hopkins as we advance our mission to potentially provide safe, effective, and innovative solutions for individuals those suffering from alcoholism.”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 potentially transforming alcoholism treatment landscape and its mission to potentially provide safe, effective, and innovative solutions for those suffering from alcoholism. 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 current status of Clearmind Medicine's (CMND) Phase I/IIa clinical trial for Alcohol Use Disorder?
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What is the drug candidate being tested in Clearmind Medicine's AUD clinical trial?
