Clearmind Medicine Announces IRB Approval for FDA First-In-Human Clinical Trial of CMND-100 at Second Clinical Site
Clearmind Medicine Inc. (Nasdaq: CMND) has received Institutional Review Board (IRB) approval for its Phase I/IIa clinical trial of CMND-100, a MEAI-based treatment for alcohol use disorder (AUD). This approval marks the second clinical site for the multinational, multi-center trial, which will assess the safety, tolerability, and pharmacokinetics of CMND-100.
The trial will take place at Johns Hopkins University, Yale School of Medicine, and IMCA Center in Israel. Clearmind has already secured FDA approval for its Investigational New Drug (IND) application in the U.S. and approval from the Israeli Ministry of Health.
The primary endpoint of the trial is to determine the tolerable dose and evaluate the safety, pharmacokinetics, and pharmacodynamics of CMND-100. This milestone brings Clearmind closer to offering a potential solution for AUD, which is a major global health issue and the most common substance use disorder among people aged 12 and older in the U.S.
Clearmind Medicine Inc. (Nasdaq: CMND) ha ricevuto l'approvazione dal Comitato Etico Istituzionale (IRB) per il suo studio clinico di fase I/IIa sul CMND-100, un trattamento basato su MEAI per disturbo da uso di alcol (AUD). Questa approvazione segna il secondo sito clinico per lo studio multinazionale e multicentrale, che valuterà la sicurezza, la tollerabilità e la farmacocinetica del CMND-100.
Lo studio si svolgerà presso la Johns Hopkins University, la Yale School of Medicine e il Centro IMCA in Israele. Clearmind ha già ottenuto l'approvazione dalla FDA per la sua domanda di Nuovo Farmaco Sperimentale (IND) negli Stati Uniti e l'approvazione dal Ministero della Salute israeliano.
L'obiettivo principale dello studio è determinare la dose tollerabile e valutare la sicurezza, la farmacocinetica e la farmacodinamica del CMND-100. Questo traguardo avvicina Clearmind a offrire una potenziale soluzione per l'AUD, che rappresenta un importante problema di salute globale ed è il disturbo da uso di sostanze più comune tra le persone di età superiore ai 12 anni negli Stati Uniti.
Clearmind Medicine Inc. (Nasdaq: CMND) ha recibido la aprobación de la Junta de Revisión Institucional (IRB) para su ensayo clínico de fase I/IIa del CMND-100, un tratamiento basado en MEAI para el trastorno por consumo de alcohol (AUD). Esta aprobación marca el segundo sitio clínico para el ensayo multinacional y multicéntrico, que evaluará la seguridad, la tolerancia y la farmacocinética del CMND-100.
El ensayo se llevará a cabo en la Universidad Johns Hopkins, la Escuela de Medicina de Yale y el Centro IMCA en Israel. Clearmind ya ha asegurado la aprobación de la FDA para su solicitud de Nuevo Medicamento en Investigación (IND) en los EE. UU. y la aprobación del Ministerio de Salud de Israel.
El objetivo principal del ensayo es determinar la dosis tolerable y evaluar la seguridad, la farmacocinética y la farmacodinamia del CMND-100. Este hito acerca a Clearmind a ofrecer una posible solución para el AUD, que es un importante problema de salud global y el trastorno por uso de sustancias más común entre personas mayores de 12 años en los EE. UU.
Clearmind Medicine Inc. (Nasdaq: CMND)는 MEAI 기반의 알코올 사용 장애 (AUD) 치료제 CMND-100의 1/IIa 단계 임상 시험에 대해 기관 내 IRB(윤리 심사 위원회)의 승인을 받았습니다. 이번 승인은 다국적 다기관 임상 시험의 두 번째 임상 사이트를 의미하며, CMND-100의 안전성, 내약성 및 약리학적 동태를 평가할 것입니다.
임상 시험은 존스 홉킨스 대학교, 예일 의과대학, 이스라엘 IMCA 센터에서 진행됩니다. Clearmind는 이미 미국의 새로운 의약품 발견 신청서(IND)에 대한 FDA 승인을 확보했으며, 이스라엘 보건부의 승인을 받았습니다.
임상 시험의 주요 목표는 내약 가능한 용량을 결정하고 CMND-100의 안전성, 약리학적 동태 및 약력학을 평가하는 것입니다. 이번 이정표는 Clearmind가 AUD에 대한 잠재적 솔루션을 제공하는 데 더 가까워지게 합니다. AUD는 전 세계적으로 주요 건강 문제이며, 미국에서는 12세 이상의 사람들 사이에서 가장 흔한 물질 사용 장애입니다.
Clearmind Medicine Inc. (Nasdaq: CMND) a reçu l'approbation du Comité d'Éthique Institutionnel (IRB) pour son essai clinique de phase I/IIa sur le CMND-100, un traitement basé sur le MEAI pour le trouble lié à l'usage de l'alcool (AUD). Cette approbation marque le deuxième site clinique pour l'essai multinational et multicentrique, qui évaluera la sécurité, la tolérance et la pharmacocinétique du CMND-100.
L'essai se déroulera à la Johns Hopkins University, à la Yale School of Medicine et au Centre IMCA en Israël. Clearmind a déjà obtenu l'approbation de la FDA pour sa demande de Nouveau Médicament Expérimental (IND) aux États-Unis et l'approbation du ministère de la Santé israélien.
L'objectif principal de l'essai est de déterminer la dose tolérable et d'évaluer la sécurité, la pharmacocinétique et la pharmacodynamie du CMND-100. Cette étape rapproche Clearmind d'une solution potentielle pour l'AUD, qui constitue un problème de santé mondiale majeur et le trouble d'usage de substances le plus courant chez les personnes âgées de 12 ans et plus aux États-Unis.
Clearmind Medicine Inc. (Nasdaq: CMND) hat die Genehmigung der Institutional Review Board (IRB) für seine Phase I/IIa-Studie zum CMND-100, einer MEAI-basierten Behandlung für Alkoholkonsumstörung (AUD), erhalten. Diese Genehmigung markiert die zweite klinische Stelle für die multinationale, multizentrische Studie, die die Sicherheit, Verträglichkeit und Pharmakokinetik von CMND-100 bewerten wird.
Die Studie wird an der Johns Hopkins University, der Yale School of Medicine und dem IMCA-Zentrum in Israel durchgeführt. Clearmind hat bereits die Genehmigung der FDA für seinen Antrag auf Neuen Arzneimittelversuch (IND) in den USA und die Genehmigung des israelischen Gesundheitsministeriums erhalten.
Das Hauptziel der Studie ist es, die tolerierbare Dosis zu bestimmen und die Sicherheit, Pharmakokinetik und Pharmakodynamik von CMND-100 zu bewerten. Dieser Meilenstein bringt Clearmind näher, eine potenzielle Lösung für AUD anzubieten, das ein großes globales Gesundheitsproblem darstellt und die häufigste Substanzgebrauchsstörung bei Personen im Alter von 12 Jahren und älter in den USA ist.
- Received IRB approval for Phase I/IIa clinical trial of CMND-100
- Secured FDA approval for IND application in the U.S.
- Obtained approval from Israeli Ministry of Health
- Trial to be conducted at prestigious institutions: Johns Hopkins University and Yale School of Medicine
- None.
Insights
The IRB approval for Clearmind Medicine's Phase I/IIa clinical trial of CMND-100 is a significant step forward in the company's development pipeline. This second site approval, following the IMCA approval, demonstrates progress in the regulatory process and brings the company closer to initiating the trial. The study's focus on alcohol use disorder (AUD), a widespread health issue, positions CMND-100 in a potentially large market.
Key points to consider:
- The trial will assess safety, tolerability and pharmacokinetics of CMND-100, a MEAI-based treatment.
- Multi-center approach includes prestigious institutions like Johns Hopkins and Yale, which could lend credibility to the results.
- FDA approval for the IND application has already been secured, reducing regulatory uncertainty.
- The primary endpoint focuses on determining the tolerable dose, which is important for future efficacy studies.
While this news indicates progress, investors should note that early-stage clinical trials carry significant risks. The success of CMND-100 in treating AUD is yet to be determined and the path to market approval remains long and uncertain.
This clinical trial progress is a positive development for Clearmind Medicine, potentially enhancing its value proposition. However, the financial impact is not immediate and depends on future trial outcomes. Key financial considerations include:
- R&D expenses are likely to increase as the trial progresses, which could impact short-term financials.
- The AUD market is substantial, with significant unmet needs, presenting a large potential revenue opportunity if CMND-100 proves successful.
- Clearmind's market cap of
$5.54 million suggests it's a small-cap biotech, which typically carries higher risk and volatility. - Positive trial results could attract partnership opportunities or additional funding, potentially improving the company's financial position.
Investors should monitor cash burn rate and funding status, as early-stage biotechs often require additional capital raises. The company's ability to advance CMND-100 through clinical stages efficiently will be important for long-term value creation.
FDA approval for the IND submission to conduct its trial already secured
Vancouver, Canada, Oct. 10, 2024 (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 it has received Institutional Review Board (IRB) approval from one of its clinical sites in the U.S. for part A of its Phase I/IIa clinical trial in the United States for treating patients suffering from alcohol use disorder (AUD).
The multinational, multi-center trial will assess the safety, tolerability, and pharmacokinetics of Clearmind’s innovative MEAI-based (5-methoxy-2-aminoindane) treatment, CMND-100. In addition to Johns Hopkins University, Maryland, USA, the trial will also take place at Yale School of Medicine, Connecticut, USA and IMCA Center in Ramat Gan, Israel. The Company has already secured FDA approval for its Investigational New Drug (IND) application to conduct the trial in the U.S., as well as approval from the Israeli Ministry of Health. IMCA’s IRB approval has also been granted.
Dr. Adi Zuloff-Shani, CEO of Clearmind Medicine, commented: “IRB approval marks another key milestone towards the launch of our Phase I/IIa clinical trial for alcohol use disorder. Together with the IMCA approval, this becomes our second approved site, bringing us closer to offering hope to those suffering from the devastating effects of alcohol addiction. Alcohol abuse is a major global health issue and one of the leading preventable causes of death, particularly in the U.S., where AUD is the most common substance use disorder among people aged 12 and older1.”
The primary endpoint of the trial, titled A Phase I/II Single and Multiple Dose Tolerability, Safety and Pharmacokinetic Study of CMND-100 in Healthy Volunteers and Subjects with Alcohol Use Disorder (AUD), is to determine the tolerable dose and evaluate the safety, pharmacokinetics, and pharmacodynamics of CMND-100. More information is available at clinicaltrials.gov.
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 29 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
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 the potential to bring hope to those suffering from the devastating addiction to alcohol. The Company cannot assure that any patent will issue as a result of a pending patent application or, if issued, whether it will issue in a form that will be advantageous to the Company. 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.
| 1 https://www.cdc.gov/alcohol/facts-stats/index.html |
FAQ
What is the purpose of Clearmind Medicine's Phase I/IIa clinical trial for CMND-100?
Where will Clearmind Medicine (CMND) conduct its clinical trial for CMND-100?
What approvals has Clearmind Medicine (CMND) received for its CMND-100 clinical trial?
What is the primary endpoint of Clearmind Medicine's (CMND) Phase I/IIa trial for CMND-100?
