Clearmind Launches its EDC System to Support its Phase I/II Clinical Trial of its MEAI-Based Treatment
Clearmind Medicine (Nasdaq: CMND) has launched its Electronic Data Capture (EDC) system for its Phase I/II clinical trial evaluating a MEAI-based treatment for Alcohol Use Disorder (AUD). The EDC system represents a important operational milestone, enabling:
- Real-time, secure data collection across study sites
- Automated edit checks and validation
- Secure randomization process
- Accurate tracking of safety events
- Informed consent procedures
- Proper patient allocation between study arms
The clinical trial aims to assess the safety, tolerability, and efficacy of Clearmind's psychedelic-derived, MEAI-based compound in individuals with alcohol addiction. The system includes separate notification flows for blinded and unblinded staff to maintain protocol compliance and trial integrity.
Clearmind Medicine (Nasdaq: CMND) ha lanciato il suo sistema di Electronic Data Capture (EDC) per il suo studio clinico di Fase I/II che valuta un trattamento a base di MEAI per il Disturbo da Uso di Alcol (AUD). Il sistema EDC rappresenta un'importante pietra miliare operativa, consentendo:
- Raccolta dati sicura e in tempo reale nei siti di studio
- Controlli automatici delle modifiche e validazione
- Processo di randomizzazione sicuro
- Monitoraggio accurato degli eventi di sicurezza
- Procedure di consenso informato
- Assegnazione corretta dei pazienti tra i gruppi di studio
Lo studio clinico mira a valutare la sicurezza, la tollerabilità e l'efficacia del composto derivato da psicoattivi e basato su MEAI in individui con dipendenza da alcol. Il sistema include flussi di notifica separati per il personale cieco e non cieco per mantenere la conformità al protocollo e l'integrità dello studio.
Clearmind Medicine (Nasdaq: CMND) ha lanzado su sistema de Captura Electrónica de Datos (EDC) para su ensayo clínico de Fase I/II que evalúa un tratamiento basado en MEAI para el Trastorno por Consumo de Alcohol (AUD). El sistema EDC representa un hito operativo importante, permitiendo:
- Recopilación de datos segura y en tiempo real en los sitios de estudio
- Controles automáticos de edición y validación
- Proceso de aleatorización seguro
- Seguimiento preciso de eventos de seguridad
- Procedimientos de consentimiento informado
- Asignación adecuada de pacientes entre los grupos de estudio
El ensayo clínico tiene como objetivo evaluar la seguridad, la tolerabilidad y la eficacia del compuesto derivado de psicodélicos y basado en MEAI en individuos con adicción al alcohol. El sistema incluye flujos de notificación separados para el personal ciego y no ciego para mantener la conformidad con el protocolo y la integridad del ensayo.
Clearmind Medicine (Nasdaq: CMND)는 알코올 사용 장애 (AUD)에 대한 MEAI 기반 치료법을 평가하는 1/2상 임상 시험을 위한 전자 데이터 수집 (EDC) 시스템을 출시했습니다. EDC 시스템은 다음을 가능하게 하는 중요한 운영 이정표를 나타냅니다:
- 연구 사이트 전반에 걸쳐 실시간 안전한 데이터 수집
- 자동 수정 확인 및 검증
- 안전한 무작위 배정 프로세스
- 안전성 사건의 정확한 추적
- 정보 제공 동의 절차
- 연구 그룹 간의 적절한 환자 배정
이 임상 시험은 알코올 중독이 있는 개인에서 Clearmind의 환각제 유래 MEAI 기반 화합물의 안전성, 내약성 및 효능을 평가하는 것을 목표로 합니다. 이 시스템은 프로토콜 준수 및 시험의 무결성을 유지하기 위해 블라인드 및 비블라인드 직원에 대한 개별 알림 흐름을 포함합니다.
Clearmind Medicine (Nasdaq: CMND) a lancé son système de Capture Électronique de Données (EDC) pour son essai clinique de Phase I/II évaluant un traitement basé sur le MEAI pour le trouble de l'utilisation de l'alcool (AUD). Le système EDC représente une étape opérationnelle importante, permettant :
- Collecte de données sécurisée en temps réel sur les sites d'étude
- Contrôles de modification automatiques et validation
- Processus de randomisation sécurisé
- Suivi précis des événements de sécurité
- Procédures de consentement éclairé
- Attribution appropriée des patients entre les bras de l'étude
L'essai clinique vise à évaluer la sécurité, la tolérabilité et l'efficacité du composé dérivé de psychédéliques et basé sur le MEAI chez des individus souffrant d'addiction à l'alcool. Le système comprend des flux de notification séparés pour le personnel aveugle et non aveugle afin de maintenir la conformité au protocole et l'intégrité de l'essai.
Clearmind Medicine (Nasdaq: CMND) hat sein Elektronisches Datenerfassungssystem (EDC) für die Phase I/II-Studie gestartet, die eine MEAI-basierte Behandlung für Alkoholkonsumstörung (AUD) bewertet. Das EDC-System stellt einen wichtigen betrieblichen Meilenstein dar, der Folgendes ermöglicht:
- Echtzeit-Sichere Datenerfassung an den Studienstandorten
- Automatisierte Änderungsprüfungen und Validierung
- Sicheren Randomisierungsprozess
- Genaues Tracking von Sicherheitsereignissen
- Informierte Einwilligungsverfahren
- Ordnungsgemäße Patientenverteilung zwischen den Studienarmen
Die klinische Studie zielt darauf ab, die Sicherheit, Verträglichkeit und Wirksamkeit der von Clearmind abgeleiteten psychedelischen MEAI-basierten Verbindung bei Personen mit Alkoholabhängigkeit zu bewerten. Das System umfasst separate Benachrichtigungsflüsse für blinde und nicht blinde Mitarbeiter, um die Einhaltung des Protokolls und die Integrität der Studie zu gewährleisten.
- Launch of EDC system marks operational progress in Phase I/II clinical trial
- Implementation of advanced data management system enhances trial efficiency and compliance
- Multi-part study design allows flexibility for future protocol amendments
- None.
Insights
Clearmind's announcement of their EDC system launch represents an operational milestone in their clinical development program, but falls short of being a significant catalyst for the company. The EDC system, while essential infrastructure for their Phase I/II trial of MEAI-based treatment for Alcohol Use Disorder (AUD), is a standard procedural step in clinical trial execution rather than a scientific achievement.
What's notable is that this confirms Clearmind is making expected progress in its clinical timeline for evaluating their psychedelic-derived compound. The implementation of randomization processes and data validation systems indicates proper trial design, which is critical for generating reliable safety and efficacy data.
From a development perspective, this announcement signals the trial's operational readiness, suggesting patient enrollment and data collection can proceed. However, investors should understand that meaningful clinical data points remain further ahead in the development timeline. The true value inflection points will come with initial safety results and preliminary efficacy signals from this Phase I/II study.
This milestone, while necessary, represents standard execution rather than accelerated progress or enhanced likelihood of clinical success. The AUD treatment market represents a significant opportunity, but this particular announcement doesn't materially change the risk profile or timeline for Clearmind's development program.
The clinical trial is designed to evaluate the safety, tolerability and efficacy of Clearmind’s innovative, psychedelic-derived, MEAI-based compound in individuals with alcohol addiction
Vancouver, Canada, April 01, 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 the launch of its Electronic Data Capture (EDC) system to support its Phase I/II clinical trial of its MEAI-based treatment for Alcohol Use Disorder (AUD). The activation of the EDC system marks a critical operational milestone, enabling real-time, secure and compliant data collection across all stages of the study.
The EDC system enables seamless data collection and real-time monitoring across all participating sites. The clinical trial is designed to evaluate the safety, tolerability and efficacy of Clearmind’s innovative, psychedelic-derived, MEAI-based compound in individuals with AUD.
The EDC system, which was custom designed for Clearmind’s clinical protocol, incorporates automated edit checks, real-time validation and a secure randomization process. The platform supports efficient and compliant data capture across multiple study parts, including future protocol amendments. It was developed to ensure accurate tracking of safety events, informed consent procedures and proper patient allocation between study arms.
As part of the clinical infrastructure, the Company finalized the randomization process, which will be managed through the EDC platform. A unique randomization number will be assigned to each participant, with separate notification flows for blinded and unblinded staff to ensure protocol compliance and trial integrity.
“The activation of our customized EDC system represents another major operational milestone for Clearmind,” said Dr. Adi Zuloff-Shani, CEO of Clearmind. “This platform is central to our ability to manage clinical data with precision, ensure compliance and maintain the integrity of our trial. Its robust design provides real-time oversight and supports the flexible structure of our multi-part study, which is critical as we advance our MEAI-based treatment through clinical development.”
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 advancing its MEAI-based treatment through clinical development. 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 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 purpose of Clearmind's (CMND) Phase I/II clinical trial?
How does CMND's new EDC system enhance their clinical trial process?
What security measures are implemented in CMND's clinical trial data collection?
How will CMND's EDC system handle patient randomization in the trial?
