Clearmind Medicine Announces Positive Top-Line Results from First Cohort of its FDA-Approved Phase I/IIa Clinical Trial for Alcohol Use Disorder
Clearmind Medicine (NASDAQ: CMND) announced positive top-line results from the first cohort of its FDA-approved Phase I/IIa trial of CMND-100, a non-hallucinogenic MEAI-based oral candidate for Alcohol Use Disorder (AUD), on November 18, 2025. The six-patient first cohort showed a favorable safety profile with no serious adverse events reported and generally good tolerability. Investigators also reported high treatment adherence, supporting feasibility and patient acceptability. Dosing was completed at Johns Hopkins and Yale under the multicenter, single- and multiple-dose protocol; the company will continue evaluation in subsequent cohorts toward a full data readout.
Clearmind Medicine (NASDAQ: CMND) ha annunciato risultati positivi della linea principale dalla prima coorte del suo trial di fase I/IIa approvato dalla FDA di CMND-100, un candidato orale non allucinogeno a base di MEAI per il Disturbo da uso di alcol (AUD), 18 novembre 2025. La prima coorte di sei pazienti ha mostrato un profilo di sicurezza favorevole con nessun evento avverso grave riportato e una tollerabilità generalmente buona. Gli investigatori hanno inoltre riportato alta aderenza al trattamento, a sostegno della fattibilità e dell'accettabilità da parte dei pazienti. La somministrazione è stata completata presso Johns Hopkins e Yale secondo il protocollo multicentrico, a dosi singole e multiple; l'azienda continuerà la valutazione nelle coorti successive verso una lettura completa dei dati.
Clearmind Medicine (NASDAQ: CMND) anunció resultados positivos de la línea principal de la primera cohorte de su ensayo de Fase I/IIa aprobado por la FDA de CMND-100, un candidato oral no alucinógeno basado en MEAI para el trastorno por consumo de alcohol (AUD), el 18 de noviembre de 2025. La primera cohorte de seis pacientes mostró un perfil de seguridad favorable con ningún evento adverso grave reportado y una tolerabilidad generalmente buena. Los investigadores también informaron una alta adherencia al tratamiento, respaldando la viabilidad y la aceptabilidad por parte de los pacientes. La dosificación se completó en Johns Hopkins y Yale bajo el protocolo multicéntrico, de dosis única y múltiple; la empresa continuará la evaluación en cohortes subsiguientes hacia una lectura completa de los datos.
Clearmind Medicine (NASDAQ: CMND)는 FDA 승인 1상/2a상 임상시험의 첫 코호트에서 CMND-100에 대한 긍정적 상단선 결과를 발표했습니다. CMND-100은 알코올 사용 장애(AUD)를 위한 비환각성 MEAI 기반 경구 후보물질이며, 2025년 11월 18일에 발표되었습니다. 여섯 명으로 구성된 첫 코호트는 유리한 안전성 프로파일을 보였고 중대한 이상 반응 없음이 보고되었으며 일반적으로 양호한 내약성을 보였습니다. 연구자들은 또한 높은 치료 순응도를 보고해 치료의 실행 가능성과 환자 수용성을 뒷받침합니다. 투여는 Johns Hopkins와 Yale에서 다기관 다중용량 프로토콜 아래 완료되었으며, 회사는 전체 데이터 공개를 향해 후속 코호트에서도 평가를 계속합니다.
Clearmind Medicine (NASDAQ : CMND) a annoncé des résultats positifs de la ligne principale du premier cohorte de son essai de phase I/IIa approuvé par la FDA pour CMND-100, un candidat oral non hallucinogène basé sur le MEAI pour le trouble lié à l’usage d’alcool (AUD), le 18 novembre 2025. La première cohorte de six patients a montré un profil de sécurité favorable avec aucun événement indésirable grave et une tolérance généralement bonne. Les investigateurs ont également signalé une forte adhérence au traitement, soutenant la faisabilité et l’acceptabilité par les patients. La posologie a été complétée à Johns Hopkins et Yale selon le protocole multicentrique, à dose unique et multiple; l’entreprise poursuivra l’évaluation dans les cohortes suivantes jusqu’à une diffusion complète des données.
Clearmind Medicine (NASDAQ: CMND) kündigte positive Topline-Ergebnisse aus der ersten Kohorte ihrer FDA-genehmigten Phase-I/IIa-Studie von CMND-100 an, einem nicht-halluzinogenen MEAI-basierten oralen Kandidaten für Alkoholgebrauchsstörung (AUD), am 18. November 2025. Die sechs Patienten der ersten Kohorte zeigten ein günstiges Sicherheitsprofil mit keinen schweren unerwünschten Ereignissen und allgemein guter Verträglichkeit. Die Untersucher meldeten außerdem eine hohe Therapietreue, was Machbarkeit und Akzeptanz durch die Patienten unterstützt. Die Verabreichung wurde an der Johns Hopkins University und Yale gemäß dem multizentrischen Protokoll mit Ein- und Mehrfachdosierungen abgeschlossen; das Unternehmen wird die Bewertung in folgenden Kohorten fortsetzen, bis eine vollständige Datenauswertung vorliegt.
Clearmind Medicine (NASDAQ: CMND) أعلنت عن نتائج إيجابية من الشوط الأول من تجربتها في المرحلة I/IIa المعتمدة من FDA لـ CMND-100، وهو مرشح فموي قائم على MEAI غير هلوسي لاضطراب استخدام الكحول (AUD)، في 18 نوفمبر 2025. أظهر الشوط الأول المكوّن من ستة مرضى ملف سلامة إيجابي مع عدم وجود أحداث سلبية خطيرة وعمومًا تحمل جيد. كما أفاد الباحثون بـ التزام عالٍ بالعلاج، مما يدعم الجدوى وقبول المرضى. تم إنهاء الجرعات في Johns Hopkins و Yale وفق بروتوكول متعدد المراكز، أحادي ومتعدد الجرعات؛ ستواصل الشركة التقييم في الكوفوت لاحقة وصولاً إلى قراءة كاملة للبيانات.
- No serious adverse events reported in first cohort (n=6)
- High treatment adherence and protocol observance in cohort
- Dosing completed at Johns Hopkins and Yale under FDA-approved protocol
- Small cohort size of 6 patients limits statistical conclusions
- No quantitative efficacy data disclosed in top-line announcement
Insights
Top-line safety and adherence data from the first cohort show a favorable early signal for CMND-100 in AUD.
Clearmind reports that the FDA‑approved Phase I/IIa first cohort completed dosing with six participants across two academic centers and showed no serious adverse events and generally good tolerability. The report also states high adherence to the dosing regimen and protocol, which supports feasibility of the oral, non‑hallucinogenic MEAI‑based candidate in a controlled clinical setting.
Key dependencies include completion of subsequent cohorts and the full data readout to confirm safety across a larger sample and to provide meaningful efficacy signals; the current facts are limited to top‑line safety and observance only. Watch for the complete cohort datasets, pharmacokinetic results, and any reported preliminary efficacy endpoints in the next scheduled readouts, which will determine whether this early momentum translates into clear clinical development value.
Vancouver, Canada, Nov. 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 neuroplastogen-derived therapeutics to solve major under-treated health problems, today announced positive top-line results from the first cohort of its Phase I/IIa clinical trial evaluating CMND-100, the Company’s proprietary non-hallucinogenic MEAI-based oral drug candidate for the treatment of Alcohol Use Disorder (AUD).
The top-line data from the first cohort demonstrate a favorable safety profile, with no serious adverse events reported and the treatment generally well-tolerated across all participants. Additionally, the cohort showed strong treatment observance, with high adherence to the dosing regimen and protocol requirements, underscoring the feasibility and patient acceptability of CMND-100 in a clinical setting. These encouraging early findings support the ongoing evaluation of CMND-100 as a potential breakthrough therapy for AUD, a condition affecting millions worldwide where effective treatments remain limited.
These results build on the Company’s previous announcement on October 30, 2025, regarding the successful completion of dosing in the first cohort, where six patients were enrolled and treated—two at Johns Hopkins University School of Medicine and four at Yale School of Medicine’s Department of Psychiatry. The multinational, multicenter trial, conducted under the U.S. Food and Drug Administration (FDA)-approved clinical protocol, is designed as a single- and multiple-dose study to assess the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of CMND-100 in participants with heavy binge drinking or AUD.
“We are thrilled with these initial top-line results from the first cohort, which “indicate an encouraging safety profile and excellent treatment observance of CMND-100,” said Dr. Adi Zuloff-Shani, Chief Executive Officer of Clearmind Medicine. “Building on our recent milestone of completing dosing at premier institutions like Johns Hopkins and Yale, these data provide strong momentum as we advance toward full data readout and subsequent cohorts. Our goal remains to pioneer neuroplastogen -derived therapies that offer real hope to those battling addiction, and these results bring us one step closer to that vision.”
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 the ongoing evaluation and clinical development of its product candidates, advancing toward full data readout and subsequent cohorts, pioneering neuroplastogen -derived therapies, and seeking additional patents for its compounds. 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, 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 did Clearmind (CMND) announce on November 18, 2025 about CMND-100?
How many patients were in Clearmind's first CMND-100 cohort and where were they treated?
Does the November 18, 2025 update include efficacy results for CMND-100 (CMND)?
Is Clearmind's CMND-100 trial FDA-approved and what is its design?
What does 'no serious adverse events' mean for CMND-100 investors in the November 18, 2025 release?
What are the next steps after Clearmind's first cohort top-line results for CMND-100 (CMND)?
