Adial Pharmaceuticals Granted End of Phase 2 Meeting from the U.S. Food and Drug Administration
Adial Pharmaceuticals (NASDAQ: ADIL) has secured an End of Phase 2 meeting with the FDA, scheduled for July 25, 2025. The meeting aims to discuss the company's clinical development plan and seek guidance on the Phase 3 adaptive enrichment design for AD04, their lead investigational drug for Alcohol Use Disorder (AUD).
AD04 is a genetically targeted, serotonin-3 receptor antagonist designed to treat AUD in heavy drinking patients who consume less than 8 drinks per drinking day. The company recently achieved successful results in their Type D Meeting with FDA, confirming their 505(b)(2) regulatory bridging strategy. Adial's recent analyses have strengthened their confidence in the selected target patient population and AD04's potential effectiveness in treating AUD and related conditions.
Adial Pharmaceuticals (NASDAQ: ADIL) ha ottenuto un incontro di fine Fase 2 con la FDA, previsto per il 25 luglio 2025. L'incontro ha l'obiettivo di discutere il piano di sviluppo clinico dell'azienda e di ricevere indicazioni sul disegno adattivo di arricchimento della Fase 3 per AD04, il loro principale farmaco sperimentale per il Disturbo da Uso di Alcol (AUD).
AD04 è un antagonista del recettore della serotonina-3 geneticamente mirato, progettato per trattare l'AUD in pazienti con consumo eccessivo di alcol che bevono meno di 8 unità alcoliche per giorno di consumo. L'azienda ha recentemente ottenuto risultati positivi nel loro incontro di tipo D con la FDA, confermando la strategia regolatoria 505(b)(2). Le analisi recenti di Adial hanno rafforzato la fiducia nella popolazione target selezionata e nel potenziale di efficacia di AD04 nel trattamento dell'AUD e delle condizioni correlate.
Adial Pharmaceuticals (NASDAQ: ADIL) ha asegurado una reunión de fin de Fase 2 con la FDA, programada para el 25 de julio de 2025. La reunión tiene como objetivo discutir el plan de desarrollo clínico de la compañía y buscar orientación sobre el diseño adaptativo de enriquecimiento para la Fase 3 de AD04, su principal medicamento en investigación para el Trastorno por Consumo de Alcohol (AUD).
AD04 es un antagonista del receptor de serotonina-3 genéticamente dirigido, diseñado para tratar el AUD en pacientes con consumo excesivo de alcohol que beben menos de 8 bebidas por día de consumo. La compañía logró recientemente resultados exitosos en su reunión Tipo D con la FDA, confirmando su estrategia regulatoria 505(b)(2). Los análisis recientes de Adial han reforzado su confianza en la población objetivo seleccionada y en la potencial eficacia de AD04 para tratar el AUD y condiciones relacionadas.
Adial Pharmaceuticals (NASDAQ: ADIL)는 2025년 7월 25일로 예정된 FDA와의 2상 종료 미팅을 확보했습니다. 이 미팅은 회사의 임상 개발 계획을 논의하고, AD04의 3상 적응형 강화 설계에 대한 지침을 구하는 것을 목표로 합니다. AD04는 알코올 사용 장애(AUD) 치료를 위한 주요 임상 후보 약물입니다.
AD04는 유전적으로 표적화된 세로토닌-3 수용체 길항제로, 하루 음주량이 8잔 미만인 과음 환자의 AUD 치료를 위해 설계되었습니다. 회사는 최근 FDA와의 D형 미팅에서 성공적인 결과를 얻어 505(b)(2) 규제 연결 전략을 확인했습니다. Adial의 최근 분석은 선정된 목표 환자군과 AD04가 AUD 및 관련 질환 치료에 효과적일 가능성에 대한 신뢰를 강화했습니다.
Adial Pharmaceuticals (NASDAQ : ADIL) a obtenu une réunion de fin de phase 2 avec la FDA, prévue pour le 25 juillet 2025. Cette réunion vise à discuter du plan de développement clinique de l'entreprise et à obtenir des conseils sur le design adaptatif d'enrichissement de la phase 3 pour AD04, leur principal médicament en investigation pour le trouble lié à l'usage d'alcool (AUD).
AD04 est un antagoniste du récepteur de la sérotonine-3 ciblé génétiquement, conçu pour traiter l'AUD chez les patients consommateurs excessifs d'alcool qui boivent moins de 8 verres par jour de consommation. L'entreprise a récemment obtenu des résultats positifs lors de leur réunion de type D avec la FDA, confirmant leur stratégie réglementaire 505(b)(2). Les analyses récentes d'Adial ont renforcé leur confiance dans la population cible sélectionnée et le potentiel d'efficacité d'AD04 dans le traitement de l'AUD et des affections associées.
Adial Pharmaceuticals (NASDAQ: ADIL) hat ein End-of-Phase-2-Meeting mit der FDA gesichert, das für den 25. Juli 2025 angesetzt ist. Ziel des Treffens ist es, den klinischen Entwicklungsplan des Unternehmens zu besprechen und eine Beratung zum adaptiven Enrichment-Design der Phase 3 für AD04, ihrem führenden Prüfpräparat für Alkoholgebrauchsstörung (AUD), einzuholen.
AD04 ist ein genetisch gezielter Serotonin-3-Rezeptor-Antagonist, der zur Behandlung von AUD bei stark trinkenden Patienten entwickelt wurde, die weniger als 8 Getränke pro Trinktag konsumieren. Das Unternehmen erzielte kürzlich erfolgreiche Ergebnisse in ihrem Type-D-Meeting mit der FDA und bestätigte damit ihre 505(b)(2)-Regulierungsstrategie. Die jüngsten Analysen von Adial haben das Vertrauen in die ausgewählte Zielpatientenpopulation und die potenzielle Wirksamkeit von AD04 bei der Behandlung von AUD und damit verbundenen Erkrankungen gestärkt.
- FDA granted the End of Phase 2 meeting request, showing regulatory progress
- Successful Type D Meeting confirming 505(b)(2) regulatory bridging strategy
- Strong progress in Phase 3 trial design development
- None.
Meeting to Take Place on July 25, 2025
Meeting’s Purpose is To Discuss Upcoming Clinical Development Plan and Protocol Designs
GLEN ALLEN, Va., May 08, 2025 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) (“Adial” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today announced that the FDA has granted Adial’s request for an End of Phase 2 meeting to discuss Adial’s proposed clinical development plan and seek FDA guidance on the Phase 3 adaptive with enrichment design of the upcoming clinical trial for AD04. The meeting will take place on July 25, 2025. AD04 is the Company’s lead investigational genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients (defined as < 8 drinks/drinking day).
Cary Claiborne, President and Chief Executive Officer of Adial, commented, “We recently announced the successful results of our Type D Meeting with FDA confirming Adial’s 505(b)(2) regulatory bridging strategy. Concurrently, we have made strong progress in developing the design of our Phase 3 trial and look forward to aligning with the FDA on key requirements to move AD04 forward. Our recent analyses have reinforced the selection of our target patient population and continue to support AD04’s potential to effectively treat AUD and related conditions. We remain confident in the path ahead and look forward to sharing a comprehensive update following our FDA meeting in July.”
About Adial Pharmaceuticals, Inc.
Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of treatments for addictions and related disorders. The Company’s lead investigational new drug product, AD04, is a genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients and was recently investigated in the Company’s ONWARD™ pivotal Phase 3 clinical trial for the potential treatment of AUD in subjects with certain target genotypes identified using the Company’s companion diagnostic genetic test. ONWARD showed promising results in reducing drinking in heavy drinking patients, and no overt safety or tolerability concerns. AD04 is also believed to have the potential to treat other addictive disorders such as Opioid Use Disorder, gambling, and obesity. Additional information is available at www.adial.com.
Forward-Looking Statements
This communication contains certain “forward-looking statements” within the meaning of the U.S. federal securities laws. Such statements are based upon various facts and derived utilizing numerous important assumptions and are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Statements preceded by, followed by or that otherwise include the words “believes,” “expects,” “anticipates,” “intends,” “projects,” “estimates,” “plans” and similar expressions or future or conditional verbs such as “will,” “should,” “would,” “may” and “could” are generally forward-looking in nature and not historical facts, although not all forward-looking statements include the foregoing. The forward-looking statements include statements regarding aligning with the FDA on key requirements to move AD04 forward, AD04’s potential to effectively treat AUD and related conditions, sharing a comprehensive update following the FDA meeting in July and the potential of AD04 to treat other addictive disorders such as Opioid Use Disorder, gambling, and obesity. Any forward-looking statements included herein reflect our current views, and they involve certain risks and uncertainties, including, among others, our ability to obtain feedback on the overall design of our Phase 3 program from the FDA , our ability to pursue our regulatory strategy, our ability to advance ongoing partnering discussions, our ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, our ability to develop strategic partnership opportunities and maintain collaborations, our ability to obtain or maintain the capital or grants necessary to fund our research and development activities, our ability to complete clinical trials on time and achieve desired results and benefits as expected, regulatory limitations relating to our ability to promote or commercialize our product candidates for specific indications, acceptance of our product candidates in the marketplace and the successful development, marketing or sale of our products, our ability to maintain our license agreements, the continued maintenance and growth of our patent estate and our ability to retain our key employees or maintain our Nasdaq listing. These risks should not be construed as exhaustive and should be read together with the other cautionary statement included in our Annual Report on Form 10-K for the year ended December 31, 2024, subsequent Quarterly Reports on Form 10-Q and current reports on Form 8-K filed with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was initially made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise, unless required by law.
Contact:
Crescendo Communications, LLC
David Waldman / Alexandra Schilt
Tel: 212-671-1020
Email: adil@crescendo-ir.com
FAQ
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