Adial Pharmaceuticals Completes Successful EOP2 FDA Meeting
Adial Pharmaceuticals (NASDAQ:ADIL) has successfully completed its End of Phase 2 meeting with the FDA regarding AD04, its lead investigational drug for Alcohol Use Disorder (AUD). The FDA provided crucial input for the Phase 3 adaptive design clinical trial, focusing on treating AUD in individuals with heavy drinking and select genotypes, particularly the AG+ genotype.
The meeting aligned key elements including population selection, endpoints, inclusion/exclusion criteria, and dose regime. The company utilized advanced statistical analytics and simulation modeling to refine the trial design. CEO Cary Claiborne emphasized that this regulatory clarity is expected to enhance ongoing partnership discussions.
Adial Pharmaceuticals (NASDAQ:ADIL) ha completato con successo il proprio incontro di fine Fase 2 con la FDA riguardo AD04, il suo principale farmaco sperimentale per il Disturbo da Uso di Alcol (AUD). La FDA ha fornito indicazioni fondamentali per il disegno adattativo dello studio clinico di Fase 3, concentrandosi sul trattamento dell'AUD in individui con consumo eccessivo di alcol e specifici genotipi, in particolare il genotipo AG+.
Durante l'incontro sono stati concordati gli elementi chiave come la selezione della popolazione, gli endpoint, i criteri di inclusione/esclusione e il regime posologico. L'azienda ha utilizzato analisi statistiche avanzate e modelli di simulazione per perfezionare il disegno dello studio. Il CEO Cary Claiborne ha sottolineato che questa chiarezza regolatoria dovrebbe favorire le discussioni in corso con i partner.
Adial Pharmaceuticals (NASDAQ:ADIL) ha completado con éxito su reunión de fin de Fase 2 con la FDA respecto a AD04, su principal fármaco en investigación para el Trastorno por Consumo de Alcohol (AUD). La FDA proporcionó aportes clave para el diseño adaptativo del ensayo clínico de Fase 3, enfocándose en tratar el AUD en personas con consumo excesivo de alcohol y genotipos específicos, especialmente el genotipo AG+.
En la reunión se alinearon elementos clave como la selección de la población, los puntos finales, los criterios de inclusión/exclusión y el régimen de dosis. La compañía utilizó análisis estadísticos avanzados y modelos de simulación para perfeccionar el diseño del ensayo. El CEO Cary Claiborne destacó que esta claridad regulatoria se espera que mejore las discusiones en curso con socios.
Adial Pharmaceuticals (NASDAQ:ADIL)는 FDA와의 2상 종료 미팅을 성공적으로 마쳤으며, 이는 알코올 사용 장애(AUD) 치료를 위한 주력 신약 AD04와 관련된 것입니다. FDA는 과음 및 특정 유전자형, 특히 AG+ 유전자형을 가진 AUD 환자를 대상으로 하는 3상 적응형 임상시험 설계에 중요한 의견을 제공했습니다.
미팅에서는 대상자 선정, 평가 지표, 포함/제외 기준, 투약 체계 등 주요 요소들이 조율되었습니다. 회사는 고급 통계 분석과 시뮬레이션 모델링을 활용해 시험 설계를 개선했습니다. CEO 캐리 클레이본은 이번 규제 명확성이 진행 중인 파트너십 논의를 촉진할 것으로 기대한다고 강조했습니다.
Adial Pharmaceuticals (NASDAQ:ADIL) a réussi sa réunion de fin de phase 2 avec la FDA concernant AD04, son principal médicament expérimental pour le trouble lié à l'usage d'alcool (AUD). La FDA a fourni des orientations essentielles pour la conception adaptative de l'essai clinique de phase 3, en se concentrant sur le traitement de l'AUD chez les personnes ayant une consommation excessive d'alcool et certains génotypes, en particulier le génotype AG+.
La réunion a permis d'aligner les éléments clés tels que la sélection de la population, les critères d'évaluation, les critères d'inclusion/exclusion et le régime posologique. L'entreprise a utilisé des analyses statistiques avancées et des modélisations par simulation pour affiner la conception de l'essai. Le PDG Cary Claiborne a souligné que cette clarté réglementaire devrait favoriser les discussions en cours avec les partenaires.
Adial Pharmaceuticals (NASDAQ:ADIL) hat erfolgreich sein End-of-Phase-2-Meeting mit der FDA bezüglich AD04, seines führenden Prüfpräparats zur Behandlung der Alkoholgebrauchsstörung (AUD), abgeschlossen. Die FDA gab wichtige Hinweise für das adaptive Design der Phase-3-Studie, die sich auf die Behandlung von AUD bei Personen mit starkem Alkoholkonsum und bestimmten Genotypen, insbesondere dem AG+-Genotyp, konzentriert.
Im Meeting wurden zentrale Elemente wie die Auswahl der Population, Endpunkte, Ein- und Ausschlusskriterien sowie Dosierungsschemata abgestimmt. Das Unternehmen nutzte fortschrittliche statistische Analysen und Simulationen, um das Studiendesign zu verfeinern. CEO Cary Claiborne betonte, dass diese regulatorische Klarheit die laufenden Partnerschaftsgespräche voraussichtlich fördern wird.
- None.
- Phase 3 trials yet to commence
- No partnership agreements currently in place
Insights
Adial's successful FDA meeting derisks AD04's path to Phase 3 for alcohol use disorder, enhancing partnership opportunities.
The successful completion of Adial's End-of-Phase 2 FDA meeting represents a significant regulatory milestone for the company's lead candidate AD04. This serotonin-3 receptor antagonist is being developed for Alcohol Use Disorder (AUD) with a precision medicine approach targeting patients with specific genotypes, particularly the AG+ genotype.
The FDA meeting has provided crucial regulatory clarity on the Phase 3 adaptive design trial, including population selection, endpoints, inclusion/exclusion criteria, and dosing regimen. Most importantly, the FDA has affirmed the company's biomarker-driven approach, which substantially derisks the upcoming pivotal program.
This regulatory advancement is particularly valuable for a small biotech like Adial (
The company's mention of "advanced statistical analytics and simulation modeling" to refine trial design suggests they've conducted thorough analyses of their Phase 2 data to identify the patient population most likely to respond to AD04. This targeted approach should increase their probability of success in Phase 3.
For a company developing a treatment for AUD—a condition with significant unmet medical need and limited effective pharmacotherapies—this regulatory progress positions Adial to potentially capture value in an underserved market with high commercial potential.
Meeting Completion Marks Major Step Toward Phase 3 AD04 Trial Launch
Strategic Partnership Discussions Expected Following the Positive FDA Meeting
GLEN ALLEN, Va., Aug. 06, 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 the completion of a successful End of Phase 2 meeting (EOP2M) with the Food and Drug Administration (FDA). The FDA has provided input into the AD04 Phase 3 adaptive design clinical trial and the overall clinical program.
Following the meeting, Adial is now prepared to advance AD04- its lead investigational drug and a serotonin-3 receptor antagonist- into its Phase 3 clinical development program for the treatment of Alcohol Use Disorder (AUD) in individuals with heavy drinking and select genotypes and, most importantly, the AG+ genotype.
The objective for the EOP2M was to align with the FDA on the design of the Phase 3 clinical development program for AD04. This included key elements of the planned adaptive study design elements, such as population, endpoints, inclusion/exclusion criteria, dose regime, and affirmation of the biomarker positive and biomarker negative groups.
Clarity and validation from the FDA on the clinical development path is expected to strengthen Adial’s position in discussions with potential partners, who typically view regulatory momentum as a key de-risking milestone in the decision-making process.
Cary Claiborne, President and Chief Executive Officer of Adial commented, “We are highly encouraged by the FDA’s feedback and progress made over the past several months, which included a thorough analysis of our historical data through advanced statistical analytics and simulation modeling. These efforts have been instrumental in refining the trial design to focus on the AUD population most likely to benefit from AD04 treatment. We look forward to advancing the clinical program for AD04 and are optimistic about achieving a successful outcome in the Phase 3 program. Importantly, we believe the productive FDA meeting will also enhance our ability to advance ongoing partnership discussions, as regulatory clarity is a key consideration for potential collaborators.”
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 conducting strategic partnership discussions following the positive FDA meeting, advancing AD04 into its Phase 3 clinical development program for the treatment of AUD in individuals with heavy drinking and select genotypes, including the AG+ genotype, clarity and validation from the FDA on the clinical development path strengthening Adial’s position in discussions with potential partners, refining the trial design to focus on the AUD population most likely to benefit from AD04 treatment, achieving a successful outcome in the Phase 3 program 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 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
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