Adial Pharmaceuticals Receives Positive Response from FDA Meeting Regarding Proposed In Vitro Bridging Strategy for AD04
Adial Pharmaceuticals (NASDAQ: ADIL) has received positive feedback from the FDA regarding its proposed in vitro bridging strategy for AD04, a potential addiction treatment. The FDA's response confirms the company's 505(b)(2) regulatory pathway approach, which combines results from the AD04-103 relative bioavailability food-effect study with in vitro dissolution data.
The FDA's agreement with Adial's bridging strategy marks a significant regulatory milestone, though final approval will depend on the complete New Drug Application (NDA) review. Following this confirmation, Adial is moving forward with manufacturing clinical supply materials for its planned Phase 3 clinical program in 2025.
Adial Pharmaceuticals (NASDAQ: ADIL) ha ricevuto un feedback positivo dalla FDA riguardo alla sua proposta di strategia di bridging in vitro per AD04, un potenziale trattamento per la dipendenza. La risposta della FDA conferma l'approccio regolatorio 505(b)(2) dell'azienda, che combina i risultati dello studio sulla bioavailability relativa AD04-103 con i dati di dissoluzione in vitro.
L'accordo della FDA con la strategia di bridging di Adial segna un'importante pietra miliare regolatoria, anche se l'approvazione finale dipenderà dalla revisione completa della Nuova Domanda di Farmaco (NDA). Dopo questa conferma, Adial sta procedendo con la produzione di materiali per la fornitura clinica per il suo pianificato programma clinico di Fase 3 nel 2025.
Adial Pharmaceuticals (NASDAQ: ADIL) ha recibido comentarios positivos de la FDA sobre su propuesta de estrategia de puenteo in vitro para AD04, un posible tratamiento para la adicción. La respuesta de la FDA confirma el enfoque regulatorio 505(b)(2) de la compañía, que combina los resultados del estudio de biodisponibilidad relativa AD04-103 con datos de disolución in vitro.
El acuerdo de la FDA con la estrategia de puenteo de Adial marca un hito regulatorio significativo, aunque la aprobación final dependerá de la revisión completa de la Nueva Solicitud de Medicamento (NDA). Tras esta confirmación, Adial avanza en la fabricación de materiales de suministro clínico para su programa clínico de Fase 3 previsto para 2025.
아디알 제약 (NASDAQ: ADIL)은 잠재적인 중독 치료제인 AD04에 대한 제안된 인 비트로 브리징 전략에 대해 FDA로부터 긍정적인 피드백을 받았습니다. FDA의 응답은 AD04-103 상대 생체이용률 식이효과 연구 결과와 인 비트로 용해 데이터의 조합을 포함하는 회사의 505(b)(2) 규제 경로 접근 방식을 확인합니다.
FDA가 아디알의 브리징 전략에 동의한 것은 중요한 규제 이정표를 의미하지만, 최종 승인은 완전한 신약 신청(NDA) 검토에 따라 달라질 것입니다. 이 확인 이후, 아디알은 2025년 계획된 3상 임상 프로그램을 위한 임상 공급 자재 제조를 진행하고 있습니다.
Adial Pharmaceuticals (NASDAQ: ADIL) a reçu des retours positifs de la FDA concernant sa stratégie de pontage in vitro proposée pour AD04, un traitement potentiel de la dépendance. La réponse de la FDA confirme l'approche réglementaire 505(b)(2) de l'entreprise, qui combine les résultats de l'étude de biodisponibilité relative AD04-103 avec des données de dissolution in vitro.
L'accord de la FDA avec la stratégie de pontage d'Adial marque une étape réglementaire significative, bien que l'approbation finale dépendra de l'examen complet de la Demande de Nouveau Médicament (NDA). Suite à cette confirmation, Adial avance dans la fabrication de matériaux de fourniture clinique pour son programme clinique de Phase 3 prévu en 2025.
Adial Pharmaceuticals (NASDAQ: ADIL) hat positives Feedback von der FDA zu seiner vorgeschlagenen in-vitro-Bridging-Strategie für AD04, eine potenzielle Behandlung für Sucht, erhalten. Die Antwort der FDA bestätigt den regulatorischen Ansatz 505(b)(2) des Unternehmens, der die Ergebnisse der AD04-103-Studie zur relativen Bioverfügbarkeit mit in-vitro-Lösungsdaten kombiniert.
Die Zustimmung der FDA zur Bridging-Strategie von Adial stellt einen bedeutenden regulatorischen Meilenstein dar, obwohl die endgültige Genehmigung von der vollständigen Überprüfung des Neuen Arzneimittelantrags (NDA) abhängt. Nach dieser Bestätigung schreitet Adial mit der Herstellung klinischer Versorgungsmaterialien für sein geplantes klinisches Programm der Phase 3 im Jahr 2025 voran.
- FDA approval of bridging strategy enables Phase 3 trial progression
- Regulatory pathway confirmation reduces development risk
- Manufacturing of clinical supplies initiated for 2025 trials
- Final approval still dependent on complete NDA review
- Phase 3 trials not starting until 2025
Insights
Adial Pharmaceuticals has secured a critical regulatory milestone with the FDA's positive response to their proposed in vitro bridging strategy for AD04, their candidate treatment for addiction disorders. This development significantly de-risks their regulatory pathway and advances their timeline toward Phase 3 trials planned for 2025.
The FDA's agreement with Adial's 505(b)(2) regulatory strategy is particularly meaningful for a micro-cap company with a market capitalization of just
The in vitro bridging strategy essentially allows Adial to demonstrate that their commercial formulation is equivalent to the reference product through laboratory testing rather than conducting additional clinical trials. This represents both time and cost efficiency, important factors for a company with resources. The strategy leverages their AD04-103 study (a relative bioavailability food-effect study) alongside dissolution data showing equivalence between formulations.
With this regulatory hurdle cleared, Adial faces two critical challenges:
- Financing the Phase 3 program: With current market cap significantly below the typical cost of Phase 3 trials, Adial will likely need to secure additional funding through partnerships, grants, or equity raises, which may result in dilution for current shareholders.
- Execution risk: While the regulatory path is clearer, successful execution of the Phase 3 program remains challenging, particularly for addiction treatments which often face complex endpoint requirements.
For investors, this news represents a meaningful reduction in regulatory uncertainty, but the company's micro-cap status and the capital-intensive nature of late-stage clinical development warrant caution. The positive FDA feedback suggests the company's regulatory strategy is sound, but funding concerns and clinical execution risks remain significant considerations in evaluating Adial's prospects.
FDA feedback confirms Adial’s proposed in vitro bridging strategy to the Phase 3 formulation to fulfill the bridging requirement for the 505(b)(2) regulatory registration pathway for approval
Adial moves forward with manufacturing of clinical supplies for upcoming Phase 3 clinical program in 2025
GLEN ALLEN, Va., Feb. 25, 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 a positive response from the U.S. Food and Drug Administration (FDA) regarding its proposed in vitro bridging strategy for AD04.
The FDA’s feedback follows Adial’s submission on November 19, 2024, in which the Company sought the Agency’s guidance on the alignment of its AD04 formulation strategy and bridging approach. This step is crucial as it ensures compliance with the 505(b)(2) regulatory approval pathway following the completion of the AD04-103 study, a pivotal clinical trial designed to support the drug’s development. The Company also aimed to secure confirmation from the FDA that its proposed data package would meet the necessary bridging requirements and allow for the progression of AD04 into Phase 3 clinical trials.
In response, the FDA agreed with Adial’s proposed 505(b)(2) bridging strategy, which involves leveraging the results from AD04-103—a relative bioavailability food-effect study—along with in vitro dissolution data demonstrating equivalence between the reference product and the planned commercial formulation of AD04. While the final determination will depend on a comprehensive review of the complete New Drug Application (NDA), the FDA’s agreement signals a significant regulatory milestone for Adial.
With this regulatory confirmation in place, Adial is proceeding with the manufacturing of clinical supply materials in preparation for its upcoming Phase 3 clinical program in 2025. The Company remains committed to executing its development plan and working closely with regulatory authorities to bring AD04 to market as a potential breakthrough therapy for addiction.
“This milestone is an essential step forward in our efforts to advance AD04 into Phase 3 clinical development and, ultimately, toward regulatory approval,” stated Cary Claiborne, CEO of Adial Pharmaceuticals. “The FDA’s confirmation of our proposed in vitro bridging strategy brings us closer to achieving our goal of delivering a new treatment option for patients struggling with addiction.”
About Adial Pharmaceuticals, Inc.
Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of therapies for the treatment and prevention of addiction 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 proprietary companion diagnostic genetic test. ONWARD showed promising results in reducing heavy 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.
If you are interested in exploring partnership opportunities with Adial, we invite you to reach out to us (BD@adialpharma.com) to discuss how our joint efforts can bring about positive change to the millions of patients who are struggling with addiction.
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 the Company’s proposed 505(b)(2) bridging strategy, proceeding with the manufacturing of clinical supply materials in preparation for the Company’s upcoming Phase 3 clinical program in 2025, executing the Company’s development plan and working closely with regulatory authorities to bring AD04 to market as a potential breakthrough therapy for addiction, advancing AD04 into Phase 3 clinical development and, ultimately, toward regulatory approval, achieving the goal of delivering a new treatment option for patients struggling with addiction 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 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, 2023, 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
What is the significance of FDA's positive response to ADIL's bridging strategy?
What is ADIL's AD04-103 study and how does it relate to the bridging strategy?
When will ADIL begin Phase 3 clinical trials for AD04?
What therapeutic area is ADIL's AD04 targeting?
