Adial Pharmaceuticals Announces Positive Clinical Study Results from the AD04-103 Pharmacokinetics Study of AD04 for the Treatment of Alcohol Use Disorder
Adial Pharmaceuticals (NASDAQ: ADIL) has announced positive results from its AD04-103 pharmacokinetics study for AD04, a drug candidate being developed to treat Alcohol Use Disorder (AUD). The study, involving 30 healthy volunteers across two cohorts, demonstrated predictable bioavailability and dose proportionality in pharmacokinetic exposure.
The study confirmed that ondansetron pharmacokinetic exposure increased proportionally between AD04 0.33 mg tablets and marketed ondansetron 4 mg tablets, with no food effect on administration. These results support Adial's plans to pursue FDA approval under the 505(b)(2) regulatory pathway.
The company has submitted the results to the FDA and plans an End-of-Phase 2 meeting in the first half of the year to discuss the Phase 3 program design. The successful completion of this bridging study is expected to facilitate ongoing partnership discussions.
Adial Pharmaceuticals (NASDAQ: ADIL) ha annunciato risultati positivi dal suo studio di farmacocinetica AD04-103 per AD04, un candidato farmaco in fase di sviluppo per trattare il Disturbo da Uso di Alcol (AUD). Lo studio, che ha coinvolto 30 volontari sani suddivisi in due coorti, ha dimostrato una biodisponibilità prevedibile e una proporzionalità delle dosi nell'esposizione farmacocinetica.
Lo studio ha confermato che l'esposizione farmacocinetica all'ondansetron aumentava proporzionalmente tra compresse di AD04 da 0,33 mg e compresse di ondansetron da 4 mg già commercializzate, senza effetto del cibo durante l'assunzione. Questi risultati supportano i piani di Adial per perseguire l'approvazione da parte della FDA secondo il percorso normativo 505(b)(2).
L’azienda ha presentato i risultati alla FDA e prevede un incontro di Fine Fase 2 nella prima metà dell’anno per discutere il design del programma di Fase 3. Il completamento con successo di questo studio di collegamento dovrebbe facilitare le discussioni per eventuali partnership in corso.
Adial Pharmaceuticals (NASDAQ: ADIL) ha anunciado resultados positivos de su estudio de farmacocinética AD04-103 para AD04, un candidato a fármaco en desarrollo para tratar el Trastorno por Consumo de Alcohol (AUD). El estudio, que involucró a 30 voluntarios sanos distribuidos en dos cohortes, demostró una biodisponibilidad predecible y proporcionalidad de dosis en la exposición farmacocinética.
El estudio confirmó que la exposición farmacocinética al ondansetron aumentó proporcionalmente entre las tabletas de AD04 de 0.33 mg y las tabletas de ondansetron de 4 mg comercializadas, sin efecto de los alimentos en la administración. Estos resultados respaldan los planes de Adial para buscar la aprobación de la FDA a través de la vía regulatoria 505(b)(2).
La empresa ha enviado los resultados a la FDA y planea una reunión de Fin de Fase 2 en la primera mitad del año para discutir el diseño del programa de Fase 3. Se espera que la finalización exitosa de este estudio puente facilite las discusiones en curso sobre asociaciones.
Adial Pharmaceuticals (NASDAQ: ADIL)는 알코올 사용 장애(AUD) 치료를 위해 개발 중인 약물 후보 AD04에 대한 AD04-103 약리학적 연구의 긍정적인 결과를 발표했습니다. 이 연구는 30명의 건강한 자원자를 두 개의 그룹으로 나누어 진행되었으며, 약리학적 노출에서 예측 가능한 생체 이용률과 용량 비례성을 입증했습니다.
연구 결과, AD04 0.33 mg 정제와 시판 중인 ondansetron 4 mg 정제 간의 약리학적 노출이 비례적으로 증가하며, 복용 시 음식의 영향이 없음을 확인했습니다. 이러한 결과는 Adial이 505(b)(2) 규제 경로에 따라 FDA 승인을 추구하는 계획을 지원합니다.
회사는 결과를 FDA에 제출했으며, 올해 상반기 중에 3상 프로그램 설계를 논의하기 위한 제2단계 종료 회의를 계획하고 있습니다. 이 다리 연구의 성공적인 완료는 진행 중인 파트너십 논의를 용이하게 할 것으로 기대됩니다.
Adial Pharmaceuticals (NASDAQ: ADIL) a annoncé des résultats positifs de son étude de pharmacocinétique AD04-103 pour AD04, un candidat médicament en développement pour traiter le Trouble de l'Usage de l'Alcool (AUD). L'étude, impliquant 30 volontaires en bonne santé répartis en deux cohortes, a démontré une biodisponibilité prévisible et une proportionnalité des doses dans l'exposition pharmacocinétique.
L'étude a confirmé que l'exposition pharmacocinétique à l'ondansétron augmentait proportionnellement entre les comprimés de AD04 de 0,33 mg et les comprimés d'ondansétron de 4 mg commercialisés, sans effet des aliments lors de l'administration. Ces résultats soutiennent les plans d'Adial pour demander l'approbation de la FDA sous le chemin réglementaire 505(b)(2).
L'entreprise a soumis les résultats à la FDA et prévoit une réunion de Fin de Phase 2 dans la première moitié de l'année pour discuter de la conception du programme de Phase 3. L'achèvement réussi de cette étude de liaison devrait faciliter les discussions de partenariat en cours.
Adial Pharmaceuticals (NASDAQ: ADIL) hat positive Ergebnisse aus seiner AD04-103-Pharmakokinetikstudie für AD04 bekannt gegeben, ein Arzneimittelkandidat, der zur Behandlung von Alkoholgebrauchsstörungen (AUD) entwickelt wird. Die Studie, in der 30 gesunde Freiwillige in zwei Kohorten untersucht wurden, zeigte eine vorhersehbare Bioverfügbarkeit und Dosisproportionalität in der pharmakokinetischen Exposition.
Die Studie bestätigte, dass die pharmakokinetische Exposition gegenüber Ondansetron proportional zwischen AD04 0,33 mg Tabletten und den auf dem Markt befindlichen Ondansetron 4 mg Tabletten anstieg, ohne dass ein Einfluss der Nahrung bei der Verabreichung festgestellt wurde. Diese Ergebnisse unterstützen die Pläne von Adial, die FDA-Zulassung über den regulatorischen Weg 505(b)(2) zu verfolgen.
Das Unternehmen hat die Ergebnisse an die FDA übermittelt und plant in der ersten Jahreshälfte ein Treffen zum Ende der Phase 2, um das Design des Phase-3-Programms zu besprechen. Der erfolgreiche Abschluss dieser Brückenstudie wird voraussichtlich die laufenden Partnerschaftsgespräche erleichtern.
- Successful completion of pharmacokinetics study supporting 505(b)(2) regulatory pathway
- Demonstrated predictable bioavailability and dose proportionality
- No food effect on drug administration, increasing flexibility of use
- Safety and tolerability profile consistent with established ondansetron use
- None.
Insights
The completion of Adial's pharmacokinetics study for AD04 represents a significant milestone in their clinical development program. The study's positive results are particularly meaningful for three key reasons:
- The demonstrated dose proportionality and predictable bioavailability significantly de-risk the development program, as these characteristics are important for FDA approval
- The confirmation that AD04 can be taken with or without food removes a potential barrier to patient compliance and marketability
- The successful bridging to ondansetron through the 505(b)(2) pathway could substantially reduce development costs and time to market
The 505(b)(2) regulatory strategy is particularly clever as it leverages ondansetron's established safety profile while targeting a novel indication. This approach typically reduces the required number of studies, potentially saving tens of millions in development costs and years of clinical trials.
For investors, these results carry three significant implications:
- The clear path to the End-of-Phase 2 meeting in H1 2024 provides a near-term catalyst
- The positive PK data strengthens Adial's position in partnership discussions, potentially accelerating deal opportunities
- The micro-dosing approach could provide a competitive advantage in the $35 billion global addiction treatment market, particularly for AUD where patient compliance is crucial
The successful completion of this pharmacokinetics study represents a pivotal inflection point for Adial's business model. The data package now positions the company for three critical business developments:
- Enhanced partnership potential, as the de-risked PK profile and clear regulatory pathway make AD04 more attractive to potential pharmaceutical partners
- Streamlined development costs through the 505(b)(2) pathway, which typically requires 50-60% less capital than traditional drug development
- Accelerated time-to-market potential, important for a small-cap biotech with cash resources
The biomarker-driven approach targeting specific 5-HT3 genetic variants creates a compelling precision medicine narrative that could command premium pricing. This positions AD04 as a potential first-in-class targeted therapy for AUD, a significant advantage in a market currently dominated by generic treatments.
The micro-dosing strategy could provide both clinical and commercial advantages: lower manufacturing costs, potentially better safety profile and improved patient compliance - all critical factors for success in the addiction treatment market.
Completion enables the End-of-Phase 2 (EOP2) interaction with the FDA on the design of the Phase 3 program and is expected to facilitate ongoing partnership discussions
Adial’s formulation exhibited predictable bioavailability relative to the reference standard; near-micro doses exhibited dose proportionality in pharmacokinetic exposure, and no food effect
Safety and tolerability consistent with ondansetron’s extensive human use experience
GLEN ALLEN, Va., Jan. 29, 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, announced the completion of a pharmacokinetics (PK) study of AD04, and has made a regulatory submission of the results to the FDA. AD04 is the Company's investigational drug candidate, a selective serotonin-3 receptor (5-HT3) antagonist being developed for the treatment of Alcohol Use Disorder (AUD) in patients with a 5-HT3 genomic biomarker. These study results support the near micro-dosing regimen planned for use in the upcoming registration trials for AD04 and conform with the FDA’s bridging requirements for a 505(b)(2) registration pathway.
The purpose of the study, AD04-103, was to evaluate the PK, bioavailability, and food effect of AD04 near-micro doses relative to marketed ondansetron in healthy volunteers (HVs). The study was conducted in two phases and enrolled a total of 30 HVs in two cohorts.
- Cohort 1 (n=6): A randomized, open-label, two-sequence, two-period crossover study evaluating the PK variability of ondansetron in AD04 0.33 mg and 0.99 mg doses.
- Cohort 2 (n=24): A randomized, open-label, six-sequence, four-period crossover study evaluating the relative bioavailability of AD04 0.33 mg tablets compared to marketed ondansetron 4 mg tablets, the dose proportionality of ondansetron PK between AD04 0.33 mg and 0.99 mg doses, and the food effect on the bioavailability of ondansetron administered as AD04 0.33 mg tablets.
The results of the study confirmed that ondansetron pharmacokinetic exposure increased proportionally across a three–fold AD04 dose range, between AD04 0.33 mg tablets and the marketed ondansetron 4 mg tablets. Additionally, the study demonstrated that AD04 can be taken with or without food.
Cary Claiborne, President and Chief Executive Officer of Adial commented, “Successful completion of this bridging study supports our plans to pursue FDA approval of AD04 under the 505(b)(2) regulatory pathway. We have engaged with the FDA on the results of this PK bridging study and will incorporate their feedback as we prepare for our End-of-Phase 2 meeting, targeted to take place in the first half of this year. We are excited to achieve this important milestone on the path toward regulatory approval.”
About AD04
AD04 (0.33 mg ondansetron taken orally twice daily) acts upon the 5HT3 pathway and is thought to reduce alcohol craving. This mode of action is distinct from, but complimentary to, the currently approved therapies for AUD. Adial's prior clinical studies have indicated that patients with mutations in the 5HT3 receptor may experience substantial and clinically meaningful reductions in alcohol consumption. The specific mutations that appear to respond to AD04 are single nucleotide polymorphisms (SNPs) on rs1150226-AG ("AG") or rs1176713-GG ("GG") genotypes in the gene that encodes the 5-HT3A receptor subunit. These genes are thought to affect the binding of AD04 to the 5HT3 receptor and its function. Furthermore, in both previous clinical trials, AD04 had similar adverse events to placebo.
Adial has already developed a companion diagnostic test (CDx) to select patients with the specific genomic biomarker that may benefit from AD04. It was successfully used in a large scale randomized controlled trial (RCT), the ONWARD study, and will be advanced in future clinical studies, to support FDA approval and commercial availability at the time of AD04's launch.
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 selective serotonin-3 receptor antagonist. AD04 is being developed for the treatment of Alcohol Use Disorder (AUD) in patients with a 5-HT3 genomic biomarker. AD04 was recently investigated in a large scale RCT, the ONWARD™ study for the potential treatment of AUD in subjects with certain target genotypes. 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 completion of the pharmacokinetics study of AD04 for the Treatment of Alcohol Use Disorder enabling the end-of-Phase 2 (EOP2) interaction with the FDA on the design of the Phase 3 program and facilitating ongoing partnership discussions, study results supporting the near micro-dosing regimen planned for use in the upcoming registration trials for AD04, successful completion of this bridging study supporting the Company’s plans to pursue FDA approval of AD04 under the 505(b)(2) regulatory pathway, incorporating FDA feedback on the results of the PK bridging study, preparing for an End-of-Phase 2 meeting in the first half of this year, advancing the Company’s companion diagnostic test (CDx) in future clinical studies to support FDA approval, commercial availability at the time of AD04's launch, 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
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