Adial Pharmaceuticals Announces Positive Topline Results from the AD04-103 Pharmacokinetics Study of AD04 for the Treatment of Alcohol Use Disorder
Adial Pharmaceuticals (NASDAQ: ADIL) announced positive topline results from the AD04-103 Pharmacokinetics Study for their alcohol use disorder treatment. The study, involving 30 healthy adult volunteers, confirmed AD04's relative bioavailability to reference ondansetron, demonstrated dose-proportional increases in pharmacokinetic exposure, and showed no food effect. The study met FDA requirements for upcoming Phase 3 trials and will help optimize the study design. Results showed AD04 0.33mg delivered lower ondansetron exposure than the 4mg reference tablet, with proportional increases across a 3-fold dose range. The company plans to engage with FDA in Q4 2024 to discuss Phase 3 study program.
Adial Pharmaceuticals (NASDAQ: ADIL) ha annunciato risultati positivi dai dati preliminari dello Studio di Farmacocinetica AD04-103 per il loro trattamento del disturbo da uso di alcol. Lo studio, che ha coinvolto 30 volontari adulti sani, ha confermato la biodisponibilità relativa di AD04 rispetto all’ondansetron di riferimento, dimostrando aumenti proporzionali nella esposizione farmacocinetica e non ha mostrato effetti del cibo. Lo studio ha soddisfatto i requisiti della FDA per i futuri studi di Fase 3 e aiuterà ad ottimizzare il design dello studio. I risultati hanno mostrato che AD04 0.33mg ha fornito un’esposizione di ondansetron inferiore rispetto al tablet di riferimento da 4mg, con aumenti proporzionali su un intervallo di dosaggio triplo. L'azienda prevede di interagire con la FDA nel Q4 2024 per discutere il programma dello studio di Fase 3.
Adial Pharmaceuticals (NASDAQ: ADIL) anunció resultados positivos preliminares del Estudio de Farmacocinética AD04-103 para su tratamiento del trastorno por consumo de alcohol. El estudio, que involucró a 30 voluntarios adultos sanos, confirmó la biodisponibilidad relativa de AD04 en comparación con el ondansetron de referencia, demostró aumentos proporcionales en la exposición farmacocinética y no mostró efecto de los alimentos. El estudio cumplió con los requisitos de la FDA para los próximos ensayos de Fase 3 y ayudará a optimizar el diseño del estudio. Los resultados mostraron que AD04 0.33mg presentó menor exposición a ondansetron que la tableta de referencia de 4mg, con aumentos proporcionales a lo largo de un rango de dosis de 3 veces. La empresa planea comunicarse con la FDA en el Q4 de 2024 para discutir el programa del estudio de Fase 3.
Adial Pharmaceuticals (NASDAQ: ADIL)는 알코올 사용 장애 치료를 위한 AD04-103 약리학적 연구의 긍정적인 초기 결과를 발표했습니다. 30명의 건강한 성인 자원자를 포함한 이 연구는 AD04의 상대 생체이용률을 기준인 온단세트론과 비교해 확인하였으며, 약리학적 노출의 복용량 비례 증가를 보여주었고, 음식의 효과는 없음을 나타냈습니다. 이 연구는 향후 3상 시험을 위한 FDA의 요건을 충족하였으며 연구 설계를 최적화하는 데 도움이 될 것입니다. 결과에 따르면 AD04 0.33mg은 4mg 기준 태블릿보다 낮은 온단세트론 노출을 제공하였고, 3배 복용량 범위에서 비례적 증가를 보였습니다. 회사는 2024년 4분기에 FDA와 접촉하여 3상 연구 프로그램에 대해 논의할 계획입니다.
Adial Pharmaceuticals (NASDAQ: ADIL) a annoncé des résultats positifs préliminaires de l'Étude de Pharmacocinétique AD04-103 pour leur traitement du trouble lié à l'utilisation d'alcool. L'étude, impliquant 30 volontaires adultes en bonne santé, a confirmé la biodisponibilité relative de AD04 par rapport à l'ondansétron de référence, a démontré des augmentations proportionnelles de l'exposition pharmacocinétique et n'a montré aucun effet alimentaire. L'étude a satisfait aux exigences de la FDA pour les prochains essais de phase 3 et aidera à optimiser le design de l'étude. Les résultats ont montré que AD04 0.33mg avait une exposition à l'ondansétron inférieure à celle du comprimé référence de 4mg, avec des augmentations proportionnelles sur une plage de dosage 3 fois supérieure. L'entreprise prévoit de communiquer avec la FDA au quatrième trimestre 2024 pour discuter du programme de l'étude de phase 3.
Adial Pharmaceuticals (NASDAQ: ADIL) hat positive vorläufige Ergebnisse aus der AD04-103 Pharmakokinetik-Studie zur Behandlung von Alkoholmissbrauch bekannt gegeben. Die Studie, an der 30 gesunde erwachsene Freiwillige teilnahmen, bestätigte die relative Bioverfügbarkeit von AD04 im Vergleich zu Referenzondansetron, zeigte dosisproportionale Zunahmen der pharmakokinetischen Exposition und keinen Lebensmitteleffekt. Die Studie erfüllte die FDA-Anforderungen für bevorstehende Phase-3-Studien und wird helfen, das Studiendesign zu optimieren. Die Ergebnisse zeigten, dass AD04 0,33 mg eine geringere Ondansetron-Exposition als die 4 mg Referenztablette lieferte, mit proportionalen Anstiegen über einen 3-fachen Dosisbereich. Das Unternehmen plant, im vierten Quartal 2024 mit der FDA zu sprechen, um das Phase-3-Studienprogramm zu besprechen.
- Successfully completed FDA-required pharmacokinetics study for Phase 3 trial advancement
- Demonstrated positive dose proportionality and no food effect restrictions
- Study supports 505(b)(2) regulatory pathway application
- Maintained excellent safety and tolerability profile
- Lower ondansetron exposure compared to reference standard
Insights
The pharmacokinetics study results for AD04 represent a significant milestone in advancing this alcohol use disorder treatment. The study demonstrated three key findings: dose-proportional increases in drug exposure, confirmed relative bioavailability compared to standard ondansetron and no food effect on absorption. These results are particularly meaningful as they satisfy FDA requirements and provide important data for Phase 3 trial design.
The study's design was robust, involving 30 volunteers across two cohorts, evaluating multiple critical parameters including bioavailability and dose proportionality. The confirmation that AD04 can be taken with or without food enhances its practical clinical utility. The lower exposure compared to standard 4mg ondansetron tablets aligns with the targeted approach for AUD treatment, potentially offering a better safety profile while maintaining therapeutic efficacy.
This development significantly strengthens Adial's position for both regulatory advancement and partnership discussions. The successful completion of this FDA-required study removes a key hurdle before Phase 3 trials and enhances the company's 505(b)(2) regulatory pathway strategy, which typically requires less time and resources than traditional approval routes. The timing of the FDA meeting in Q4 2024 provides a near-term catalyst for the stock.
For a micro-cap company with a market cap of
Confirmed relative bioavailability to the reference standard, dose proportional increases in pharmacokinetic exposure, and no food effect
Marks final study needed for the upcoming FDA meeting for the Phase 3 study design and ongoing partnership discussions
Continued excellent safety and tolerability findings, consistent with extensive human use experience with ondansetron
GLEN ALLEN, Va., Nov. 14, 2024 (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 that it has completed a pharmacokinetics (PK) study of AD04, the Company's lead investigational genetically targeted, serotonin-3 receptor antagonist, and therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients (defined as less than 10 drinks/drinking day). This data will help the Company optimize study design elements needed for the upcoming Phase 3 clinical trial of AD04. Completion of this study also satisfied an FDA requirement for the upcoming Phase 3 clinical trials of AD04.
The study, a single-center, relative bioavailability, open label study, enrolled a total of 30 healthy adult volunteers in two cohorts. Cohort 1 (n=6) was a randomized, open-label, 2-sequence, 2-period crossover study to evaluate the PK variability of ondansetron from AD04 0.33 and 0.99mg. Cohort 2 (n=24) was a randomized, open-label, 6-sequence, 4-period crossover study to evaluate the relative bioavailability of the AD04 0.33mg tablet to a marketed ondansetron 4mg tablet, dose proportionality of ondansetron PK between AD04 0.33 and 0.99mg, and the effect of food on the bioavailability of ondansetron administered as the AD04 0.33mg tablet. The results of this study showed that, as a result of the lower dose, AD04 0.33mg delivered lower ondansetron PK exposure than the marketed reference standard ondansetron 4mg tablet; ondansetron pharmacokinetic exposure increased in proportion to dose across a 3–fold AD04 dose range; and AD04 can be taken in fed or fasted states.
Cary Claiborne, President and Chief Executive Officer of Adial commented, "Completion of this study achieves our goal to obtain the data we needed to design a more precise and informed Phase 3 trial protocol, including evaluating the optimal dosing regimen to maximize the efficacy and safety of AD04 in patients with AUD. Its completion is in accord with previous guidance provided by the FDA and is intended to enhance the likelihood of success in our upcoming Phase 3 trial. This relatively short and low-cost study was a key element of our strategy to advance ongoing partnership discussions. Additionally, the study will provide data necessary to support an application for approval of AD04 under a 505(b)(2) regulatory pathway with the FDA. We plan to engage with the FDA during Q4 2024 with the results of this pharmacokinetics study and obtain feedback which will assist with the AD04 Phase 3 study program. This meeting is an important next step to further advancing AD04 towards regulatory approval."
About AD04
AD04 (0.33mg 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. Post-hoc analyses of Adial's prior clinical studies have indicated that patients with mutations in the 5HT3 receptor 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, which further supports that it is likely to be extremely safe and tolerable. Adial has already developed a companion diagnostic test (CDx) to identify the specific genotypes that benefit from AD04. This test was used in its Phase 3 ONWARD study, will be used in future clinical studies, and will be commercially available 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 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 the pharmacokinetics study data helping the Company optimize study design elements needed for the upcoming Phase 3 clinical trial of AD04, designing a more precise and informed Phase 3 trial protocol, completion of the study providing the data needed to design a more precise and informed Phase 3 trial protocol, including evaluating the optimal dosing regimen to maximize the efficacy and safety of AD04 in patients with AUD, completion of the study enhancing the likelihood of success in the Company’s upcoming Phase 3 trial, advancing ongoing partnership discussions, the study providing data necessary to support an application for approval of AD04 under a 505(b)(2) regulatory pathway with the FDA, plans to engage with the FDA during Q4 2024 with the results of the pharmacokinetics study and obtain feedback which will assist with the AD04 Phase 3 study program, further advancing AD04 towards regulatory approval 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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