Adial Pharmaceuticals Announces Database Lock in Pharmacokinetics Study of AD04 for the Treatment of Alcohol Use Disorder
Adial Pharmaceuticals (NASDAQ: ADIL) has announced the database lock for its pharmacokinetics study of AD04, the company's lead investigational treatment for Alcohol Use Disorder (AUD) in heavy drinking patients. The study, which enrolled 30 healthy adult volunteers, compared the pharmacokinetic profile of AD04 at a 0.33 mg oral dose, with or without food, against a reference standard product.
Topline results are expected in the fourth quarter of 2024. The data has been transferred to independent statisticians for analysis, which will inform Adial's next FDA interaction and help shape the clinical strategy for the upcoming Phase 3 study. The company believes these results will strengthen its position for potential strategic collaborations and future clinical development of AD04.
Adial Pharmaceuticals (NASDAQ: ADIL) ha annunciato il blocco del database per il suo studio di farmacocinetica di AD04, il principale trattamento investigativo della società per il Disturbo da Uso di Alcool (AUD) in pazienti con forte alcoolismo. Lo studio, che ha arruolato 30 volontari adulti sani, ha confrontato il profilo farmacocinetico di AD04 a una dose orale di 0,33 mg, con o senza cibo, rispetto a un prodotto standard di riferimento.
I risultati preliminari sono attesi nel quarto trimestre del 2024. I dati sono stati trasferiti a statistici indipendenti per l'analisi, che informerà la prossima interazione di Adial con la FDA e contribuirà a definire la strategia clinica per il prossimo studio di Fase 3. L'azienda crede che questi risultati rafforzeranno la sua posizione per potenziali collaborazioni strategiche e lo sviluppo clinico futuro di AD04.
Adial Pharmaceuticals (NASDAQ: ADIL) ha anunciado el cierre de la base de datos para su estudio de farmacocinética de AD04, el tratamiento investigacional principal de la empresa para el Trastorno por Consumo de Alcohol (AUD) en pacientes con un alto consumo de alcohol. El estudio, que incluyó a 30 voluntarios adultos sanos, comparó el perfil farmacocinético de AD04 a una dosis oral de 0.33 mg, con o sin alimentos, frente a un producto estándar de referencia.
Se esperan resultados preliminares en el cuarto trimestre de 2024. Los datos se han transferido a estadísticos independientes para su análisis, lo que informará la próxima interacción de Adial con la FDA y ayudará a dar forma a la estrategia clínica para el próximo estudio de Fase 3. La empresa cree que estos resultados fortalecerán su posición para colaboraciones estratégicas potenciales y el desarrollo clínico futuro de AD04.
Adial Pharmaceuticals (NASDAQ: ADIL)가 중증 음주 환자의 알코올 사용 장애 (AUD)에 대한 주요 임상 시험 치료제인 AD04의 약리학적 연구 데이터 잠금을 발표했습니다. 이 연구에는 30명의 건강한 성인 자원자가 등록되었으며, AD04의 0.33 mg 경구 투여량을 음식의 유무에 따라 비교하였습니다.
결과는 2024년 4분기에 발표될 예정입니다. 데이터는 독립 통계 전문가에게 분석을 위해 전달되었으며, 이는 Adial의 다음 FDA와의 상호작용에 정보를 제공하고 향후 3상 연구를 위한 임상 전략을 형성하는 데 도움이 될 것입니다. 회사는 이러한 결과가 AD04의 잠재적인 전략적 협업 및 향후 임상 개발을 위한 위치를 강화할 것이라고 믿고 있습니다.
Adial Pharmaceuticals (NASDAQ: ADIL) a annoncé le verrouillage de la base de données pour son étude pharmacocinétique de AD04, le principal traitement investigational de la société pour le trouble de l'utilisation de l'alcool (AUD) chez les patients ayant une forte consommation d'alcool. L'étude a recruté 30 volontaires adultes en bonne santé et a comparé le profil pharmacocinétique de AD04 à une dose orale de 0,33 mg, avec ou sans nourriture, par rapport à un produit standard de référence.
Les résultats préliminaires sont attendus au quatrième trimestre 2024. Les données ont été transférées à des statisticiens indépendants pour analyse, ce qui informera la prochaine interaction d'Adial avec la FDA et aidera à façonner la stratégie clinique pour la prochaine étude de phase 3. L'entreprise pense que ces résultats renforceront sa position pour d'éventuelles collaborations stratégiques et le développement clinique futur de AD04.
Adial Pharmaceuticals (NASDAQ: ADIL) hat die Sperrung der Datenbank für seine pharmakokinetische Studie zu AD04, der führenden experimentellen Behandlung des Unternehmens für Alkoholkonsumstörung (AUD) bei stark trinkenden Patienten, bekannt gegeben. Die Studie umfasste 30 gesunde erwachsene Freiwillige und verglich das pharmakokinetische Profil von AD04 in einer oralen Dosis von 0,33 mg, mit oder ohne Nahrung, mit einem Referenzstandardprodukt.
Die ersten Ergebnisse werden im vierten Quartal 2024 erwartet. Die Daten wurden an unabhängige Statistiker zur Analyse übergeben, die Adials nächste Interaktion mit der FDA informieren und die klinische Strategie für die bevorstehende Phase-3-Studie mitgestalten werden. Das Unternehmen glaubt, dass diese Ergebnisse seine Position für potenzielle strategische Kooperationen und die zukünftige klinische Entwicklung von AD04 stärken werden.
- Database lock achieved for pharmacokinetics study of AD04
- Topline results expected in Q4 2024
- Study results to inform FDA interaction and Phase 3 study planning
- Potential for strengthening strategic collaborations
- None.
Insights
The database lock for Adial Pharmaceuticals' pharmacokinetics study of AD04 is a important milestone in the drug development process. This study, focusing on Alcohol Use Disorder (AUD) treatment, marks a significant step towards potential FDA approval. The 30-participant study examining bioavailability and dose proportionality will provide essential data on how the body processes AD04.
Key points to consider:
- The study's design, comparing 0.33 mg oral doses with and without food, will inform optimal administration guidelines.
- Results could significantly impact the Phase 3 study design, potentially streamlining the path to market.
- The genetically targeted approach of AD04 could represent a paradigm shift in AUD treatment, potentially offering more personalized and effective therapy.
While promising, investors should remain cautious as pharmacokinetic results don't guarantee clinical efficacy or regulatory approval.
The database lock announcement signals Adial Pharmaceuticals' progress in developing AD04, potentially impacting its market position. Key financial considerations include:
- R&D Milestone: This event likely triggers internal budgeting phases for the upcoming Phase 3 study, affecting near-term cash burn rates.
- Partnerships: Positive topline results could attract strategic collaborations, potentially bringing in non-dilutive funding or licensing revenues.
- Market Opportunity: The global AUD treatment market is substantial, with significant unmet needs. A successful AD04 could capture a considerable market share.
However, investors should note that clinical-stage biotech companies often face volatility. The Q4 2024 timeline for results provides a clear catalyst for potential stock movement, but substantial risks remain until FDA approval.
Topline results expected in fourth quarter of 2024
GLEN ALLEN, Va., Sept. 19, 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 database lock for the pharmacokinetics study of AD04, 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 < 10 drinks/drinking day). Topline results are expected to be announced during the fourth quarter of 2024.
Cary Claiborne, President and Chief Executive Officer of Adial, said, “We are pleased to announce database lock for our pharmacokinetics study. The data has now been transferred to independent statisticians, who will begin the data analysis process for our next FDA interaction. As we prepare for the release of topline results in the fourth quarter, our attention turns to the next critical steps, including planning for re-engagement with the FDA. The insights gained from this study will be crucial in shaping our clinical strategy for the Phase 3 study. In addition, we believe the topline results, will strengthen our position for potential strategic collaborations as we finalize planning efforts for the future clinical development of AD04.”
The single-center open-label relative bioavailability and dose proportionality study enrolled 30 healthy adult volunteers and compared the pharmacokinetic profile of AD04 when administered as an oral dose of 0.33 mg, with or without food, against a reference standard product.
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 announcing topline results during the fourth quarter of 2024, planning for re-engagement with the FDA, the insights gained from the study being crucial in shaping the Company’s clinical strategy for the Phase 3 study, the topline results strengthening the Company’s position for potential strategic collaborations, finalizing planning efforts for the future clinical development of AD04 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 release topline results for our pharmacokinetics study of AD04 as planned, 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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