Adial Pharmaceuticals Advances to Second Cohort in Pharmacokinetics Study of AD04 for the Treatment of Alcohol Use Disorder
Adial Pharmaceuticals (NASDAQ: ADIL) has advanced to the second cohort in its pharmacokinetics study of AD04, a genetically targeted therapeutic agent for Alcohol Use Disorder (AUD). The study, initiated in June 2024, is expected to conclude in Q4 2024 with topline results from both cohorts. This single-center, open-label study will enroll up to 30 healthy adult volunteers to compare the pharmacokinetic profile of AD04 when administered as an oral dose of 0.33 mg with or without food against a reference standard product.
CEO Cary Claiborne expressed satisfaction with the study's progress, noting that the results will provide important insights for designing their upcoming Phase 3 Clinical Trial. Adial plans to engage with the FDA after receiving the topline data to seek feedback on their Phase 3 program design.
Adial Pharmaceuticals (NASDAQ: ADIL) è avanzata alla seconda coorte nel suo studio di farmacocinetica su AD04, un agente terapeutico geneticamente mirato per il Disturbo da Uso di Alcol (AUD). Lo studio, avviato a giugno 2024, si prevede si concluderà nel quarto trimestre del 2024 con risultati preliminari provenienti da entrambe le coorti. Questo studio monocentrico, in aperto, recluterà fino a 30 volontari adulti sani per confrontare il profilo farmacocinetico di AD04 somministrato come dose orale di 0,33 mg con o senza cibo rispetto a un prodotto standard di riferimento.
Il CEO Cary Claiborne ha espresso soddisfazione per i progressi dello studio, sottolineando che i risultati forniranno informazioni importanti per la progettazione del loro prossimo Studio Clinico di Fase 3. Adial intende interagire con la FDA dopo aver ricevuto i dati preliminari per chiedere feedback sulla progettazione del loro programma di Fase 3.
Adial Pharmaceuticals (NASDAQ: ADIL) ha avanzado a la segunda cohorte en su estudio de farmacocinética de AD04, un agente terapéutico dirigido genéticamente para el Trastorno por Uso de Alcohol (AUD). El estudio, iniciado en junio de 2024, se espera que concluya en el cuarto trimestre de 2024 con resultados preliminares de ambas cohortes. Este estudio monocéntrico, abierto, inscribirá hasta 30 voluntarios adultos sanos para comparar el perfil farmacocinético de AD04 administrado como una dosis oral de 0.33 mg con o sin comida en comparación con un producto de referencia estándar.
El CEO Cary Claiborne expresó satisfacción con el progreso del estudio, señalando que los resultados proporcionarán información importante para el diseño de su próximo Estudio Clínico de Fase 3. Adial planea interactuar con la FDA después de recibir los datos preliminares para buscar retroalimentación sobre el diseño de su programa de Fase 3.
Adial Pharmaceuticals (NASDAQ: ADIL)는 알코올 사용 장애 (AUD)를 위한 유전자 표적 치료제인 AD04의 약물동태학 연구에서 두 번째 코호트로 나아갔습니다. 2024년 6월에 시작된 이 연구는 2024년 4분기에 두 코호트에서의 주요 결과를 발표할 예정입니다. 이 단일 센터 공개 연구는 최대 30명의 건강한 성인 자원자를 모집하여 음식이 있거나 없을 때 각각 0.33mg의 경구 용량으로 투여된 AD04의 약물동태학적 프로필을 표준 참조 제품과 비교합니다.
CEO Cary Claiborne은 연구의 진행 상황에 만족감을 표시하며, 그 결과가 향후 3상 임상 시험 설계를 위한 중요한 통찰력을 제공할 것이라고 언급했습니다. Adial은 주요 데이터 수집 후 FDA와 협력하여 3상 프로그램 디자인에 대한 피드백을 요청할 계획입니다.
Adial Pharmaceuticals (NASDAQ: ADIL) a avancé à la deuxième cohorte de son étude de pharmacocinétique sur AD04, un agent thérapeutique ciblé génétiquement pour le trouble de l'utilisation de l'alcool (AUD). L'étude, lancée en juin 2024, devrait se terminer au quatrième trimestre 2024 avec des résultats préliminaires des deux cohortes. Cette étude monocentrique, en ouvert, recrutera jusqu'à 30 volontaires adultes en bonne santé pour comparer le profil pharmacocinétique d'AD04 lorsqu'il est administré sous forme de dose orale de 0,33 mg avec ou sans nourriture par rapport à un produit de référence standard.
Le PDG Cary Claiborne a exprimé sa satisfaction quant aux progrès de l'étude, notant que les résultats fourniront des informations importantes pour concevoir leur prochaine étude clinique de phase 3. Adial prévoit d'engager un dialogue avec la FDA après avoir reçu les données préliminaires afin de solliciter des retours sur la conception de leur programme de phase 3.
Adial Pharmaceuticals (NASDAQ: ADIL) ist zur zweiten Kohorte in ihrer pharmakokinetischen Studie von AD04, einem genetisch zielgerichteten Therapeutikum für die Alkoholkonsumstörung (AUD), übergegangen. Die im Juni 2024 gestartete Studie wird voraussichtlich im vierten Quartal 2024 mit vorläufigen Ergebnissen aus beiden Kohorten abgeschlossen. Diese einzentralisierte, offene Studie wird bis zu 30 gesunde erwachsene Freiwillige einschließen, um das pharmakokinetische Profil von AD04 zu vergleichen, wenn es als orale Dosis von 0,33 mg mit oder ohne Nahrung im Vergleich zu einem Referenzstandardprodukt verabreicht wird.
CEO Cary Claiborne äußerte Zufriedenheit mit den Fortschritten der Studie und betonte, dass die Ergebnisse wichtige Einblicke für die Gestaltung ihrer bevorstehenden Phase-3-Studie liefern werden. Adial plant, nach Erhalt der vorläufigen Daten mit der FDA in Kontakt zu treten, um Feedback zu ihrem Design des Phase-3-Programms zu erhalten.
- Successful completion of the first cohort in the AD04 pharmacokinetics study
- Advancement to the second cohort as planned, staying on track with projected timeline
- Anticipated completion of the study in Q4 2024, with topline results expected in the same quarter
- Study results will inform the design of the upcoming Phase 3 Clinical Trial
- None.
Insights
The transition to the second cohort in the AD04 pharmacokinetics study is a noteworthy milestone for Adial Pharmaceuticals. This progress signifies that the initial cohort's results were promising enough to warrant further investigation. For retail investors, the successful advancement in clinical trials often correlates with increased investor confidence, as it reduces the perceived risk surrounding the efficacy and safety of the drug. Moreover, reaching this stage in the study keeps the company on track with its projected timeline, which can be critical for maintaining market trust and momentum.
It is essential to understand that pharmacokinetics studies are fundamentally about understanding how a drug is absorbed, distributed, metabolized and excreted in the body. The data from these studies are important in designing effective dosage regimens for subsequent clinical trials. The fact that Adial is gathering bioavailability and dose proportionality data puts them in a solid position to refine AD04's dosing protocols, which directly impacts the drug's success in later-phase trials.
From a financial perspective, the advancement to the second cohort in the AD04 study represents positive forward momentum for Adial Pharmaceuticals. Clinical trial progress is a critical value driver for biopharmaceutical companies. The market tends to react favorably to news indicating that a drug candidate is moving successfully through the clinical trial phases, often resulting in a short-term boost in stock price.
Investors should also keep an eye on the upcoming milestones mentioned, such as the announcement of topline results in the fourth quarter of 2024. Positive results could provide a significant catalyst for the stock and enhance the company's valuation. Furthermore, the initiation of Phase 3 trials, pending favorable outcomes, will likely lead to increased investor interest and potentially more substantial institutional investment.
The market for treatments targeting Alcohol Use Disorder (AUD) is both significant and underserved. AD04's progression in clinical trials places Adial Pharmaceuticals in a competitive position within this niche market. The data obtained from the pharmacokinetics study will be essential in differentiating AD04 from existing therapies in terms of efficacy, safety and patient compliance.
Given the global burden of AUD and the limited options for genetically targeted treatments, AD04's development could fill a critical gap in the market. If successful, this could lead to substantial market share capture for Adial. Additionally, the potential for engaging with the FDA post-study for Phase 3 design feedback is an encouraging step, showcasing the company’s proactive approach to regulatory alignment and market readiness.
Patient dosing in the second cohort has commenced following the successful completion of the first cohort
GLEN ALLEN, Va., July 23, 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 the progression to the second cohort in 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), following the successful completion of the first cohort. Topline results from both cohorts are expected to be announced during the fourth quarter of 2024.
Cary Claiborne, President and Chief Executive Officer of Adial commented, “We are pleased with the progress of our pharmacokinetics study of AD04. The successful completion of the first cohort allows us to advance to the second cohort as planned, staying on track with our projected timeline. The results from both cohorts will offer invaluable insights that are critical for the design of our upcoming Phase 3 Clinical Trial. We anticipate engaging with the FDA following receipt of the topline data from this study and seek their feedback on the overall design of our Phase 3 program.”
The pharmacokinetics study was initiated in June 2024 and is expected to be completed during the fourth quarter of 2024. The single-center open-label relative bioavailability and dose proportionality study will enroll up to 30 healthy adult volunteers and compare the pharmacokinetic profile of AD04 when administered as an oral dose of 0.33 mg with or without food against a reference standard product. This study will provide valuable information on the pharmacokinetic properties of AD04.
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 from both cohorts during the fourth quarter of 2024, the results from both cohorts offering invaluable insights critical for the design of the Company’s upcoming Phase 3 Clinical Trial, engaging with the FDA following receipt of the topline data from the pharmacokinetics study and seeking their feedback on the overall design of the Company’s Phase 3 program, completing the study during the fourth quarter of 2024, enrolling up to 30 healthy adult volunteers for the single-center open-label relative bioavailability and dose proportionality study to compare the pharmacokinetic profile of AD04 when administered as an oral dose of 0.33 mg with or without food against a reference standard product, the study providing valuable information on the pharmacokinetic properties 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 complete the second cohort of the pharmacokinetics study during the fourth quarter of 2024 and announce topline results from both cohorts, our ability to use the results from both cohorts to develop insights critical for the design of our upcoming Phase 3 Clinical Trial, our ability to obtain feedback on the overall design of our Phase 3 program from the FDA following receipt of the topline data from the pharmacokinetics study, 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 current status of Adial Pharmaceuticals' AD04 pharmacokinetics study for Alcohol Use Disorder?
When does Adial Pharmaceuticals expect to announce topline results from the AD04 pharmacokinetics study?
How many participants are expected to be enrolled in Adial Pharmaceuticals' AD04 pharmacokinetics study?
What is the purpose of Adial Pharmaceuticals' current pharmacokinetics study for AD04?
