Adial Pharmaceuticals Announces Last Patient Dosed in Pharmacokinetics Study of AD04 for the Treatment of Alcohol Use Disorder
Adial Pharmaceuticals (NASDAQ: ADIL) has announced the completion of patient dosing in the pharmacokinetics study of AD04, their lead investigational treatment for Alcohol Use Disorder (AUD). The study, involving 30 healthy adult volunteers, aims to optimize dosing and enhance efficacy and safety for AUD patients. Topline results are expected in the fourth quarter of 2024.
The single-center open-label study compares the pharmacokinetic profile of AD04 at a 0.33 mg oral dose, with or without food, against a reference standard. This milestone brings Adial closer to initiating their Phase 3 clinical trial and supports ongoing partnership discussions. The company plans to review the data thoroughly and engage with the FDA to align their development plan with regulatory expectations.
Adial Pharmaceuticals (NASDAQ: ADIL) ha annunciato il completamento della somministrazione ai pazienti nello studio di farmacocinetica di AD04, il loro principale trattamento in fase di sperimentazione per il Disturbo da Uso di Alcol (AUD). Lo studio, che coinvolge 30 volontari adulti sani, mira a ottimizzare il dosaggio e migliorare l'efficacia e la sicurezza per i pazienti affetti da AUD. I risultati preliminari sono attesi nel quarto trimestre del 2024.
Lo studio open-label e condotto in un singolo centro confronta il profilo farmacocinetico di AD04 a una dose orale di 0,33 mg, con o senza cibo, con uno standard di riferimento. Questo traguardo avvicina Adial all'inizio del trial clinico di Fase 3 e supporta le discussioni in corso per delle partnership. La società prevede di esaminare i dati in dettaglio e di collaborare con la FDA per allineare il proprio piano di sviluppo con le aspettative normative.
Adial Pharmaceuticals (NASDAQ: ADIL) ha anunciado la finalización de la dosificación en pacientes en el estudio de farmacocinética de AD04, su tratamiento investigacional principal para el Trastorno por Uso de Alcohol (AUD). El estudio, que involucra a 30 voluntarios adultos sanos, tiene como objetivo optimizar la dosificación y mejorar la eficacia y seguridad para los pacientes con AUD. Se esperan resultados preliminares en el cuarto trimestre de 2024.
El estudio abierto y de un solo centro compara el perfil farmacocinético de AD04 a una dosis oral de 0,33 mg, con o sin alimentos, frente a un estándar de referencia. Este hito acerca a Adial al inicio de su ensayo clínico de Fase 3 y respalda las discusiones de asociaciones en curso. La compañía planea revisar los datos exhaustivamente y colaborar con la FDA para alinear su plan de desarrollo con las expectativas regulatorias.
Adial Pharmaceuticals (NASDAQ: ADIL)는 알코올 사용 장애 (AUD)에 대한 주요 연구 치료제인 AD04의 약리학적 연구에서 환자 투약 완료를 발표했습니다. 이 연구는 30명의 건강한 성인 자원자를 포함하며, AUD 환자들의 투약을 최적화하고 효과와 안전성을 향상시키는 것을 목표로 합니다. 예비 결과는 2024년 4분기에 발표될 예정입니다.
이 단일 센터 개방형 연구는 AD04의 0.33 mg 경구 투여량을 음식 유무에 따라 비교하여 기준 표준과의 약리학적 프로필을 비교합니다. 이 이정표는 Adial이 3상 임상 시험을 시작하는 데 더 가까워지게 하며, 진행 중인 파트너십 논의를 지원합니다. 회사는 데이터를 면밀히 검토하고 FDA와 협력하여 개발 계획을 규제 기대에 맞추는 것을 계획하고 있습니다.
Adial Pharmaceuticals (NASDAQ: ADIL) a annoncé l'achèvement de l'administration aux patients dans l'étude de pharmacocinétique de AD04, leur principal traitement investigational pour le Dépendance à l'Alcool (AUD). L'étude, impliquant 30 volontaires adultes en bonne santé, vise à optimiser la posologie et à améliorer l'efficacité et la sécurité pour les patients atteints d'AUD. Les résultats préliminaires sont attendus au quatrième trimestre de 2024.
L'étude ouverte monocentrique compare le profil pharmacocinétique de AD04 à une dose orale de 0,33 mg, avec ou sans nourriture, à une norme de référence. Ce jalon rapproche Adial du début de leur essai clinique de Phase 3 et soutient les discussions sur les partenariats en cours. La société prévoit d'examiner attentivement les données et de collaborer avec la FDA pour aligner son plan de développement avec les attentes réglementaires.
Adial Pharmaceuticals (NASDAQ: ADIL) hat den Abschluss der Patientenverabreichung in der Pharmakokinetik-Studie zu AD04, ihrer primären Ermittlungsbehandlung für Alkoholkonsumstörung (AUD), bekannt gegeben. Die Studie, die 30 gesunde Erwachsene umfasst, zielt darauf ab, die Dosis zu optimieren und die Wirksamkeit und Sicherheit für AUD-Patienten zu verbessern. Vorläufige Ergebnisse werden im vierten Quartal 2024 erwartet.
Die offene Einzelzentren-Studie vergleicht das pharmakokinetische Profil von AD04 bei einer oralen Dosis von 0,33 mg, mit oder ohne Nahrung, mit einem Referenzstandard. Dieser Meilenstein bringt Adial näher an den Beginn ihrer Phase-3-Studie und unterstützt die laufenden Partnerschaftsgespräche. Das Unternehmen plant, die Daten gründlich zu überprüfen und mit der FDA zusammenzuarbeiten, um seinen Entwicklungsplan mit den regulatorischen Erwartungen in Einklang zu bringen.
- Completion of patient dosing in the pharmacokinetics study for AD04
- Advancement towards Phase 3 clinical trial initiation
- Potential optimization of AD04 dosing for improved efficacy and safety
- Ongoing partnership discussions supported by trial data
- Results of the study not yet available, creating uncertainty
- Topline results expected in Q4 2024, indicating a waiting period for important data
The completion of patient dosing in Adial Pharmaceuticals' pharmacokinetics study for AD04 is a significant milestone in the drug's development for Alcohol Use Disorder (AUD). This study, focusing on 30 healthy adult volunteers, aims to optimize dosing and enhance efficacy and safety profiles. Key points:
- The study compares AD04's pharmacokinetic profile at 0.33 mg oral dose, with and without food, against a reference standard.
- Topline results are expected in Q4 2024, which will be important for the upcoming Phase 3 trial design.
- This data will likely influence ongoing partnership discussions and FDA interactions.
While promising, investors should note that positive pharmacokinetic results don't guarantee clinical efficacy or regulatory approval. The Q4 2024 timeline for results and subsequent FDA discussions suggest that the Phase 3 trial initiation might be in early to mid-2025, impacting near-term revenue prospects.
Adial Pharmaceuticals' progress with AD04 presents a mixed investment outlook. Positives include:
- Advancement towards Phase 3 trials, potentially increasing company valuation.
- Targeted approach for AUD, addressing a
$35 billion market in the U.S. alone. - Ongoing partnership discussions, which could bring in non-dilutive capital.
However, investors should consider:
- Cash burn rate during extended development phases.
- Competitive landscape in AUD treatment.
- Regulatory hurdles and timeline to potential commercialization.
With ADIL's stock performance likely tied to these milestones, Q4 2024 results could be a significant catalyst. Investors should monitor cash position, any partnership announcements and the broader market sentiment towards biotech stocks focusing on CNS disorders.
Patient dosing has concluded for the second and last cohort of the pharmacokinetics study of AD04
Topline results expected during the fourth quarter
GLEN ALLEN, Va., Aug. 07, 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 the final patient has completed the last dose 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). 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, said, “Completion of dosing in the pharmacokinetics study for AD04 marks a significant milestone in our path toward initiating the Phase 3 clinical trial. This trial is intended to optimize dosing and, in turn, maximize the efficacy and safety of AD04 in patients with AUD. This achievement emphasizes our commitment to advancing AD04 and maximizing its likelihood of success, as a promising treatment for AUD. We believe this trial data will also play a key role as we advance ongoing partnership discussions.”
“Our immediate focus will now shift to a thorough review of the important pharmacokinetic data gathered from this study. We are eager to analyze the insights and integrate them into our comprehensive development plan. Following the receipt of the topline results, which we anticipate in the fourth quarter, we will engage in detailed discussions with the FDA to ensure our path forward is well-aligned with regulatory expectations.”
The single-center open-label relative bioavailability and dose proportionality study enrolled 30 healthy adult volunteers and will 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.
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 trial optimizing dosing and maximizing the efficacy and safety of AD04 in patients with AUD, advancing AD04 and maximizing its likelihood of success as a promising treatment for AUD, the trial data playing a key role as the Company advances ongoing partnership discussions, analyzing the insights from the trial and integrating them into the Company’s comprehensive development plan, engaging in detailed discussions with the FDA to ensure the Company’s path forward is well-aligned with regulatory expectations 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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