Adial Pharmaceuticals Signs Agreement with Boudicca Dx to Advance Regulatory Strategy for Companion Diagnostic Genetic Test for AD04
Adial Pharmaceuticals (NASDAQ: ADIL) has partnered with Boudicca Dx to advance the regulatory strategy for its companion diagnostic genetic test. This test is designed to accompany AD04, Adial's lead investigational asset for Alcohol Use Disorder (AUD) treatment. Boudicca Dx will support Adial in ensuring the test's compliance with FDA guidelines, a important step in Adial's regulatory strategy and preparation for its planned Phase 3 program.
The collaboration aims to validate the companion diagnostic both technically and clinically, supporting patient identification and recruitment for AD04 trials. This partnership is seen as a key component in Adial's mission to develop a first-in-class precision medicine for AUD treatment, addressing a significant unmet need in a disease affecting over 30 million people in the US and causing 3 million deaths worldwide annually.
Adial Pharmaceuticals (NASDAQ: ADIL) ha stretto una collaborazione con Boudicca Dx per avanzare la strategia regolatoria del suo test genetico diagnostico companion. Questo test è progettato per accompagnare AD04, l'asset investigativo principale di Adial per il trattamento del Disturbo da Uso di Alcol (AUD). Boudicca Dx supporterà Adial nell'assicurare la conformità del test alle linee guida della FDA, un passo importante nella strategia regolatoria di Adial e nella preparazione per il suo programmato programma di Fase 3.
La collaborazione mira a validare il diagnostico companion sia a livello tecnico che clinico, supportando l'identificazione e il reclutamento dei pazienti per le sperimentazioni di AD04. Questa partnership è vista come un componente chiave nella missione di Adial di sviluppare un farmaco di precisione di prima classe per il trattamento dell'AUD, affrontando un'importante esigenza insoddisfatta in una malattia che colpisce oltre 30 milioni di persone negli Stati Uniti e causa 3 milioni di decessi in tutto il mondo ogni anno.
Adial Pharmaceuticals (NASDAQ: ADIL) ha formado una alianza con Boudicca Dx para avanzar en la estrategia regulatoria de su prueba diagnóstica genética companion. Esta prueba está diseñada para acompañar a AD04, el activo de investigación principal de Adial para el tratamiento del Trastorno por Consumo de Alcohol (AUD). Boudicca Dx apoyará a Adial en asegurar que la prueba cumpla con las normas de la FDA, un paso importante en la estrategia regulatoria de Adial y en la preparación para su previsto programa de Fase 3.
La colaboración tiene como objetivo validar el diagnóstico companion tanto técnica como clínicamente, apoyando la identificación y reclutamiento de pacientes para los ensayos de AD04. Esta asociación se considera un componente clave en la misión de Adial de desarrollar un medicamento de precisión de primera clase para el tratamiento del AUD, abordando una necesidad significativa no satisfecha en una enfermedad que afecta a más de 30 millones de personas en EE.UU. y causa 3 millones de muertes anualmente en todo el mundo.
Adial Pharmaceuticals (NASDAQ: ADIL)는 Boudicca Dx와 협력하여 동반 진단 유전자 검사에 대한 규제 전략을 발전시킵니다. 이 검사는 Adial의 주요 연구 자산인 AD04와 함께 사용되도록 설계되었습니다. Boudicca Dx는 Adial이 이 검사가 FDA 지침을 준수하도록 지원할 것이며, 이는 Adial의 규제 전략 및 계획된 3상 프로그램 준비에 있어 중요한 단계입니다.
이 협력은 동반 진단을 기술적 및 임상적으로 검증하여 AD04 시험을 위한 환자 식별 및 모집을 지원하는 것을 목표로 하고 있습니다. 이 파트너십은 AUD 치료를 위한 1세대 정밀 의약품 개발을 위한 Adial의 사명에 중요한 요소로 간주되며, 이는 미국에서 3천만 명 이상의 사람들에게 영향을 미치고 매년 전 세계적으로 300만 명의 사망을 초래하는 질병입니다.
Adial Pharmaceuticals (NASDAQ: ADIL) a noué un partenariat avec Boudicca Dx pour faire avancer la stratégie réglementaire de son test génétique diagnostique companion. Ce test est conçu pour accompagner AD04, le principal actif d'investigation d'Adial pour le traitement du trouble lié à l'usage de l'alcool (AUD). Boudicca Dx soutiendra Adial pour s'assurer que le test est conforme aux directives de la FDA, une étape importante dans la stratégie réglementaire d'Adial et dans la préparation de son programme de Phase 3 prévu.
La collaboration vise à valider le diagnostic companion sur le plan technique et clinique, soutenant ainsi l'identification et le recrutement des patients pour les essais d'AD04. Ce partenariat est considéré comme un élément clé dans la mission d'Adial de développer un médicament de précision de première classe pour le traitement de l'AUD, répondant à un besoin médical non satisfait dans une maladie touchant plus de 30 millions de personnes aux États-Unis et causant 3 millions de décès dans le monde chaque année.
Adial Pharmaceuticals (NASDAQ: ADIL) hat eine Partnerschaft mit Boudicca Dx geschlossen, um die regulatorische Strategie für seinen Begleitdiagnosetest voranzutreiben. Dieser Test ist dafür konzipiert, AD04 zu begleiten, das führende Forschungsprodukt von Adial zur Behandlung von Alkoholkonsumstörungen (AUD). Boudicca Dx wird Adial unterstützen, um sicherzustellen, dass der Test den FDA-Vorgaben entspricht, ein wichtiger Schritt in Adials regulatorischer Strategie und Vorbereitung auf das geplante Phase-3-Programm.
Die Zusammenarbeit zielt darauf ab, den Begleitdiagnosetest sowohl technisch als auch klinisch zu validieren, um die Patientenidentifikation und -rekrutierung für die AD04-Studien zu unterstützen. Diese Partnerschaft wird als Schlüsselkomponente in Adials Mission angesehen, ein erstklassiges Präzisionsmedikament zur Behandlung von AUD zu entwickeln und damit ein erhebliches unerfülltes Bedürfnis bei einer Krankheit zu adressieren, die über 30 Millionen Menschen in den USA betrifft und jährlich 3 Millionen Todesfälle weltweit verursacht.
- Partnership with Boudicca Dx to advance regulatory strategy for companion diagnostic test
- Preparation for Phase 3 study of AD04 for Alcohol Use Disorder treatment
- Potential development of first-in-class precision medicine for AUD
- None.
Insights
This collaboration marks a significant step towards advancing AD04, a potential breakthrough in Alcohol Use Disorder (AUD) treatment. The partnership with Boudicca Dx to develop a companion diagnostic test is important for several reasons:
- It enables precise patient identification, potentially improving clinical trial outcomes and future treatment efficacy.
- FDA validation of the diagnostic test strengthens Adial's regulatory strategy, potentially expediting the approval process.
- This approach aligns with the growing trend of personalized medicine in addiction treatment, addressing a critical gap in current AUD therapies.
However, investors should note that success is not guaranteed. The Phase 3 trial and FDA approval are still significant hurdles. The market potential is substantial, given the
Adial's partnership with Boudicca Dx is a strategic move to navigate the complex FDA regulatory landscape for companion diagnostics. Key points to consider:
- The FDA has stringent requirements for validating companion diagnostics, which are critical for the approval of targeted therapies like AD04.
- Boudicca's expertise could potentially streamline the regulatory process, reducing time and costs associated with FDA interactions.
- A successfully validated companion diagnostic could provide Adial with a competitive advantage in the AUD treatment market.
However, the regulatory path for novel companion diagnostics can be challenging and time-consuming. Investors should be prepared for potential delays or additional studies if required by the FDA. The success of this strategy could significantly impact Adial's timeline to market and overall valuation.
Adial's focus on developing a precision medicine approach for AUD treatment positions them uniquely in a large, underserved market. Key market considerations include:
- The global AUD treatment market is substantial, with
3 million deaths worldwide annually highlighting the urgent need for effective therapies. - Precision medicine in addiction treatment is an emerging trend, potentially offering Adial first-mover advantage.
- The companion diagnostic could create a high barrier to entry for competitors, potentially securing a significant market share if AD04 proves successful.
However, market adoption of new addiction treatments can be slow and healthcare provider education will be crucial. The success of AD04 and its companion diagnostic could reshape the AUD treatment landscape, but investors should be aware of the long-term nature of this potential market transformation.
Boudicca will support and advise Adial on its companion diagnostic genetic test to ensure compliance with FDA guidelines
GLEN ALLEN, Va., Aug. 13, 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 a collaboration with Boudicca Dx, LLC, a global precision medicine testing accelerator.
Under the agreement, Boudicca will support Adial in advancing its technical and regulatory strategy for the Company’s companion diagnostic genetic test, to ensure it is validated both technically and clinically per FDA guidelines as part of Adial’s regulatory strategy for its lead investigational asset, AD04, a genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD). Adial’s companion diagnostic is intended to accompany AD04 in identifying potential patients, including recruitment for the Company’s planned Phase 3 program.
Cary Claiborne, President and Chief Executive Officer of Adial commented, “As we continue to prepare for the Phase 3 study for AD04, this agreement with Boudicca Dx is another key component toward achieving clinical success and is expected to support our next FDA interaction. Kelly Gordon, the Chief Executive Officer and founder of Boudicca Dx, along with her team, are the ideal partners for Adial to develop a comprehensive clinical, regulatory and commercial strategy for the AD04 companion diagnostic. Our mission is to bring a first in class precision medicine to the treatment of AUD, and having our companion diagnostic validated by the FDA is a critical step in the process.”
Kelly Gordon commented, “The Boudicca Dx team is excited to support the development of a first-in-class companion diagnostic test for AD04, a precision medicine designed to treat patients with Alcohol Use Disorder. This disease affects more than 30 million people in the US alone and causes 3 million deaths worldwide each year. There is a high unmet need for a targeted therapy and its companion diagnostic test.”
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 Boudicca supporting us in advancing our technical and regulatory strategy, our companion diagnostic accompanying AD04 in identifying potential patients, including recruitment for our planned Phase 3 program, continuing to prepare for the Phase 3 study for AD04, the agreement with Boudicca being another key component toward achieving clinical success and supporting our next FDA interaction. 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 companion diagnostic being able to accompany AD04 in identifying potential patients, including recruitment for our planned Phase 3 program, our ability to prepare and commence the planned Phase 3 program, our agreement with Boudicca supporting our next FDA interaction and clinical success, 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 purpose of Adial Pharmaceuticals' partnership with Boudicca Dx?
What is AD04 and what condition does it target?
How many people are affected by Alcohol Use Disorder according to the press release?
What is the significance of the companion diagnostic test for Adial Pharmaceuticals (ADIL)?
