Adial Pharmaceuticals Files PCT Patent Application to Protect Core Assets and Extend IP Exclusivity on Core Technology to at least 2045
Adial Pharmaceuticals (NASDAQ: ADIL) has filed an update to its provisional patent application for AD04, its lead investigational therapeutic agent for Alcohol Use Disorder (AUD). The patent application, following the original filing in July 2024, aims to protect the company's core technology until at least 2045.
AD04 is a genetically targeted, serotonin-3 receptor antagonist designed to treat AUD in heavy drinking patients who consume more than 10 drinks per drinking day. The company is preparing for an End-of-Phase 2 (EOP2) Meeting with the FDA on July 29th. The updated patent application follows an extensive data review by newly hired patent counsel to strengthen Adial's intellectual property portfolio.
Adial Pharmaceuticals (NASDAQ: ADIL) ha aggiornato la sua domanda di brevetto provvisorio per AD04, il suo principale farmaco sperimentale per il trattamento del Disturbo da Uso di Alcol (AUD). La domanda di brevetto, a seguito della presentazione originale nel luglio 2024, mira a proteggere la tecnologia principale dell'azienda fino almeno al 2045.
AD04 è un antagonista del recettore della serotonina-3 geneticamente mirato, progettato per trattare l'AUD in pazienti che consumano più di 10 bevande alcoliche per giornata di consumo. L'azienda si sta preparando per un Incontro di Fine Fase 2 (EOP2) con la FDA il 29 luglio. L'aggiornamento della domanda di brevetto segue una revisione approfondita dei dati da parte di un nuovo consulente brevettuale, al fine di rafforzare il portafoglio di proprietà intellettuale di Adial.
Adial Pharmaceuticals (NASDAQ: ADIL) ha presentado una actualización de su solicitud provisional de patente para AD04, su principal agente terapéutico en investigación para el Trastorno por Consumo de Alcohol (AUD). La solicitud de patente, tras la presentación original en julio de 2024, busca proteger la tecnología central de la empresa al menos hasta 2045.
AD04 es un antagonista del receptor de serotonina-3 dirigido genéticamente, diseñado para tratar el AUD en pacientes que consumen más de 10 bebidas alcohólicas por día de consumo. La empresa se está preparando para una Reunión de Fin de Fase 2 (EOP2) con la FDA el 29 de julio. La actualización de la solicitud de patente sigue a una revisión exhaustiva de datos por parte de un nuevo asesor de patentes para fortalecer la cartera de propiedad intelectual de Adial.
Adial Pharmaceuticals (NASDAQ: ADIL)은(는) 주요 임상 치료제인 AD04에 대한 임시 특허 출원을 업데이트했습니다. AD04는 알코올 사용 장애(AUD) 치료를 위한 약물입니다. 2024년 7월 최초 출원 이후 이번 특허 출원은 회사의 핵심 기술을 최소 2045년까지 보호하는 것을 목표로 합니다.
AD04는 유전적으로 표적화된 세로토닌-3 수용체 길항제로, 하루 음주량이 10잔 이상인 중증 음주 환자의 AUD 치료를 위해 개발되었습니다. 회사는 7월 29일 FDA와의 2상 종료 회의(EOP2)를 준비 중입니다. 이번 특허 출원 업데이트는 새로 고용된 특허 변호사의 광범위한 데이터 검토를 거쳐 Adial의 지적 재산권 포트폴리오를 강화하기 위한 것입니다.
Adial Pharmaceuticals (NASDAQ : ADIL) a déposé une mise à jour de sa demande de brevet provisoire pour AD04, son principal agent thérapeutique en cours d'investigation pour le trouble lié à l'utilisation d'alcool (AUD). La demande de brevet, suite au dépôt initial en juillet 2024, vise à protéger la technologie clé de l'entreprise jusqu'à au moins 2045.
AD04 est un antagoniste génétiquement ciblé du récepteur de la sérotonine-3, conçu pour traiter l'AUD chez les patients consommateurs excessifs d'alcool, buvant plus de 10 verres par jour de consommation. La société se prépare à une réunion de fin de phase 2 (EOP2) avec la FDA le 29 juillet. La mise à jour de la demande de brevet fait suite à un examen approfondi des données par un nouveau conseiller en brevets afin de renforcer le portefeuille de propriété intellectuelle d'Adial.
Adial Pharmaceuticals (NASDAQ: ADIL) hat ein Update zu seiner vorläufigen Patentanmeldung für AD04, seinen führenden experimentellen Wirkstoff zur Behandlung der Alkoholgebrauchsstörung (AUD), eingereicht. Die Patentanmeldung, die auf der ursprünglichen Einreichung im Juli 2024 basiert, soll die Kerntechnologie des Unternehmens mindestens bis 2045 schützen.
AD04 ist ein genetisch gezielter Serotonin-3-Rezeptor-Antagonist, der zur Behandlung von AUD bei stark trinkenden Patienten entwickelt wurde, die mehr als 10 Getränke pro Trinktag konsumieren. Das Unternehmen bereitet sich auf ein Ende-Phase-2-Treffen (EOP2) mit der FDA am 29. Juli vor. Die aktualisierte Patentanmeldung folgt einer umfassenden Datenüberprüfung durch neu engagierte Patentanwälte, um das geistige Eigentumsportfolio von Adial zu stärken.
- Patent protection extension until at least 2045 for core technology
- Upcoming FDA End-of-Phase 2 Meeting scheduled for July 29th
- Strengthened intellectual property strategy with new patent counsel
- None.
Application Update Based on Extensive Review of Data
GLEN ALLEN, Va., July 09, 2025 (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 filing of an update to the provisional patent application for AD04 which was filed in July 2024, 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). The patent, once granted, is expected to protect Adial’s core assets out to at least 2045.
Cary Claiborne, President and Chief Executive Officer of Adial, commented, “As we continue to advance AD04 to the EOP2 Meeting with FDA coming up on July 29th, the new patent application and its expected approval will extend protection of the core assets of Adial out to at least 2045. This application is the result of an extensive examination of data and information which occurred after Adial hired new patent counsel to bolster and leverage Adial’s intellectual property portfolio.”
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 Company’s new patent application for AD04 and its expected approval, the patent protecting Adial’s core assets out to at least 2045, continuing to advance the AD04 program 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
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