Adial Pharmaceuticals Awarded New U.S. Patent Covering Genotype-Specific Treatment of Opioid-Related Disorders
Adial Pharmaceuticals (NASDAQ: ADIL) has been awarded U.S. patent number 12,221,654 on February 11, 2025, expanding its molecular genetic approach to diagnosing and treating addiction disorders. The patent covers methods for identifying patients with specific genetic markers linked to substance use disorders and treating them with AD04, the company's investigational drug.
The treatment specifically involves detecting the TT genotype of rs1042173 in the serotonin transporter gene (SLC6A4) and administering AD04 to patients. This approach is designed for treating various conditions including opioid dependence, opioid abuse, and alcohol dependence. The company aims to deliver personalized treatments by combining genetic diagnostics with precision medicine, targeting patients who may not respond to conventional therapies.
Adial Pharmaceuticals (NASDAQ: ADIL) ha ricevuto il brevetto statunitense numero 12.221.654 l'11 febbraio 2025, ampliando il suo approccio genetico molecolare per la diagnosi e il trattamento dei disturbi da dipendenza. Il brevetto copre metodi per identificare pazienti con specifici marcatori genetici associati ai disturbi da uso di sostanze e per trattarli con AD04, il farmaco in fase di sperimentazione dell'azienda.
Il trattamento prevede specificamente la rilevazione del genotipo TT di rs1042173 nel gene del trasportatore della serotonina (SLC6A4) e la somministrazione di AD04 ai pazienti. Questo approccio è progettato per trattare varie condizioni tra cui dipendenza da oppioidi, abuso di oppioidi e dipendenza da alcol. L'azienda punta a fornire trattamenti personalizzati combinando diagnosi genetiche con medicina di precisione, mirando a pazienti che potrebbero non rispondere alle terapie convenzionali.
Adial Pharmaceuticals (NASDAQ: ADIL) ha sido otorgada la patente estadounidense número 12.221.654 el 11 de febrero de 2025, ampliando su enfoque genético molecular para diagnosticar y tratar trastornos de adicción. La patente cubre métodos para identificar pacientes con marcadores genéticos específicos relacionados con trastornos por uso de sustancias y tratarlos con AD04, el medicamento en investigación de la empresa.
El tratamiento implica específicamente la detección del genotipo TT de rs1042173 en el gen transportador de serotonina (SLC6A4) y la administración de AD04 a los pacientes. Este enfoque está diseñado para tratar diversas condiciones, incluyendo dependencia de opioides, abuso de opioides y dependencia de alcohol. La empresa tiene como objetivo ofrecer tratamientos personalizados combinando diagnósticos genéticos con medicina de precisión, enfocándose en pacientes que pueden no responder a terapias convencionales.
아디알 제약 (NASDAQ: ADIL)은 2025년 2월 11일 미국 특허 번호 12,221,654를 부여받아 중독 장애를 진단하고 치료하기 위한 분자 유전학적 접근 방식을 확장했습니다. 이 특허는 물질 사용 장애와 관련된 특정 유전자 마커를 가진 환자를 식별하고 AD04로 치료하는 방법을 다룹니다.
치료는 특히 세로토닌 수송체 유전자(SLC6A4)의 rs1042173에서 TT 유전자형을 감지하고 환자에게 AD04를 투여하는 것을 포함합니다. 이 접근 방식은 오피오이드 의존, 오피오이드 남용 및 알코올 의존을 포함한 다양한 상태를 치료하기 위해 설계되었습니다. 이 회사는 유전자 진단과 정밀 의학을 결합하여 개인 맞춤형 치료를 제공하는 것을 목표로 하며, 전통적인 치료에 반응하지 않을 수 있는 환자들을 대상으로 하고 있습니다.
Adial Pharmaceuticals (NASDAQ: ADIL) a reçu le brevet américain numéro 12.221.654 le 11 février 2025, élargissant son approche génétique moléculaire pour diagnostiquer et traiter les troubles de la dépendance. Le brevet couvre des méthodes permettant d'identifier des patients présentant des marqueurs génétiques spécifiques liés aux troubles liés à l'usage de substances et de les traiter avec AD04, le médicament en cours d'investigation de l'entreprise.
Le traitement implique spécifiquement la détection du génotype TT de rs1042173 dans le gène du transporteur de la sérotonine (SLC6A4) et l'administration d'AD04 aux patients. Cette approche est conçue pour traiter diverses conditions, y compris dépendance aux opioïdes, abus d'opioïdes et dépendance à l'alcool. L'entreprise vise à offrir des traitements personnalisés en combinant diagnostics génétiques et médecine de précision, ciblant des patients qui pourraient ne pas répondre aux thérapies conventionnelles.
Adial Pharmaceuticals (NASDAQ: ADIL) wurde am 11. Februar 2025 das US-Patent Nummer 12.221.654 erteilt, das ihren molekulargenetischen Ansatz zur Diagnose und Behandlung von Suchtstörungen erweitert. Das Patent umfasst Methoden zur Identifizierung von Patienten mit spezifischen genetischen Markern, die mit Substanzgebrauchsstörungen verbunden sind, und deren Behandlung mit AD04, dem experimentellen Medikament des Unternehmens.
Die Behandlung umfasst speziell die Erkennung des TT-Genotyps von rs1042173 im Serotonintransportergen (SLC6A4) und die Verabreichung von AD04 an die Patienten. Dieser Ansatz ist darauf ausgelegt, verschiedene Erkrankungen zu behandeln, einschließlich Opioidabhängigkeit, Opioidmissbrauch und Alkoholabhängigkeit. Das Unternehmen zielt darauf ab, personalisierte Behandlungen anzubieten, indem es genetische Diagnostik mit Präzisionsmedizin kombiniert und sich auf Patienten konzentriert, die möglicherweise nicht auf herkömmliche Therapien ansprechen.
- Secured new U.S. patent expanding intellectual property protection for AD04 drug
- Patent covers both diagnostic methods and treatment applications
- Potential market expansion beyond alcohol use disorder into opioid dependence treatment
- AD04 still in investigational phase, not yet FDA approved
- No immediate revenue impact from patent issuance
Insights
The issuance of patent 12,221,654 marks a pivotal development for Adial Pharmaceuticals, substantially reinforcing their intellectual property position in personalized addiction treatment. The patent's scope is particularly significant as it extends beyond alcohol use disorder to encompass opioid-related disorders, effectively doubling the potential therapeutic applications of their AD04 drug candidate.
The patent's focus on genetic markers, specifically the TT genotype of rs1042173 in the serotonin transporter gene, represents a sophisticated approach to addiction treatment. This precision medicine strategy addresses a critical gap in current addiction therapeutics, where one-size-fits-all treatments often show efficacy. The ability to identify genetic markers that predict treatment response could significantly improve patient outcomes and reduce healthcare costs.
From a market perspective, this patent creates multiple strategic advantages:
- Enhanced market exclusivity for AD04 in both alcohol and opioid use disorders, potentially through the late 2030s
- Expanded addressable market into the opioid dependence space, which represents a
$3.1 billion market opportunity - Potential for premium pricing based on the companion diagnostic approach
- Barriers to entry for competitors attempting to develop similar genetic-based treatments
The patent's timing is particularly strategic as the healthcare industry increasingly embraces personalized medicine approaches. This positions Adial at the intersection of two growing trends: precision medicine and addiction treatment, potentially making them an attractive partner for larger pharmaceutical companies seeking to expand their presence in these areas.
However, investors should note that significant development work remains before these new patent claims can be commercially realized. The company will need to conduct additional clinical trials to validate AD04's efficacy in opioid use disorder, requiring substantial time and capital investment. The companion diagnostic approach, while potentially more effective, also adds complexity to the regulatory pathway and market adoption strategy.
New Patent expands patent estate covering Adial’s unique molecular genetic approach to diagnosing and potentially treating alcohol and drug dependence
GLEN ALLEN, Va., Feb. 12, 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, today announced patent number 12,221,654 was issued on February 11, 2025, by the United States Patent and Trademark Office.
This patent expands the covered methods of identifying patients with specific genetic markers linked to substance use disorders and treating them with AD04, the Company’s investigational new drug product. The treatment approach involves detecting the TT genotype of rs1042173 in the serotonin transporter gene (SLC6A4) and administering AD04. These treatment methods are tailored for individuals suffering from disorders such as opioid dependence, opioid abuse, alcohol dependence, and other related conditions.
“This patent is an important milestone for Adial Pharmaceuticals as we continue our mission to create innovative, personalized treatments for addiction,” said Cary Claiborne, CEO of Adial Pharmaceuticals. “Our research not only helps us understand the genetic underpinnings of addiction but also positions us to deliver solutions that are more effective and tailored to individual patients. We believe AD04 has significant potential to treat opioid use disorder and other drug dependencies in addition to our initial indication of alcohol use disorder. By combining genetic diagnostics with precision medicine, we aim to improve outcomes for patients who may not respond to traditional treatments.”
About Adial Pharmaceuticals, Inc.
Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of therapies for the treatment and prevention of addiction 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 proprietary companion diagnostic genetic test. ONWARD showed promising results in reducing heavy 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.
If you are interested in exploring partnership opportunities with Adial, we invite you to reach out to us (BD@adialpharma.com) to discuss how our joint efforts can bring about positive change in the millions of patients who are struggling with addiction.
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 creating innovative, personalized treatments for addiction, understanding the genetic underpinnings of addiction, positioning the Company to deliver solutions that are more effective and tailored to individual patients, AD04 having significant potential to treat opioid use disorder and other drug dependencies in addition alcohol use disorder, improving outcomes for patients who may not respond to traditional treatments by combining genetic diagnostics with precision medicine 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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