Adial Pharmaceuticals Partners with Genomind for Precision Medicine Testing Solution
Adial Pharmaceuticals (NASDAQ: ADIL) announced completion of analytical validation for a cheek swab collection method and companion gene test developed with Genomind to identify serotonergic SNPs (HTR3A, HTR3B, SLC6A4) for AD04 clinical and future commercial use.
Genomind validated accuracy, reproducibility, and robustness across diverse samples and operators, reporting 100% concordance. The test detects long/short SLC6A4 promoter forms. FDA confirmed use of the test in Phase 3 is Non‑Significant Risk (NSR) and an IDE is not required. The AG+ biomarker is present in ~14% of the population. Adial also noted a new patent filing for AD04 expected to extend exclusivity to 2045.
Adial Pharmaceuticals (NASDAQ: ADIL) ha annunciato il completamento della convalida analitica per un metodo di raccolta con tampone della guancia (cheek swab) e per un test genetico associato sviluppato insieme a Genomind per identificare SNP serotoninergici (HTR3A, HTR3B, SLC6A4) per uso clinico AD04 e per uso commerciale futuro.
Genomind ha validato accuratezza, riproducibilità e robustezza su campioni e operatori diversi, riportando 100% di concordanza. Il test rileva forme promotrici lunghe/corte di SLC6A4. La FDA ha confermato che l'uso del test nella fase 3 è Rischio Non Significativo (NSR) e che non è richiesto un IDE. Il biomarcatore AG+ è presente in circa il 14% della popolazione. Adial ha inoltre segnalato una nuova domanda di brevetto per AD04 che dovrebbe estendere l'esclusività fino al 2045.
Adial Pharmaceuticals (NASDAQ: ADIL) anunció la finalización de la validación analítica de un método de recogida con hisopo de la mejilla y de la prueba genética complementaria desarrollados con Genomind para identificar SNP serotoninérgicos (HTR3A, HTR3B, SLC6A4) para uso clínico AD04 y para uso comercial futuro.
Genomind validó la precisión, la reproducibilidad y la robustez en muestras y operadores diversos, reportando una concordancia del 100%. La prueba detecta formas promotoras largas/cortas de SLC6A4. La FDA confirmó que el uso de la prueba en la Fase 3 es de riesgo no significativo (NSR) y no se requiere un IDE. El biomarcador AG+ está presente en ~el 14% de la población. Adial también señaló una nueva solicitud de patente para AD04 que se espera extienda la exclusividad hasta 2045.
Adial Pharmaceuticals (NASDAQ: ADIL)은 Genomind와 함께 개발한 볼 뺨 채취용 면봉 방법과 동반 유전자 검사의 분석 검증을 완료했다고 발표했습니다. 이는 AD04 임상 및 향후 상업적 사용을 위해 세로토닌성 SNP(HRT3A, HTR3B, SLC6A4)을 식별합니다.
Genomind는 다양한 샘플과 작업자에 걸친 정확도, 재현성 및 강건성을 검증했으며 일치율 100%을 보고했습니다. 이 테스트는 SLC6A4 프로모터의 긴 형태와 짧은 형태를 감지합니다. FDA는 3상에서의 이 테스트 사용이 비유의적 위험(NSR)이며 IDE가 필요하지 않다고 확인했습니다. AG+ 바이오마커는 인구의 약 14%에 존재합니다. Adial은 또한 AD04에 대한 새로운 특허 출원을 했으며 독점권을 2045년까지 연장할 것으로 예상됩니다.
Adial Pharmaceuticals (NASDAQ: ADIL) a annoncé l’achèvement de la validation analytique d’une méthode de collecte par écouvillon des joues et d’un test génétique associé développé avec Genomind pour identifier des SNP sérotoninergiques (HTR3A, HTR3B, SLC6A4) à des fins cliniques AD04 et pour une utilisation commerciale future.
Genomind a validé l’exactitude, la reproductibilité et la robustesse sur des échantillons et opérateurs variés, rapportant une concordance de 100%. Le test détecte les formes promotrices longues et courtes de SLC6A4. La FDA a confirmé que l’utilisation du test en phase 3 est considérée comme Risque Non Significatif (NSR) et qu’un IDE n’est pas requis. Le biomarqueur AG+ est présent chez environ 14% de la population. Adial a également mentionné un nouveau dépôt de brevet pour AD04, qui devrait étendre l’exclusivité jusqu’en 2045.
Adial Pharmaceuticals (NASDAQ: ADIL) gab bekannt, dass die analytische Validierung für eine Wangenabstrich-Entnahmemethode und den begleitenden Gentest, der gemeinsam mit Genomind entwickelt wurde, abgeschlossen wurde, um serotoninergene SNPs (HTR3A, HTR3B, SLC6A4) für die klinische Anwendung AD04 und künftig kommerzielle Nutzung zu identifizieren.
Genomind hat Genauigkeit, Reproduzierbarkeit und Robustheit über verschiedene Proben und Bediener hinweg validiert und berichtete eine 100%-ige Kongruenz. Der Test erkennt lange/kurze Promotorformen von SLC6A4. Die FDA bestätigte, dass die Verwendung des Tests in Phase 3 Nicht signifikantes Risiko (NSR) ist und kein IDE erforderlich ist. Der AG+ Biomarker ist in ca. 14% der Bevölkerung vorhanden. Adial wies außerdem auf eine neue Patentanmeldung für AD04 hin, die die Exklusivität voraussichtlich bis 2045 verlängern wird.
Adial Pharmaceuticals (NASDAQ: ADIL) أعلنت اكتمال التحقق التحليلي لطريقة جمع باستخدام مسحة خدٍّ وجين اختباري مرافق طورته مع Genomind لتحديد SNPs سيروتونيرجية (HTR3A, HTR3B, SLC6A4) للاستخدام السريري AD04 والاستخدام التجاري المستقبلي.
قامت Genomind بالتحقق من الدقة وإعادة الإنتاج والصلابة عبر عينات ومشغّلين مختلفين، مبينة التوافق المطابق 100%. الاختبار يكشف أشكال مُوَسِّعات SLC6A4 الطويلة/القصيرة. أكدت FDA أن استخدام الاختبار في المرحلة 3 عديم الخطر غير الهام (NSR) وليس هناك حاجة لـ IDE. وجود علامة AG+ في نحو 14% من السكان. كما أشارت Adial إلى تقديم براءة اختراع جديدة لـ AD04 مع توقع أن تمتد الحصرية حتى 2045.
Adial Pharmaceuticals (NASDAQ: ADIL)宣布完成对通过腮部拭子采集的方法及与 Genomind 共同开发的伴随基因检测的分析验证，以识别用于 AD04 临床及未来商业用途的血清素能 SNP（HTR3A、HTR3B、SLC6A4）。
Genomind 已在多样化样本和操作人员之间验证了准确性、重现性和鲁棒性，报告了100% 一致性。该测试可检测 SLC6A4 启动子长型/短型形式。FDA 确认该测试在第3阶段的使用为非显著性风险（NSR），不需要 IDE。AG+ 生物标记在大约14%的人群中存在。Adial 还提到 AD04 的新专利申请，预计将把独占权延长至2045年。
- Analytical validation completed for cheek swab SNP test
- Assay showed 100% concordance across SNP testing
- FDA classified Phase 3 use as Non‑Significant Risk (no IDE required)
- Biomarker (AG+) prevalence ~14% enabling targeted enrollment
- New patent filing expected to extend exclusivity to 2045
- AG+ biomarker targets only ~14% of the population, limiting addressable treated patients
Insights
Analytically validated cheek swab and FDA EOP2 alignment de-risk AD04's Phase 3 and future companion diagnostic commercialization.
Adial secured analytical validation with Genomind for SNPs in HTR3A, HTR3B, and SLC6A4, plus long/short SLC6A4 promoter forms, demonstrating 100% concordance across tested SNPs and validation for accuracy, reproducibility, and robustness.
Regulatory risk lowered: FDA labeled the test use in Phase 3 as Non‑Significant Risk, so no IDE filing is required; this supports using the assay within the upcoming registrational program. Operational risks remain around consistent real‑world specimen collection, lab throughput, and maintaining concordance across diverse sample sources.
Concrete items to watch: progression to a defined Phase 3 start window and protocol details, ongoing assay performance in prospective samples, and commercialization steps tied to the claimed patent extension to
Partnership has successfully completed analytical validation of a cheek swab collection solution for testing and identifying patients with the genotypes important for AD04 development
GLEN ALLEN, Va., Oct. 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, today announced the successful completion of the analytical validation of a cheek swab collection method for testing patients for both clinical trial usage as well as future commercial application. This major step marks a key milestone in advancing AD04 toward Food & Drug Administration (FDA) registration.
The objective of the partnership was to develop an analytically validated gene test in a CLIA-certified laboratory that would identify the important SNPs (single nucleotide polymorphisms) of the serotonergic system used for identifying patients for the upcoming Phase 3 program for AD04. This would serve as the starting point for development of a commercial companion diagnostic test for which a cheek swab specimen can be easily collected in a physician's office or at home.
Key Highlights from the Collaboration with Genomind:
- Through the collaboration with Genomind, Adial can now test SNPs in the HTR3A, HTR3B, and SLC6A4 gene.
- Additionally, Adial can test long and short forms of the SLC6A4 promoter.
- Genomind validated the assay for accuracy, reproducibility, and robustness utilizing commercially sourced human samples.
- Genomind’s validation process included a multitude of parameters such as inter- and intra-assay precision, diverse sample origins and ethnic backgrounds, operators, instruments, and assay reagent lots.
- The assay developed by Adial with the expertise of Genomind demonstrated
100% concordance across all SNP testing.
Adial is implementing FDA recommendations consistent with the recent End of Phase 2 (EOP2) meeting with the FDA, while ensuring its readiness to advance towards registrational Phase 3 development. The AD04 program is designed to support and accelerate commercial activities following registration and approval, for patients who are biomarker positive for AG+, a subset of the Alcohol Use Disorder (AUD) population, identified through Adial’s proprietary genetic test development in collaboration with Genomind. The AG+ biomarker is present in roughly
“We continue to make progress in preparation for the next phase of Adial’s journey,” commented Cary Claiborne, CEO of Adial. “Successful completion of the first phase of our partnership with Genomind, and the creation of this patient and physician-friendly test in the form of a cheek swab collection method, will play an important role in both the upcoming clinical program for AD04 as well as future commercial deployment. The ease of the test collection method allows for seamless identification of patients best suited to AD04 therapy, through a precision health platform designed with the patient in mind. A simple cheek swab test kit will assist in future commercial strategies for both physician led promotion as well as at home sample collection. The simplicity allows for testing and results to be reported within a few days. With regulatory alignment on key protocol elements, including patient population, efficacy endpoints, biomarker stratification, and adaptive enrichment strategies—we are now positioned to advance a streamlined and scientifically rigorous program designed to maximize the probability of success.”
“This milestone also demonstrates our commitment to precision medicine. By integrating pharmacogenetic insights and validated biomarkers into our development strategy, we are enhancing clinical predictability and believe we have set a new benchmark for targeted therapeutics in neuropsychiatry. This progress, coupled with the recent announcement of our new patent filing for AD04, expected to extend market exclusivity to 2045, frames the AD04 program as an extremely attractive future commercial opportunity with a meaningful patient impact. We remain focused on delivering a transformative solution for patients living with AUD.”
“As we advance toward Phase 3, we believe we are executing from a position of strength across regulatory, clinical, and manufacturing fronts. This is also a key element in our strategy to secure strategic partners who have indicated the importance of a simple solution to testing with an easy-to-execute SNP biomarker test. Through disciplined execution, we believe AD04 is positioned to become the first genetically targeted therapy for AUD—addressing a large, underserved patient population and unlocking a highly attractive commercial opportunity,” concluded Mr. Claiborne.
About Genomind
Genomind is at the forefront of personalized medicine, empowering healthcare providers with cutting-edge pharmacogenetic testing that informs medication decisions based on a patient’s unique genetic profile. Genomind optimizes medication management, improving outcomes for patients and enhancing collaboration between patients and healthcare providers.
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 advancing AD04 toward registration, developing a commercial companion diagnostic test for collecting a cheek swab specimen in a physician's office or at home, implementing FDA recommendations consistent with the recent EOP2 meeting with the FDA, ensuring the Company’s readiness to advance toward registrational Phase 3 development, designing the AD04 program to support and accelerate commercial activities following registration and approval for patients who are biomarker positive for AG+, continuing to make progress in preparation for the next phase of Adial’s journey, successful completion of the first phase of the Company’s partnership with Genomind and the creation of the patient and physician-friendly test in the form of a cheek swab collection method playing an important role in both the upcoming clinical program for AD04 as well as future commercial deployment, being positioned to advance a streamlined and scientifically rigorous program designed to maximize the probability of success with regulatory alignment on key protocol elements, enhancing clinical predictability and setting a new benchmark for targeted therapeutics in neuropsychiatry by integrating pharmacogenetic insights and validated biomarkers into the Company’s development strategy, extending market exclusivity to 2045 with the new patent filing for AD04, the AD04 program being an extremely attractive future commercial opportunity with a meaningful patient impact, remaining focused on delivering a transformative solution for patients living with AUD, executing from a position of strength across regulatory, clinical, and manufacturing fronts as the Company advances toward Phase 3, the Company’s strategy to secure strategic partners, AD04 being positioned to become the first genetically targeted therapy for AUD, addressing a large, underserved patient population and unlocking a highly attractive commercial opportunity 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 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, 2024, 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
Contact:
Genomind, Inc.
Daniel Dowd
Tel: 877-895-8658
Email: ddowd@genomind.com
FAQ
What did Adial announce on October 9, 2025 about the AD04 companion test (ADIL)?
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