Adial Pharmaceuticals Partners with Genomind for Precision Medicine Testing Solution

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 14% of the general population, as represented in large-scale epidemiology studies as well as the prior clinical study population from previous trials of AD04. During the recent EOP2 meeting, FDA confirmed that use of this test in the Phase 3 study was a Non-Significant Risk (NSR) and filing of an Investigational Device Exemption (IDE) application was not required.

"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: [email protected] 

Contact:

Genomind, Inc.

Daniel Dowd

Tel: 877-895-8658

Email: [email protected]