Adial Pharmaceuticals, Inc., 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.
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