Adial Completes Validation of Genetic Biomarker Test in Collaboration with Eurofins for Upcoming Phase 3 Trial

Posted by Sandra Hageman on Dec 19, 2019 11:28:21 AM
Sandra Hageman

shutterstock_2389938 Biomarkers close-up

Eurofins BioPharma Services, Laboratory Testing is a full service global organization with dedicated testing facilities for Early Clinical Development, Central Laboratory Services, Bioanalytical Services, Virology and Immunology Testing Services, Anatomic Pathology and Genomics Services. With the largest network of dedicated biopharma laboratories in the world, we offer the most comprehensive testing in the industry. This network provides our Clients with access to scientists of all laboratory specializations within one organization and allows us to provide highly consultative services. With regard to any other clinical trial laboratories, Eurofins is unparalleled in its portfolio of testing, its innovative technology and its history of having a global presence.

We are pleased to share a press release issued by Adial Pharmaceuticals: Adial, a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that it has completed validation of its genetic biomarker test for the upcoming Phase 3 trial. The Phase 3 trial is designed to study AD04, a genetically targeted therapeutic agent for the treatment of Alcohol Use Disorder.

Eurofins Genomics (“Eurofins”), a division of Eurofins Biopharma Services, a global scientific leader in bioanalytical testing, performed the laboratory validation of Adial’s companion diagnostic genetic test using double strand Sanger sequencing and Fragment length analysis of polymerase chain reaction (PCR) products. These assays will be used for the analysis of patients’ blood samples for genetic variants in defined genes caused by Single Nucleotide Polymorphisms or Fragment Length Polymorphisms. The acceptability of the assay validation will be evaluated further by the local ethics committees and regulatory authorities during the clinical trial application (CTA) assessments.

William Stilley, Chief Executive Officer of Adial Pharmaceuticals, commented: “Completion of the genetic test validation is another important milestone as we finalize preparations for our Phase 3 trial. By genetically pre-screening patients prior to enrollment, our companion diagnostic genetic test should allow us to only enroll those patients that have the genetic biomarkers indicating that they are likely to respond to AD04. We believe this approach will enhance the efficacy rates of AD04 in the trial and reduce the time and costs associated with conducting the trial.”

Elena Logan, Senior VP, Eurofins Biopharma Services, noted: “The genetic test met or exceeded all the necessary criteria for use in the upcoming Phase 3 trial. Adial is at the forefront of precision medicine, developing a personalized approach using a genetic companion diagnostic test to identify patients likely to respond to treatment. We are delighted to support Adial in this important mission to advance AD04 as an attractive potential therapy addressing a significant unmet need among patients with Alcohol Use Disorder.”

For full press release, please click here.


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