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TextAdial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW) www.adialpharma.com, a clinical-stage biopharmaceutical company focused on the development of medicines for addiction, today announced that it has entered into a collaboration agreement with Eurofins Scientific (“Eurofins”), a global scientific leader in bioanalytical testing, to provide the genetic testing during Adial Pharmaceutical’s planned Phase 3 clinical trial (“Phase 3 Trial” or the “Trial”). The Phase 3 Trial is designed to study AD04, a genetically targeted therapeutic agent for the treatment of Alcohol Use Disorder.
Under the agreement, Eurofins will transfer the genetic test methodology into its facilities and perform the laboratory validation of the Company’s companion diagnostic genetic test using quantitative polymerase chain reaction (qPCR). Eurofins will then conduct the genetic testing of potential subjects prior to their enrollment in the Phase 3 Trial to determine if they have the genetic markers indicating they would be expected to respond to treatment with AD04. The test results will be used as inclusion/exclusion criteria, allowing only patients positive for the genetic marker to be enrolled in the Phase 3 Trial.
William Stilley, President and Chief Executive Officer of Adial Pharmaceuticals, stated, “We are pleased to partner with Eurofins for our planned Phase 3 Trial, as Eurofins is an established and well-respected market leader in the field of analytical testing. Our investigational product, AD04, uses a novel mode of action designed to reduce cravings for alcohol to effectively curb alcohol intake, without the requirement of abstinence prior to or during treatment. By genetically pre-screening patients prior to enrollment, our companion diagnostic genetic test should allow us to only enroll patients that have the genetic biomarkers indicating that they are likely to respond to AD04. This is expected to dramatically enhance the efficacy rates of AD04 in the Trial and reduce the time and cost needed to conduct the Trial. Eurofins is an ideal partner for performing the companion diagnostic genetic testing given their extensive experience with genotyping studies and broad geographic footprint.”
“Eurofins looks forward to a long relationship with Adial as they work to bring AD04 to the market to help those with Alcohol Use Disorder,” said Elena Logan, Senior VP, Eurofins Biopharma Services. “The precision medicine, personalized approach of using genetics companion diagnostic testing to identify patients likely to respond to treatment is expected to become prevalent in the coming years for the treatment of a variety of diseases and disorders. Eurofins is a leader in developing these technologies and is excited to work with Adial to progress their genetically targeted drug, AD04.”
About Eurofins Scientific
Eurofins Scientific is a market leader in testing and laboratory services for genomics, discovery pharmacology, forensics, manufacturing processes, and advanced material sciences. With 45,000 staff in over 800 laboratories across 47 countries, Eurofins offers a portfolio of over 200,000 analytical methods for evaluating the safety, identity, composition, authenticity, origin and purity of biological substances and products, as well as clinical diagnostics.
About Eurofins BioPharma Services
Reliable, high quality laboratory data is pivotal to the success of clinical trials. Since laboratory testing is our sole focus, we go above and beyond to provide an array of services to ensure that any clinical trial sample is collected, transported, managed, analyzed, reported and stored to meet the objectives and purpose of your study. We are dedicated to providing the most cost effective and efficient solutions to pharmaceutical, biotech companies and CROs alike.
Eurofins BioPharma Services supports our customers with Central Laboratory (U.S., Netherlands, Singapore, China), Large and Small Bioanalytical (U.S., U.K., France), Phase 1/Early Development (France) and Immunology/Virology (U.S.) specialization laboratories globally. This provides our client base with true end-to-end laboratory solutions for your entire clinical phase development activity.