Adial Pharmaceuticals Announces Collaboration Agreement with Eurofins for Genetic Biomarker Testing to Support Upcoming Phase 3 Clinical Trial for Alcohol Use Disorder
CHARLOTTESVILLE, VA / ACCESSWIRE / May 7, 2019 / Adial 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.
About Adial Pharmaceuticals, Inc.
Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of treatments for addictions. The Company's lead investigational new drug product, AD04, is a genetically targeted therapeutic agent for the treatment of Alcohol Use Disorder ("AUD"). A Phase 2b clinical trial of AD04 for the treatment of AUD showed promising results in reducing frequency of drinking, quantity of drinking and heavy drinking (all with statistical significance), and no overt safety concerns (there were no statistically significant serious adverse events reported). The Company plans to commence a Phase 3 clinical trial using AD04 for the potential treatment of AUD in subjects with certain target genotypes, which are to be identified using the Company's proprietary companion diagnostic genetic test. AD04 is also believed to have the potential to treat other addictive disorders such as opioid use disorder, gambling, and obesity. www.adialpharma.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 our companion diagnostic genetic test allowing us to only enroll patients that have the genetics making them likely to respond to AD04, the efficacy rates of AD04 in clinical trials being to dramatically enhanced and the time and cost needed to conduct the trials being reduced, the personalized approach of using genetics to identify patients likely to respond to treatment becoming more prevalent in the coming years for the treatment of a variety of diseases and disorders, commencement of the planned Phase 3 clinical trial using AD04 for the potential treatment of AUD in subjects with certain genotypes and , the potential of AD04 to treat AUD and 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, the ability to use the companion diagnostic genetic test to only enroll patients that have the genetics making them likely to respond to AD04, our ability to dramatically enhance the efficacy rates of AD04 in clinical trials and the reduce time and cost needed to conduct the trials being reduced as a result of the genetic testing, using genetics to identify patients likely to respond to treatment becoming more prevalent for the treatment of a variety of diseases and disorders, our ability to commence the Phase 3 clinical trials as expected, the ability to expand the use of AD04 for use in patients with opioid use disorder, gambling and obesity, the ability of AD04 therapy to perform as designed, to demonstrate safety and efficacy, as well as results that are consistent with prior results, the ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, our ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to our ability to promote or commercialize our product candidates for specific indications, acceptance of its product candidates in the marketplace and the successful development, marketing or sale of products, our ability to maintain our license agreements, the continued maintenance and growth of our patent estate, our ability to establish and maintain collaborations, our ability to obtain or maintain the capital or grants necessary to fund its research and development activities, 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, 2018. 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.
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SOURCE: Adial Pharmaceuticals, Inc.
Released May 7, 2019