Adial Pharmaceuticals Plans to Enter Genetic Testing Market Following Allowance of U.S. Patent for Genetic Diagnostic Test

The Company believes the genetic companion diagnostic test for AD04 for Alcohol Use Disorder represents a multi-billion dollar potential market opportunity

CHARLOTTESVILLE, Va., June 22, 2021 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today announced plans to enter the genetic testing market after it received a Notice of Allowance from the U.S. Patent and Trademark Office related to use of the Company’s genetic diagnostic panel in combination with the Company’s lead product, AD04, for the treatment of Alcohol Use Disorder (AUD). The patent covered by the Notice of Allowance also pertains to the Company’s use of its genetic diagnostic panel in combination with AD04 for the treatment of Opioid Use Disorder (OUD).

“This new patent related to the use of our genetic diagnostic panel in combination with AD04 for the treatment of AUD and OUD is a major milestone as we believe genetic evaluation of patients can be used to identify individuals that may benefit from AD04. We have been utilizing the genetic panel covered by this patent in our ongoing ONWARD Phase 3 trial, and, given this patent allowance, we anticipate that genetic diagnostics are expected to be an important segment of our commercial strategy going forward,” said William Stilley, Chief Executive Officer of Adial Pharmaceuticals. “Our view that AUD has a solid nexus in genetics is fundamental to the premise of the successful Phase 2B trial of AD04 conducted at the University of Virginia and our ONWARD Phase 3 trial of AD04 currently underway in Europe. And, it is consistent with Adial’s premise that the presence of certain genetics is expected to substantially influence whether an individual suffering from AUD or OUD would likely respond to treatment with AD04.”

The recently allowed patent, once issued, is expected to provide market exclusivity for the AD04 genetic diagnostic test, creating a possibly significant profit center for the Company. Therefore, assuming approval by either the U.S. or European regulatory authorities, Adial plans to enter the genetic testing market as a stand-alone commercial business line and develop and market the genetic diagnostic panel as a Companion Diagnostic Test to AD04 for identification of the approximately one-third (33%) of AUD patients expected to respond to treatment with AD04. The Company also sees a future opportunity to commercialize a companion diagnostic test to AD04 for OUD, if an OUD approval is also received for AD04.