Adial Pharmaceuticals Receives Notice of Allowance of Additional Patent for the Treatment of Alcohol Use Disorder with AD04 in Patients Identified Using a Molecular Genetic Biomarker

Adial Pharmaceuticals, Inc. (NASDAQ:ADIL; ADILW), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that it has received a Notice of Allowance for the issuance of a patent by the United States Patent and Trademark Office (USPTO), titled: "Serotonin Transporter Gene and Treatment of Alcoholism." This patent addresses a method of treating alcohol use disorder (AUD) in patients with a specific genetic biomarker in the serotonin transporter gene by administering the Company's investigational new drug product, AD04, a 5-HT3 antagonist, to patients with the TT genotype. This patent builds upon a previous Company patent for patients with the LL/TT genotype.

The genetic biomarker is part of the genetic panel used to identify patients expected to respond to treatment with AD04. As previously announced, Adial recently completed the validation of its proprietary genetic test through its partnership with Eurofins Biopharma Services. This test will be used to identify potential subjects for inclusion in the planned Phase 3 trial of AD04 as a treatment for AUD in biomarker positive subjects.

William Stilley, Chief Executive Officer of Adial Pharmaceuticals, commented, "We continue to aggressively build our patent estate around AD04. This is the second Notice of Allowance by the USPTO in the same patent family targeting patients with specific biomarkers in the serotonin transporter gene. This marks another important milestone as we progress towards commencing our Phase 3 trial of AD04. By targeting specific genotypes, we believe that we have uniquely positioned AD04 as a potential best-in-class therapy for the treatment of alcohol use disorder, and our patent strategy is to develop the broadest patent protection possible by filing multiple patents within the same patent domain to make it more difficult for potential future competitors."

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. 

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