GLEN ALLEN, Va., May 15, 2024 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ:ADIL) ("Adial" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today provided a business update and reported its financial results for the first quarter of 2024. Cary Claiborne, President and Chief Executive Officer of Adial, stated, "We are making steady progress as it relates to AD04. We have initiated new activities related to our clinical development plan after incorporating favorable feedback received from the FDA last year. We anticipate conducting two parallel Phase 3 clinical trials of AD04 to support potential approval in the shortest timeframe possible while minimizing risk. To support our efforts, we formally hired Tony Goodman as our Chief Operating Officer during the quarter. Given his impressive background as an accomplished pharmaceutical industry executive, as well as serving on our Board of Directors since 2017, he has played a key role in advancing our strategic growth initiatives, including clinical development and commercial planning for AD04, while also furthering partnership discussions." "In addition, we are committed to developing a robust patent estate around AD04 and have been awarded key patents from the United States Patent and Trademark Office in 2024. First, we were awarded patent number 11,905,562, which further protects AD04 and covers its unique ability to target the serotonin transporter gene for the potential treatment of opioid use disorder (OUD). More recently, we were issued patent number 11,957,664, which covers important aspects of the combination of our proprietary genetic diagnostic and AD04 to treat alcohol use disorder (AUD), OUD, and other drug dependencies. These patents are important given our post hoc analysis identified genotypes that positively responded to AD04, which represents an addressable market of approximately $40 billion in the U.S. alone. Additionally, these patents enable us to expand our focus on AUD in the future, including advancing AD04 for the potential treatment of OUD." "Overall, we believe we are well positioned to execute on meaningful milestones ahead, while having preserved a strong balance sheet. We look forward to updating our shareholders as developments unfold," concluded Mr. Claiborne. Other Developments Publications On April 10, 2024, Adial announced the publication of a peer-reviewed article highlighting the promising clinical results, strong safety profile and high compliance among patients administered AD04 (low-dose ondansetron), the Company's lead investigational new drug product being developed for the treatment of Alcohol Use Disorder (AUD). The publication also reported the results of a new study analyzing the liver safety profile of AD04 compared with placebo in subjects with AUD in the Company's prior Phase 3 clinical trial. The published study provides a comprehensive analysis of the liver safety profile of AD04 compared to a placebo in individuals with AUD and a specific 5-marker genetic profile. AUD, characterized by compulsive alcohol consumption and loss of ...