GLEN ALLEN, Va., Aug. 14, 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 second quarter of 2024. Cary Claiborne, President and Chief Executive Officer of Adial, stated, "I'm proud of the important progress we have made during the second quarter of 2024 in advancing AD04, our lead investigational genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD). In June we initiated a pharmacokinetics study of AD04. The final patient completed dosing in the second cohort in August, marking a significant milestone for us. We expect to report topline results from the study during the fourth quarter of 2024. Completion of this study will satisfy a key requirement of the FDA guidance we received as well as inform the study design for the planned Phase 3 clinical trial of AD04. We believe that this will position us more favorably in our ongoing conversations with potential partners." The single-center open-label relative bioavailability and dose proportionality study enrolled 30 healthy adult volunteers and will compare the pharmacokinetic profile of AD04 when administered as an oral dose of 0.33 mg, with or without food, against a reference standard product. "Furthermore, we entered into a collaboration agreement with Boudicca Dx, a global precision medicine testing accelerator, who will support and advise on the development plan of our companion diagnostic genetic test (CDx) to help ensure compliance with FDA guidelines. Receiving input from the FDA on our CDx plan for the US will assist in clinical success as well as in our next interaction with the FDA on our Phase 3 trial. Overall, we are taking the essential measures to provide us with the greatest probability of success during the Phase 3 trial. We look forward to reporting the pharmacokinetic study results during the fourth quarter and swiftly commencing our Phase 3 trial of AD04," concluded Mr. Claiborne. Other Developments Patents On July 31, 2024, Adial announced filing a new patent application to protect core assets and extend intellectual property on core technologies to 2044. Publications On June 20, 2024, Adial announced the publication of a leading peer-reviewed journal supporting the potential efficacy of AD04 as a precision medicine for the treatment of AUD. The publication findings showed a significant difference in the monthly percentage of heavy drinking days between the Company's lead asset, AD04 (low-dose ondansetron), and the placebo group among heavy drinking patients with Alcohol Use Disorder (AUD) and specific genotypic variants. The publication is available via Open Access at: https://www.ejinme.com/article/S0953-6205(24)00240-1/fulltext On April 10, 2024, ...