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Adial Pharmaceuticals Advances to Second Cohort in Pharmacokinetics Study of AD04 for the Treatment of Alcohol Use Disorder
Patient dosing in the second cohort has commenced following the successful completion of the first cohort GLEN ALLEN, Va., July 23, 2024 (GLOBE NEWSWIRE) --
About this update from Adial Pharmaceuticals, Inc
[{"type":"text","content":"Patient dosing in the second cohort has commenced following the successful completion of the first cohort\nGLEN ALLEN, Va., July 23, 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, announced the progression to the second cohort in the pharmacokinetics study of AD04, the Company’s lead investigational genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients (defined as Cary Claiborne, President and Chief Executive Officer of Adial commented, “We are pleased with the progress of our pharmacokinetics study of AD04. The successful completion of the first cohort allows us to advance to the second cohort as planned, staying on track with our projected timeline. The results from both cohorts will offer invaluable insights that are critical for the design of our upcoming Phase 3 Clinical Trial. We anticipate engaging with the FDA following receipt of the topline data from this study and seek their feedback on the overall design of our Phase 3 program.” The pharmacokinetics study was initiated in June 2024 and is expected to be completed during the fourth quarter of 2024. The single-center open-label relative bioavailability and dose proportionality study will enroll up to 30 healthy adult volunteers and 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. This study will provide valuable information on the pharmacokinetic properties of AD04. About Adial Pharmaceuticals, Inc. Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of treatments for addictions and related disorders. The Company’s lead investigational new drug product, AD04, is a genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients and was recently investigated in the Company’s ONWARD™ pivotal Phase 3 clinical trial for the potential treatment of AUD in subjects with certain target genotypes identified using the Company’s companion diagnostic genetic test. ONWARD showed ...