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Adial Pharmaceuticals Achieves Important Milestone of First Patient Dosed in Pharmacokinetics Study of AD04 for the Treatment of Alcohol Use Disorder
Study intended to optimize design elements needed for the upcoming US Pivotal Phase 3 studiesand support ongoing partnership discussions Topline results
About this update from Adial Pharmaceuticals, Inc
[{"type":"text","content":"Study intended to optimize design elements needed for the upcoming US Pivotal Phase 3 studiesand support ongoing partnership discussions Topline results expected in early Q4 2024 GLEN ALLEN, Va., June 05, 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 that the first patient has been dosed in a 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, “Dosing our first patient is an important milestone, marking the beginning of clinical activity in this previously planned and pre-budgeted study. Our goal is to obtain data we need to design a more precise and informed Phase 3 trial protocol, including evaluating the optimal dosing regimen to maximize the efficacy and safety of AD04 in patients with AUD. Completion of this study is in accord with previous guidance provided by the FDA and is intended to enhance the likelihood of success in our upcoming Phase 3 trial. This relatively short and low-cost study is also a key element of our strategy to advance ongoing partnership discussions. The study will also provide data necessary to support an application for approval of AD04 under a 505(b)(2) regulatory pathway with FDA. Looking ahead, we plan to engage with the FDA in Q4 2024 to discuss the results of this pharmacokinetics study and obtain feedback to refine the Phase 3 study design. This meeting will help establish the final protocol and ensure that it aligns with FDA expectations, further advancing AD04 towards regulatory approval.” The pharmacokinetics study will involve two cohorts conducted consecutively and is expected to be completed in early Q4 2024. The single-center, relative bioavailability, open-label study will enroll up to 30 healthy adult volunteers and compare the pharmacokinetic profile of AD04 when administered as an oral dose taken twice daily of 0.33 mg with or without food against a reference standard product. This study will provide valuable information on the pharmacokin...