Adial Pharmaceuticals Announces Database Lock in Pharmacokinetics Study of AD04 for the Treatment of Alcohol Use Disorder

Core Viewpoint - Adial Pharmaceuticals has announced the database lock for its pharmacokinetics study of AD04, a treatment for Alcohol Use Disorder, with topline results expected in Q4 2024 [1][2]. Company Overview - Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing therapies for addiction and related disorders [3]. - The lead investigational drug, AD04, is a genetically targeted serotonin-3 receptor antagonist aimed at treating Alcohol Use Disorder in heavy drinking patients [3]. - AD04 has shown promising results in the ONWARD™ pivotal Phase 3 clinical trial, demonstrating effectiveness in reducing drinking without significant safety concerns [3]. Study Details - The pharmacokinetics study was a single-center open-label trial that enrolled 30 healthy adult volunteers [2]. - The study compared the pharmacokinetic profile of AD04 at an oral dose of 0.33 mg, with or without food, against a reference standard product [2]. Future Plans - The company is preparing for the release of topline results and plans to re-engage with the FDA, with insights from the study expected to shape the clinical strategy for the Phase 3 study [2]. - The topline results are anticipated to strengthen the company's position for potential strategic collaborations in future clinical development of AD04 [2].