Adial Pharmaceuticals Announces Positive Clinical Study Results from the AD04-103 Pharmacokinetics Study of AD04 for the Treatment of Alcohol Use Disorder

Core Viewpoint - Adial Pharmaceuticals has completed a pharmacokinetics study of its investigational drug AD04, which is aimed at treating Alcohol Use Disorder (AUD) and is preparing for FDA approval under the 505(b)(2) regulatory pathway [1][4]. Group 1: Study Results - The pharmacokinetics study (AD04-103) evaluated the bioavailability and food effect of AD04 near-micro doses compared to marketed ondansetron in healthy volunteers, enrolling a total of 30 participants [2][8]. - Results indicated that ondansetron pharmacokinetic exposure increased proportionally across a three-fold AD04 dose range, confirming that AD04 can be taken with or without food [3][8]. - The study supports a near micro-dosing regimen for AD04, aligning with FDA's bridging requirements for the upcoming registration trials [1][4]. Group 2: Drug Mechanism and Target Population - AD04, a selective serotonin-3 receptor antagonist, is designed to reduce alcohol craving and is distinct yet complementary to existing AUD therapies [5][7]. - The drug targets patients with specific 5-HT3 genomic biomarkers, particularly those with mutations in the 5HT3 receptor, which may lead to significant reductions in alcohol consumption [5][6]. Group 3: Future Plans and Regulatory Engagement - The successful completion of the bridging study allows the company to engage with the FDA regarding the design of the Phase 3 program and prepare for an End-of-Phase 2 meeting in the first half of the year [1][4]. - Adial has developed a companion diagnostic test to identify patients who may benefit from AD04, which will be utilized in future clinical studies to support FDA approval and commercial availability [6][9].