Adial Pharmaceuticals Provides Business Update Following Favorable Comments from FDA End-of-Phase 2 (EOP2) Meeting for AD04

Core Insights - Adial Pharmaceuticals has received positive feedback from the FDA regarding the Phase 3 clinical trial design for its lead drug AD04, aimed at treating Alcohol Use Disorder (AUD) [1][5][6] - The FDA's input is seen as a significant milestone that enhances the clinical and statistical framework for the upcoming trial, positioning the company for potential commercial success [4][5][7] FDA Meeting Outcomes - The EOP2 Meeting aimed to align on the design of the Phase 3 clinical development program for AD04, a serotonin-3 receptor antagonist targeting individuals with heavy drinking and specific genotypes [2][6] - Key elements discussed included target population, clinical endpoints, inclusion/exclusion criteria, dosing regimen, and biomarker stratification [2][6] - The FDA confirmed primary efficacy endpoints, specifically targeting zero heavy drinking days during months 5 and 6 of the observation period [6] Development Strategy - Adial is implementing FDA recommendations to ensure readiness for registrational Phase 3 development, focusing on patients who are biomarker positive for AG+, which represents about 14% of the general population [4][6] - The company emphasizes a commitment to precision medicine by integrating pharmacogenetic insights and validated biomarkers into its development strategy [5][6] Commercial Potential - The recent patent filing for AD04 may extend market exclusivity to 2045, framing the program as a highly attractive commercial opportunity [5][6] - The company aims to address a large, underserved patient population, potentially becoming the first genetically targeted therapy for AUD [7]