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Adial Pharmaceuticals advances toward Phase 3 development for AD04

Adial Pharmaceuticals (ADIL) announced progress in the design and planning of its upcoming Phase 3 trial evaluating AD04, its lead investigational therapy for Alcohol Use Disorder. Highlights: Precision Phase 3 Planning: Post-hoc analyses of historical clinical trial data identified genotype-defined patient subgroups likely to benefit most from AD04. This supports Adial’s precision medicine approach in the upcoming Phase 3 trial-targeting higher efficacy and commercial differentiation. Data-Driven, Adaptive Trial Design: Adial partnered with Cytel to apply advanced statistical analytics and simulation modelling to support a more efficient and targeted Phase 3 strategy, including machine learning and proprietary tools such as East to optimize the trial design, enable adaptive enrichment, and align with regulatory expectations. Upcoming Milestones: The precision-focused Phase 3 trial is expected to begin in late 2025, with potential for interim analysis-driven readouts, supporting a streamlined path to potential regulatory submission.

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