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Adial Pharmaceuticals Advances Toward Phase 3 Development for AD04
Globenewswire· 2025-06-11 12:00
Core Insights - Adial Pharmaceuticals is advancing its Phase 3 trial for AD04, a treatment for Alcohol Use Disorder (AUD), with the support of Cytel's machine learning technology for data analysis and trial design [1][2][4] Group 1: Trial Design and Strategy - The collaboration with Cytel aims to enhance trial design efficiency, cost-effectiveness, and success likelihood by identifying genetic subpopulations that may respond better to AD04 [2][4][7] - Adial's precision medicine approach focuses on targeting specific patient subgroups to improve efficacy and commercial differentiation in the upcoming trial [7][8] Group 2: Market Potential and Product Overview - AD04 is positioned as a first-in-class opportunity in the multi-billion-dollar global AUD market, with potential applications for other addictive disorders such as Opioid Use Disorder, gambling, and obesity [4][5][8] - The ONWARD™ pivotal Phase 3 clinical trial previously showed promising results in reducing drinking among heavy drinking patients without significant safety concerns [5][8] Group 3: Upcoming Milestones - The precision-focused Phase 3 trial is expected to commence in late 2025, with possibilities for interim analysis-driven readouts to facilitate regulatory submission [7][8]