Adial Pharmaceuticals, Inc. (NASDAQ:ADIL) on Tuesday received the final meeting minutes from its End of Phase 2 (EOP2) Meeting with the U.S. Food and Drug Administration (FDA) held in July.
The minutes provide the FDA's formal input into the AD04 Phase 3 adaptive clinical trial design and broader clinical development strategy.
The objective for the EOP2 Meeting was to align with the FDA on the design of the Phase 3 clinical development program for AD04, the company's lead investigational drug, a serotonin-3 receptor antagonist, being developed for the treatment of Alcohol Use Disorder (AUD) in individuals with heavy drinking and select genotypes.
Key Highlights from the FDA EOP2 Meeting:
FDA supported Adial's protocol and proposed core elements for the adaptive trial design.
The agency confirmed the proposed primary efficacy endpoints for AD04, specifically, zero heavy drinking days during months 5 and 6 of the efficacy observation period.
FDA advised that key secondary endpoints intended for future product labeling should be pre-specified in the protocol for consideration.
The FDA supported Adial's plan to account for homozygous populations and referenced guidance on developing targeted therapies for low-frequency molecular subsets, with implications for study design and potential labeling of rare subgroups.
The FDA provided feedback on the planned interim analyses, Statistical Analysis Plan (SAP), and Data Monitoring Committee (DMC) structure.
Adial is implementing FDA recommendations consistent with the meeting outcomes, ensuring its readiness to advance toward registrational Phase 3 development.
Price Action: ADIL stock is up 7.86% at $0.38 during the premarket session at the last check on Tuesday.
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