EXCLUSIVE: Adial Pharmaceuticals Lead Candidate For Alcohol Use Disorder Advances Toward Phase 3 Trial

Adial Pharmaceuticals, Inc. ADIL on Wednesday announced progress in the design and planning of its upcoming Phase 3 trial evaluating AD04, the company's lead investigational genetically targeted, serotonin-3 receptor antagonist, a therapeutic agent for Alcohol Use Disorder (AUD) in heavy drinking patients (defined as < 8 drinks/day).

As part of its Phase 3 trial preparation, Adial engaged Cytel Inc., a provider of data science and advanced statistical methodologies for clinical trials, to provide expert support on trial design and data interrogation.

Cytel's contributions have helped inform key design elements of Adial's upcoming trial, which aims to maximize efficiency, cost-effectiveness, and the likelihood of success.

Also Read: EXCLUSIVE: After FDA Response, Adial Starts Manufacturing Clinical Supplies For Upcoming Phase 3 Program Of Lead Candidate For Alcohol Use Disorder

In part, Cytel's efforts identified specific genetic subpopulations potentially more responsive to AD04, enabling a refined Phase 3 strategy that aligns with clinical and regulatory expectations.

Highlights:

Post-hoc historical clinical trial data analyses identified genotype-defined patient subgroups likely to benefit most from AD04. This supports Adial's precision medicine approach in the upcoming Phase 3 trial, which targets higher efficacy and commercial differentiation.

Adial partnered with Cytel to apply advanced statistical analytics and simulation modeling to optimize the trial design, enable adaptive enrichment, and align with regulatory expectations.

The Phase 3 trial is expected to begin in late 2025, with the potential for interim analysis-driven readouts supporting a streamlined path to potential regulatory submission.

Why It Matters

Adial said in a statement on Wednesday that AD04 represents a first-in-class opportunity in the multi-billion-dollar global AUD market and that its refined clinical strategy will accelerate value realization.

In May, the U.S. Food and Drug Administration (FDA) granted the company's request for an End of Phase 2 meeting to discuss its proposed clinical development plan and seek the U.S. Food and Drug Administration (FDA) guidance on the Phase 3 trial for AD04. The meeting will take place on July 25, 2025.

The United States Patent and Trademark Office (USPTO) issued patent number 12,274,692 to AD04 in May.

The patent covers a method of treating alcohol-related diseases and opioid-related disorders using AD04 in genetically identified patients.

Price Action: ADIL stock closed at $0.59 on Tuesday.

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