Cary Claiborne, CEO of Adial Pharmaceuticals, commented, "We continue to achieve meaningful milestones on our path toward U.S. Food and Drug Administration (FDA) approval and eventual commercialization of AD04, our lead investigational drug, a serotonin-3 receptor antagonist being developed for the treatment of Alcohol Use Disorder (AUD). A key highlight of our recent progress was the successful End of Phase 2 (EOP2) meeting with the FDA, where we received valuable guidance on critical elements of our planned adaptive Phase 3 study design, including the target population, clinical endpoints, inclusion and exclusion criteria, dosing regimen, and validation of both biomarker-positive and biomarker-negative groups."
"We are now implementing the FDA's recommendations based on this meeting, positioning us to advance confidently toward registrational Phase 3 development. The AD04 program aims to deliver targeted and commercially focused success following approval, specifically for patients who are biomarker-positive for AG+, a subset of the AUD population identified through our proprietary genetic test. The AG+ biomarker is found in approximately 14% of the general population, as supported by large-scale epidemiological studies and previous AD04 clinical trial data."
"We are also encouraged by recent U.S. Senate support for expanding clinical trial endpoints beyond abstinence in evaluating treatments for Alcohol and Substance Use Disorders. The bipartisan Appropriations Committee's recommendation for the FDA and the National Institute on Drug Abuse (NIDA) to consider additional measures, such as reduced cravings, decreased use, and lowered disorder severity, strongly reinforces our therapeutic approach and patient-centered philosophy. Our AD04 program has always focused on reducing alcohol consumption and cravings rather than enforcing an all-or-nothing abstinence model, and it is encouraging to see legislative recognition of the need for more realistic and compassionate treatment outcomes. This forward-looking perspective aligns with the core of our development strategy and further validates our belief that AD04 is uniquely positioned to benefit from this evolving regulatory environment."
"To further support these efforts, we have partnered with Genomind to develop our precision medicine testing solution. Together, we have completed the analytical validation of a cheek swab collection method to identify eligible patients, a critical step for both clinical trial implementation and future commercial use. This achievement represents a major milestone in our journey toward FDA approval and lays the groundwork for a commercial companion diagnostic test that can be easily performed in a physician's office or at home. During our recent EOP2 meeting, the FDA also confirmed that use of this test in the Phase 3 study represents a Non-Significant Risk (NSR), meaning an Investigational Device Exemption (IDE) application is not ...
