Adial Pharmaceuticals Doses Last Patient In Critical AD04 Pharmacokinetics Study

Adial Pharmaceuticals, Inc., a biopharmaceutical firm in the clinical stage dedicated to creating treatments for addiction and associated disorders, has revealed that the final patient has finished their last dose in the pharmacokinetics study for AD04. This investigational therapeutic agent, a genetically targeted serotonin-3 receptor antagonist, is designed to treat Alcohol Use Disorder (AUD) in heavy drinkers (defined as fewer than 10 drinks per day). The company anticipates sharing the top-line results from both study cohorts in the fourth quarter of 2024.

Cary Claiborne, President and Chief Executive Officer of Adial, remarked “Completion of dosing in the pharmacokinetics study for AD04 marks a significant milestone in our path toward initiating the Phase 3 clinical trial. This trial is intended to optimize dosing and, in turn, maximize the efficacy and safety of AD04 in patients with AUD. This achievement emphasizes our commitment to advancing AD04 and maximizing its likelihood of success, as a promising treatment for AUD. We believe this trial data will also play a key role as we advance ongoing partnership discussions.”

He further added, “Our immediate focus will now shift to a thorough review of the important pharmacokinetic data gathered from this study. We are eager to analyze the insights and integrate them into our comprehensive development plan. Following the receipt of the topline results, which we anticipate in the fourth quarter, we will engage in detailed discussions with the FDA to ensure our path forward is well-aligned with regulatory expectations.”

A single-center, open-label study assessing relative bioavailability and dose proportionality has been conducted with 30 healthy adult participants. This study will evaluate the pharmacokinetic profile of AD04 administered as an oral dose of 0.33 mg, both with and without food, in comparison to a reference standard product.