Adial Pharmaceuticals Completes Dosing in AD04 Alcohol Use Disorder Study

Adial Pharmaceuticals, Inc., a clinical-stage biopharmaceutical firm listed on NASDAQ under the ticker ADIL, has reached a significant milestone in its development of AD04, a treatment aimed at Alcohol Use Disorder (AUD). The company recently announced the completion of patient dosing in the pharmacokinetics study for the drug, which targets individuals who consume less than 10 drinks per drinking day.

AD04 is designed as a serotonin-3 receptor antagonist and is genetically targeted to treat heavy drinking patients with AUD. The pharmacokinetics study was conducted in two cohorts, and the last patient in the second cohort has now received their final dose. Results from both cohorts of this study are anticipated in the fourth quarter of 2024.

Cary Claiborne, Adial's President and Chief Executive Officer, emphasized the importance of this milestone, noting that the completion of dosing is a pivotal step toward initiating the Phase 3 clinical trial. This upcoming trial will focus on optimizing the dosing to maximize the efficacy and safety of AD04 in treating AUD. Claiborne highlighted that these developments underscore the company's dedication to advancing AD04 and enhancing its potential success as a viable treatment for AUD. He also mentioned that the data from this trial will be crucial in ongoing partnership discussions.

The next phase for Adial involves a thorough review of the pharmacokinetic data gathered from the study. The company plans to integrate these insights into their overall development strategy. Following the release of the topline results in the fourth quarter, Adial intends to engage in detailed discussions with the FDA to ensure their future plans align with regulatory expectations.

The study was conducted as a single-center, open-label trial to assess the relative bioavailability and dose proportionality of AD04. Thirty healthy adult volunteers were enrolled, and the study compared the pharmacokinetic profile of an oral dose of 0.33 mg of AD04, administered with or without food, against a reference standard product.

Adial Pharmaceuticals focuses on developing treatments for addictions and related disorders. Beyond AUD, AD04 is believed to have potential applications in treating other addictive conditions such as Opioid Use Disorder, gambling, and obesity. The company's lead investigational new drug, AD04, was previously evaluated in the ONWARD™ pivotal Phase 3 clinical trial. This trial targeted subjects with specific genotypes identified through a companion diagnostic genetic test. ONWARD yielded promising results, demonstrating a reduction in heavy drinking without significant safety or tolerability issues.

In summary, Adial Pharmaceuticals has reached a crucial juncture in the development of AD04 with the completion of patient dosing in the pharmacokinetics study. The forthcoming Phase 3 clinical trial aims to refine the dosing to enhance the drug’s effectiveness and safety for treating AUD. The insights gained from the current study will form a critical part of the company's broader development plan and regulatory discussions. Additionally, AD04's potential applications extend beyond AUD, offering hope for treating various other addictive disorders.