Adial Pharmaceuticals Begins Second Cohort in AD04 Alcohol Use Disorder Study

Adial Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company listed on NASDAQ under the ticker ADIL, has announced the initiation of patient dosing in the second cohort of their pharmacokinetics study for their lead investigational drug, AD04. AD04 is a genetically targeted serotonin-3 receptor antagonist designed for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients, defined as those consuming fewer than 10 drinks per drinking day. This advancement follows the successful completion of the first cohort in the study.

The pharmacokinetics study, which began in June 2024, aims to enroll up to 30 healthy adult volunteers. It is a single-center, open-label study that evaluates the relative bioavailability and dose proportionality of AD04 when administered as an oral dose of 0.33 mg, both with and without food, compared to a reference standard product. This study will provide critical information on the pharmacokinetic properties of AD04, with an expected completion date in the fourth quarter of 2024. Topline results from both cohorts are anticipated to be announced around the same time.

Cary Claiborne, President and CEO of Adial Pharmaceuticals, expressed satisfaction with the progress of the study. He emphasized that the completion of the first cohort and the initiation of the second cohort are significant steps in adhering to the projected timeline. The data obtained from these cohorts will be instrumental in shaping the design of the upcoming Phase 3 Clinical Trial. Claiborne also mentioned plans to engage with the FDA upon receiving the topline data to seek feedback on the Phase 3 program's overall design.

Adial Pharmaceuticals specializes in the development of therapies for addiction and related disorders. AD04, their leading investigational product, has shown promise in treating AUD, particularly in patients with specific genetic markers identified through the company's companion diagnostic genetic test. The drug was previously evaluated in the ONWARD™ pivotal Phase 3 clinical trial, which yielded encouraging results in reducing alcohol consumption among heavy drinkers without significant safety or tolerability issues.

Beyond AUD, AD04 has potential applications in treating other addictive disorders, including Opioid Use Disorder, gambling, and obesity, making it a versatile candidate in the field of addiction treatment.

Adial Pharmaceuticals continues to make strides in its mission to develop effective treatments for addiction, leveraging genetic targeting to enhance the efficacy of their therapies. The ongoing pharmacokinetics study of AD04 is a crucial step in this journey, providing essential data that will inform the future clinical development and regulatory strategy for this promising drug.