Adial Pharmaceuticals Completes Database Lock in AD04 Alcohol Use Disorder Study

Adial Pharmaceuticals, Inc., a biopharmaceutical firm focused on addiction treatment, announced the database lock for their pharmacokinetics study of AD04, their leading investigational drug for Alcohol Use Disorder (AUD). This milestone means that the collected data has now been transferred to independent statisticians for analysis, with topline results expected by the fourth quarter of 2024.

Cary Claiborne, Adial's President and CEO, emphasized the significance of this development. He noted that the upcoming data analysis would be crucial for the company's next interaction with the FDA. Claiborne expressed optimism that the results would bolster the company's strategic positioning for future clinical development and potential collaborations.

The pharmacokinetics study in question was a single-center, open-label trial involving 30 healthy adult volunteers. The study aimed to compare the pharmacokinetic profile of AD04, administered at a 0.33 mg oral dose, both with and without food, against a reference standard product.

Adial Pharmaceuticals is dedicated to developing treatments for addiction and related disorders. Their flagship product, AD04, is a serotonin-3 receptor antagonist designed to treat AUD in heavy drinking patients. The drug has already shown promise in the ONWARD pivotal Phase 3 clinical trial, which targeted specific genotypes identified through a companion diagnostic genetic test. The trial demonstrated that AD04 could reduce drinking in heavy drinkers without significant safety or tolerability issues.

Additionally, AD04 shows potential for treating other addictive disorders, including Opioid Use Disorder, gambling addiction, and obesity. The insights from the pharmacokinetics study of AD04 are expected to inform the company's clinical strategy for their upcoming Phase 3 study and strengthen their position for future strategic partnerships.

In summary, Adial Pharmaceuticals' recent progress with their pharmacokinetics study of AD04 marks a significant step forward in their efforts to develop effective treatments for addiction. With the data now in the hands of statisticians, the company is preparing for the next phase of their clinical development, aiming to reinforce their strategic plans and explore potential collaborations. The forthcoming topline results, anticipated in the fourth quarter of 2024, will be a crucial factor in shaping the company's future endeavors in combating addiction and related disorders.