EXCLUSIVE: Adial Pharmaceuticals Moves Forward To Second Cohort In Pharmacokinetics Study of AD04 For Alcohol Use Disorder

On Tuesday, Adial Pharmaceuticals Inc ADIL announced the progression to the second cohort in the pharmacokinetics study of AD04.

AD04 is the company’s lead investigational genetically targeted serotonin-3 receptor antagonist, a therapeutic agent for Alcohol Use Disorder (AUD) in heavy drinking patients, following the completion of the first cohort.

Also Read: EXCLUSIVE: Adial Pharmaceuticals Announces Publication In Journal Supporting the Potential Efficacy Of AD04 For Alcohol Use Disorder.

Topline results from both cohorts are expected to be announced during the fourth quarter of 2024.

Cary Claiborne, President and Chief Executive Officer of Adial, commented, “We are pleased with the progress of our pharmacokinetics study of AD04. The successful completion of the first cohort allows us to advance to the second cohort as planned, staying on track with our projected timeline.”

“The results from both cohorts will offer invaluable insights that are critical for the design of our upcoming Phase 3 Clinical Trial. We anticipate engaging with the FDA following receipt of the topline data from this study and seek their feedback on the overall design of our Phase 3 program,” Claiborne added.

The pharmacokinetics study was initiated in June 2024 and is expected to be completed during the fourth quarter of 2024.

The single-center open-label relative bioavailability and dose proportionality study will enroll up to 30 healthy adult volunteers and compare the pharmacokinetic profile of AD04 when administered as an oral dose of 0.33 mg with or without food against a reference standard product.

This study will provide information on AD04’s pharmacokinetic properties.

Price Action: ADIL stock closed at $1.06 on Monday.

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