On Wednesday, Adial Pharmaceuticals, Inc. ADIL announced that the final patient completed the last dose in the pharmacokinetics study of AD04 for Alcohol Use Disorder (AUD) in heavy drinking patients (defined as <10 drinks/drinking day).
AD04 is the company's lead investigational genetically targeted serotonin-3 receptor antagonist therapeutic agent.
The single-center open-label relative bioavailability and dose proportionality study enrolled 30 healthy adult volunteers and will 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.
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, said, "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."
"Our immediate focus will now shift to a thorough review of the important pharmacokinetic data gathered from this study…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."
In July, Adial Pharmaceuticals announced the progression to the second cohort in the pharmacokinetics study of AD04. The pharmacokinetics study was initiated in June 2024.
Price Action: ADIL stock closed at $1.00 on Tuesday.
Read Next:
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Comments
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
