EXCLUSIVE: Adial Pharmaceuticals Starts Patient Dosing In Pharmacokinetics Study Of AD04 For Alcohol Use Disorder

Wednesday, Adial Pharmaceuticals Inc. ADIL announced that the first patient had been dosed in a pharmacokinetics study of AD04 for Alcohol Use Disorder in heavy drinking patients.

The study is expected to take six months to complete and is intended to produce data that will help the company optimize the study design elements needed for the upcoming Phase 3 clinical trial of AD04.

Completion of this study will also satisfy a requirement of the FDA guidance for the upcoming Phase 3 clinical trial of AD04.

Related: EXCLUSIVE: Alcohol Disorder-Focused Adial Pharmaceuticals Secures US Patent.

“This relatively short and low-cost study is also a key element of our strategy to advance ongoing partnership discussions. The study will also provide data necessary to support an application for approval of AD04 under a 505(b)(2) regulatory pathway with FDA.”

The pharmacokinetics study will involve two cohorts conducted consecutively and is expected to be completed in early Q4 2024.

The single-center, relative bioavailability, open-label study will enroll up to 30 healthy adult volunteers and compare the pharmacokinetic profile of oral AD04 of 0.33 mg taken twice daily with or without food against a reference standard product.

This study will provide information on the pharmacokinetic properties of AD04. The company expects to report topline results in early Q4 2024.

AD04 (0.33mg ondansetron taken orally twice daily) acts upon the 5HT3 pathway and is thought to reduce alcohol cravings.

Post-hoc analyses of Adial’s prior clinical studies have indicated that patients with mutations in the 5HT3 receptor experience substantial and clinically meaningful reductions in alcohol consumption.

Furthermore, in both previous clinical trials, AD04 had similar adverse events to placebo, demonstrating that it is safe and tolerable.

Adial has already developed a companion diagnostic test to identify the specific genotypes that benefit from AD04.

Price Action: ADIL shares closed at $1.36 on Tuesday.