Confirmed relative bioavailability to the reference standard, dose proportional increases in pharmacokinetic exposure, and no food effect

Marks final study needed for the upcoming FDA meeting for the Phase 3 study design and ongoing partnership discussions

Continued excellent safety and tolerability findings, consistent with extensive human use experience with ondansetron

GLEN ALLEN, Va., Nov.  14, 2024  (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) ("Adial" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, announced that it has completed a pharmacokinetics (PK) study of AD04, the Company's lead investigational genetically targeted, serotonin-3 receptor antagonist, and therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients (defined as less than 10 drinks/drinking day). This data will help the Company optimize study design elements needed for the upcoming Phase 3 clinical trial of AD04. Completion of this study also satisfied an FDA requirement for the upcoming Phase 3 clinical trials of AD04.

The study, a single-center, relative bioavailability, open label study, enrolled a total of 30 healthy adult volunteers in two cohorts. Cohort 1 (n=6) was a randomized, open-label, 2-sequence, 2-period crossover study to evaluate the PK variability of ondansetron from AD04 0.33 and 0.99mg. Cohort 2 (n=24) was a randomized, open-label, 6-sequence, 4-period crossover study to evaluate the relative bioavailability of the AD04 0.33mg tablet to a marketed ondansetron 4mg tablet, dose proportionality of ondansetron PK between AD04 0.33 and 0.99mg, and the effect of food on the bioavailability of ondansetron administered as the AD04 0.33mg tablet. The results of this study showed that, as a result of the lower dose, AD04 0.33mg delivered lower ondansetron PK exposure than the marketed reference standard ondansetron 4mg tablet; ondansetron pharmacokinetic exposure increased in proportion to dose across a 3–fold AD04 dose range; and AD04 can be taken in fed or fasted states.

Cary Claiborne, President and Chief Executive Officer of Adial commented, "Completion of this study achieves our goal to obtain the data we needed to design a more precise and informed Phase 3 trial protocol, including evaluating the optimal dosing regimen to maximize the efficacy and safety of AD04 in patients with AUD. Its completion is in accord with previous guidance provided by the FDA and is intended to enhance the likelihood of success in our upcoming Phase 3 trial. This relatively short and low-cost study was a key element of our strategy to advance ongoing partnership discussions. Additionally, the study will provide data necessary to support an application for approval of AD04 under a 505(b)(2) regulatory pathway with the FDA. We plan to engage with the FDA during Q4 2024 with the results of this pharmacokinetics study and obtain feedback which will assist with the AD04 Phase 3 study program. This meeting is an important next step to further advancing AD04 towards regulatory approval."