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Adial Pharmaceuticals Announces Positive Topline Results from the AD04-103 Pharmacokinetics Study of AD04 for the Treatment of Alcohol Use Disorder
Confirmed relative bioavailability to the reference standard, dose proportional increases in pharmacokinetic exposure, and no food effect Marks final study
About this update from Adial Pharmaceuticals, Inc
[{"type":"text","content":"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, i...