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Adial Pharmaceuticals Announces Positive Clinical Study Results from the AD04-103 Pharmacokinetics Study of AD04 for the Treatment of Alcohol Use Disorder
Completion enables the End-of-Phase 2 (EOP2) interaction with the FDA on the design of the Phase 3 program and is expected to facilitate ongoing partnership
About this update from Adial Pharmaceuticals, Inc
[{"type":"text","content":"Completion enables the End-of-Phase 2 (EOP2) interaction with the FDA on the design of the Phase 3 program and is expected to facilitate ongoing partnership discussions Adial’s formulation exhibited predictable bioavailability relative to the reference standard; near-micro doses exhibited dose proportionality in pharmacokinetic exposure, and no food effect Safety and tolerability consistent with ondansetron’s extensive human use experience GLEN ALLEN, Va., Jan. 29, 2025 (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 the completion of a pharmacokinetics (PK) study of AD04, and has made a regulatory submission of the results to the FDA. AD04 is the Company's investigational drug candidate, a selective serotonin-3 receptor (5-HT3) antagonist being developed for the treatment of Alcohol Use Disorder (AUD) in patients with a 5-HT3 genomic biomarker. These study results support the near micro-dosing regimen planned for use in the upcoming registration trials for AD04 and conform with the FDA’s bridging requirements for a 505(b)(2) registration pathway. The purpose of the study, AD04-103, was to evaluate the PK, bioavailability, and food effect of AD04 near-micro doses relative to marketed ondansetron in healthy volunteers (HVs). The study was conducted in two phases and enrolled a total of 30 HVs in two cohorts. Cohort 1 (n=6): A randomized, open-label, two-sequence, two-period crossover study evaluating the PK variability of ondansetron in AD04 0.33 mg and 0.99 mg doses.Cohort 2 (n=24): A randomized, open-label, six-sequence, four-period crossover study evaluating the relative bioavailability of AD04 0.33 mg tablets compared to marketed ondansetron 4 mg tablets, the dose proportionality of ondansetron PK between AD04 0.33 mg and 0.99 mg doses, and the food effect on the bioavailability of ondansetron administered as AD04 0.33 mg tablets. The results of the study confirmed that ondansetron pharmacokinetic exposure increased proportionally across a three–fold AD04 dose range, between AD04 0.33 mg tablets and the marketed ondansetron 4 mg tablets. Additionally, the study demonstrated that AD04 can be taken with or without food. Cary Claib...