Assembly Biosciences(US:ASMB) Globenewswireยท2025-06-25 12:00Core Insights - Assembly Biosciences, Inc. announced positive topline results from a Phase 1b study of ABI-4334, demonstrating favorable safety, tolerability, and pharmacokinetics for once-daily oral dosing in chronic hepatitis B virus (HBV) infection [1][3][4] Efficacy and Safety - In the 400 mg cohort, mean plasma HBV DNA reductions of 3.2 logs IU/mL were observed over 28 days, consistent with the 150 mg cohort, indicating effective viral replication inhibition [1][2][10] - ABI-4334 showed a favorable safety profile with no serious adverse events reported, and only two grade three treatment-emergent lab abnormalities were noted, both of which resolved [8][9] Pharmacokinetics - The pharmacokinetic data indicated that ABI-4334 maintained exposure levels significantly above those required for potent antiviral activity and inhibition of cccDNA formation, supporting its once-daily dosing regimen [4][10] - Slightly higher than dose-proportional increases in clinical pharmacokinetic exposures were observed from the 150 mg to the 400 mg dose [10] Collaboration and Future Steps - The completion of the trial triggers an opt-in point for Gilead Sciences, Inc. to review the option data package for potential exclusive licensing of ABI-4334 for further development and commercialization [1][5] - Discussions regarding the next steps for ABI-4334 will be supported by the trial results as Gilead evaluates its options [3][5]