Assembly Biosciences(US:ASMB) Newsfilterยท2024-12-26 13:00Core Insights - The article discusses the interim results of a Phase 1b clinical study evaluating ABI-4334, an investigational antiviral treatment for chronic hepatitis B virus (HBV) infection, highlighting its antiviral activity and safety profile [4][8][14]. Study Overview - ABI-4334 is being tested in a randomized, blinded, placebo-controlled, dose-ranging Phase 1b clinical study, which includes treatment-naive or off-treatment participants with either HBeAg positive or negative chronic HBV infection [6]. - The study consists of two cohorts, with the first cohort receiving a 150 mg dose and the second cohort currently enrolling participants for a 400 mg dose [19]. Interim Results - In the first cohort, participants receiving 150 mg of ABI-4334 showed a mean decline in HBV DNA of 2.9 log10 IU/mL and a mean decline in HBV RNA of 2.5 log10 U/mL among those with detectable HBV RNA at baseline over a 28-day treatment period [7][14]. - The safety data indicated that ABI-4334 was well-tolerated, with no serious adverse events reported and only two grade three lab abnormalities observed, both of which resolved with continued dosing [3][4]. Pharmacokinetics and Dosing - ABI-4334 demonstrated a half-life supportive of once-daily oral dosing, with clinical exposures significantly above the levels anticipated to be required for potent antiviral activity [14][17]. - The daily minimum plasma trough concentrations at the 150 mg dose achieved double-digit multiples over the protein-adjusted EC50 for both antiviral activity and cccDNA formation [17]. Future Expectations - Enrollment for the second cohort evaluating the 400 mg dose is ongoing, with data anticipated in the first half of 2025 [19]. - The collaboration with Gilead Sciences allows Gilead the option to further develop and commercialize ABI-4334 following the completion of this Phase 1b study [19].