Assembly Biosciences announces interim PK, efficacy from Phase 1b study

Assembly Biosciences (ASMB) announced interim safety, pharmacokinetic, PK, and efficacy results from participants with chronic hepatitis B virus, HBV, infection in its ongoing Phase 1b study evaluating ABI-4334, an investigational next-generation capsid assembly modulator, CAM. Improvements in trial-defined measures of antiviral activity were observed in the first Phase 1b cohort that received an oral, once-daily dose of 150 mg of ABI-4334 over a 28-day treatment period. A mean decline in HBV DNA of 2.9 log10 IU/mL was observed in a population of predominately hepatitis B e antigen negative participants. In this initial 150 mg cohort, ABI-4334 continued to show a half-life supportive of once-daily oral dosing and maintained clinical exposures multiple-folds above those anticipated to be required for potent antiviral activity and inhibition of cccDNA formation. Safety data for study participants in both cohorts to date demonstrated that ABI-4334 was well-tolerated with a favorable safety profile observed.