Core Insights - Assembly Biosciences, Inc. announced positive Phase 1b clinical data for its investigational capsid assembly modulator ABI-4334, showcasing a favorable safety profile and significant reductions in viral nucleic acids [1][2][3] Group 1: Clinical Data - The Phase 1b study involved two cohorts of predominantly HBeAg-negative subjects, evaluating 150 mg and 400 mg oral doses of ABI-4334 administered once daily for 28 days [3] - ABI-4334 demonstrated well-tolerated results at both dose levels, with multi-log declines in hepatitis B virus (HBV) DNA and pregenomic RNA (pgRNA) observed, indicating effective suppression of viral replication [3] - The study results support the potential of ABI-4334 to maximize antiviral activity as part of multi-drug combination regimens targeting chronic hepatitis B infection [2][3] Group 2: Presentation and Collaboration - The complete Phase 1b data was presented in a late-breaking poster at the American Association for the Study of Liver Diseases (AASLD) conference, marking the first scientific presentation of these findings [1][2] - Under a collaboration agreement with Gilead Sciences, Gilead has the option to obtain an exclusive license for further development and commercialization of ABI-4334 after reviewing the data package post-Phase 1b study [4]
Assembly Biosciences Presents Positive Phase 1b Data for Next-Generation Capsid Assembly Modulator ABI-4334 at AASLD The Liver Meeting®