Assembly Biosciences Doses First Participant in Phase 1b Clinical Trial Evaluating Next-Generation Capsid Assembly Modulator Candidate ABI-4334 for the Treatment of Chronic Hepatitis B Virus Infection

Core Insights - Assembly Biosciences, Inc. has initiated dosing for the Phase 1b trial of ABI-4334, a next-generation capsid assembly modulator aimed at treating chronic hepatitis B virus (HBV) infection [1][4] - Chronic HBV infection is a significant global health issue, leading to over one million deaths in 2022, with current treatments offering low cure rates [2] - ABI-4334 is designed to inhibit HBV DNA replication and prevent the formation of new cccDNA, showing promising preclinical potency [2][3] Company Overview - Assembly Biosciences is focused on developing innovative small molecule therapeutics for serious viral diseases, including HBV and hepatitis delta virus (HDV) [7] - The company is led by a team experienced in virologic drug development, aiming to improve patient outcomes [7] Clinical Trial Details - The Phase 1b study, ABI-4334-102, is a randomized, blinded, placebo-controlled trial enrolling up to 50 subjects to evaluate safety, pharmacokinetics (PK), and antiviral activity over a 28-day treatment period [5] - The trial will assess the impact of escalating doses of ABI-4334 on HBV DNA levels and gather key safety data [4][5] - Interim results from the study are expected to be reported later in the year [4]