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Assembly Biosciences Provides Update on its Core Inhibitor Pipeline, Reports Fourth Quarter and Year End 2022 Financial Results and Recent Highlights
Prioritization of core inhibitor candidate ABI-4334 and pausing of core inhibitor candidate ABI-H3733 based on data to date from ongoing clinical Phase 1
About this update from Assembly Biosciences, Inc.
[{"type":"text","content":"Prioritization of core inhibitor candidate ABI-4334 and pausing of core inhibitor candidate ABI-H3733 based on data to date from ongoing clinical Phase 1 studies of both candidates and chronic toxicology observation for ABI-H3733Phase 1a complete clinical data for all ABI-4334 dose cohorts expected in April 2023Advancing expanded research portfolio, with additional development candidate nomination anticipated in 2023 and IND/CTA submission for herpesvirus candidate ABI-5366 planned for the first half of 2024 SOUTH SAN FRANCISCO, Calif., March 22, 2023 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a clinical-stage biotechnology company developing innovative antiviral therapeutics targeting serious viral diseases, today provided an update on its investigational next-generation hepatitis B virus (HBV) core inhibitors, ABI-H3733 (3733) and ABI-4334 (4334), and reported financial results and recent highlights for the fourth quarter and year ended December 31, 2022. “Last year, we accelerated our research pipeline and advanced our clinical pipeline of next-generation, highly potent HBV core inhibitors, 3733 and 4334,” said Jason Okazaki, chief executive officer and president of Assembly Bio. “While the clinical antiviral activity seen in HBV patients receiving 3733 in our Phase 1b trial is impressive, our objective has always been to prioritize the strongest candidate in a data-driven manner. Based on the data from our ongoing clinical and nonclinical studies, we are focusing on 4334 given its greater potency and encouraging clinical profile emerging from the initial cohorts in the Phase 1a study. We plan to evaluate and share data for the remaining multiple-dose cohort from that study in April.” In the 100 mg cohort of 3733 in a 28-day Phase 1b study, all seven HBeAg negative chronic HBV (cHBV) patients that have completed dosing reached the lower limit of quantification for HBV DNA by day 21. In the Phase 1a study of 4334, all single-dose cohorts and the first multiple-dose cohort of 100 mg are complete. In these cohorts, 4334’s pharmacokinetic (PK) profile continues to be supportive of once-daily oral dosing and of providing exposures sufficient to potently inhibit both HBV DNA and covalently closed circular DNA (cccDNA) formation. No serious adverse events (AEs) or patterns of clinically significant AEs or laborat...