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Assembly Biosciences Reports Positive Topline Results from Phase 1b Clinical Trial of Next-Generation Investigational Capsid Assembly Modulator ABI-4334 in Chronic Hepatitis B
– Favorable safety and tolerability profile, as well as pharmacokinetics supporting once-daily oral dosing, continued to be observed in final 400 mg cohort – – Mean plasma HBV DNA reductions of 3.2 logs IU/mL over 28 days of treatment for 400 mg cohort consistent with findings in 150 mg cohort, supporting ability of 150 mg dose to achieve saturated inhibition of viral replication, as anticipated – – Trial completion triggers opt-in point under collaboration with Gilead Sciences, Inc. following d
About this update from Assembly Biosciences, Inc.
[{"type":"image","alt":"Assembly Biosciences, Inc.","displaySize":"","headline":null,"caption":"Assembly Biosciences, Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":62,"url":"https://media.zenfs.com/en/globenewswire.com/4e437adc40e964d1c4e7b4b8eba4cdc8"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/MDnne0t7yPjd24iiqZ4Sig--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTg3O2NmPXdlYnA-/https://media.zenfs.com/en/globenewswire.com/4e437adc40e964d1c4e7b4b8eba4cdc8","width":300,"height":62}},"lazy":false},{"type":"text","content":"– Favorable safety and tolerability profile, as well as pharmacokinetics supporting once-daily oral dosing, continued to be observed in final 400 mg cohort –","length":157,"tagName":"p"},{"type":"text","content":" – Mean plasma HBV DNA reductions of 3.2 logs IU/mL over 28 days of treatment for 400 mg cohort consistent with findings in 150 mg cohort, supporting ability of 150 mg dose to achieve saturated inhibition of viral replication, as anticipated – ","length":242,"tagName":"p"},{"type":"text","content":"– Trial completion triggers opt-in point under collaboration with Gilead Sciences, Inc. following delivery and review of option data package –","length":142,"tagName":"p"},{"type":"text","content":"SOUTH SAN FRANCISCO, Calif., June 25, 2025 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral diseases, today announced positive topline efficacy, safety and pharmacokinetic (PK) results from a Phase 1b study evaluating ABI-4334, an investigational next-generation capsid assembly modulator (CAM), in participants with chronic hepatitis B virus (HBV) infection.","length":456,"tagName":"p"},{"type":"text","content":"In the cohort evaluating a 400 mg oral daily dose, potent antiviral activity was observed over the 28-day treatment period similar to that previously reported for the 150 mg dose cohort. The relationship between ABI-4334's observed antiviral activity and its exposure profile was consistent with having reached full engagement of the first mechanism of action for CAMs, inhibition of viral replication, at the lower 150 mg dose. Safety and PK data from the 400 mg cohort continue to support a once-daily oral dosing profile, while reaching exposure levels at greater multiples of the target exposure a...