Assembly Biosciences announced positive topline efficacy, safety, and pharmacokinetic results from its Phase 1b study evaluating ABI-4334, a next-generation capsid assembly modulator, in participants with chronic hepatitis B virus (HBV) infection. The final 400 mg cohort demonstrated potent antiviral activity over 28 days, similar to the previously reported 150 mg dose cohort.
Mean HBV DNA reductions of 3.2 log IU/mL were observed in the 400 mg cohort, consistent with the 2.9 log IU/mL reduction in the 150 mg cohort. ABI-4334 continued to show a favorable safety and tolerability profile, along with pharmacokinetics supporting once-daily oral dosing across both cohorts.
The completion of this trial triggers an opt-in point under the collaboration agreement with Gilead Sciences, Inc. Gilead now has the right to opt in to an exclusive license for further development and commercialization of ABI-4334 after reviewing the data package, representing a significant potential milestone for Assembly Bio.
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