Assembly Biosciences announced encouraging interim safety, pharmacokinetic, and efficacy results from its Phase 1b study evaluating ABI-4334, a next-generation capsid assembly modulator for chronic hepatitis B virus (HBV) infection. ABI-4334 was well-tolerated with a favorable safety profile and a half-life supporting once-daily oral dosing.
In the first 150 mg dose cohort, ABI-4334 demonstrated strong antiviral activity, showing a mean reduction of 2.9 log IU/mL in plasma HBV DNA over 28 days of treatment. Among participants with detectable HBV RNA at baseline, a mean decline of 2.5 log U/mL for HBV RNA was observed.
Enrollment is ongoing for the second cohort evaluating a 400 mg dose, with data anticipated in the first half of 2025. These initial antiviral data are consistent with the high potency observed preclinically for ABI-4334, reinforcing its potential to achieve the target clinical profile.
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