Assembly Biosciences reports positive topline results from Phase 1b clinical trial of next-generation investigational capsid assembly modulator ABI-4334 in chronic hepatitis B
Assembly Biosciences, Inc. 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.
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 anticipated to fully engage a second mechanism of action of CAMs, inhibition of formation of the viral reservoir, cccDNA.
Read the full company press release here.
Source : Assembly Biosciences
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