Assembly Biosciences (NASDAQ:ASMB) announces clinical data on lead HBV core inhibitor vebicorvir (ABI-H0731) and second-generation core inhibitor ABI-H2158. The results were virtually presented at the European Association for the Study of the Liver (EASL) Annual Meeting.
Vebicorvir, combined with nucleos(t)ide reverse transcriptase inhibitor (NrtI) therapy in patients with HBeAg-negative chronic hepatitis B virus (HBV) infection showed a significant benefit. Specifically, 30% of patients in the mid-stage 211 study who were virologically suppressed at baseline had evidence of residual viral replication as determined by the company’s highly sensitive HBV DNA test despite long-term NrtI therapy (median duration four years). The addition of vebicorvir resulted in almost all patients reaching undetectable levels of HBV DNA. About 88% of study participants will achieve the stopping criteria and will be taken off therapy to be assessed for sustained virologic response (SVR). Vebicorvir continues to show a favorable safety profile.
It second-generation core inhibitor, ABI-H2158, showed 10x greater potency against covalently closed circular DNA (cccDNA), a certain DNA structure that arises from the propagation of HBV, than vebicorvir in preclinical testing. It also showed a favorable safety profile in a Phase 1b dose-ranging study.
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