A randomized, multi-center, open-label Phase 2 clinical trial will explore the safety, pharmacokinetics, and antiviral activity of the triple combination of HBV core inhibitor ABI-H0731 [from ASMB], RNAi therapeutic AB-729 [from ABUS] and an NrtI [Vemlidy or Baraclude]compared to the double combinations of ABI-H0731 with an NrtI and AB-729 with an NrtI.
This clinical trial is projected to initiate in the first half of 2021 and enroll approximately 60 virologically-suppressed patients with HBeAg negative or positive chronic HBV infection. Patients will be dosed for 48 weeks, with a 24 week follow-up period.
The companies are sharing the cost of the trial, but no other money is changing hands.
Note that ABI-H0731 is not ASMB’s latest-generation core inhibitor (CpAM), and it has shown only modest efficacy as monotherapy—see #msg-156515976 and #msg-152253534.
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