The Food and Drug Administration (FDA) has granted Fast Track designation to ABI-H0731 (Assembly Biosciences), a novel antiviral in development for the treatment of hepatitis B virus (HBV) infection.

ABI-H0731 is an oral core protein allosteric modifier (CpAM) with selective and potent activity against all major HBV genotypes. It is currently being evaluated in 2 multicenter, randomized, placebo-controlled Phase 2a trials.

In the “viral antigen trial”, HBeAg positive HBV patients whose viral load has already been suppressed on a standard of care nucleos(t)ide therapy will be randomized to receive either daily ABI-H0731 or placebo in addition to continuing nucleos(t)ide therapy for 6 months. Declines in HBV S antigen and HBV E antigen, as well as safety and tolerability, will be assessed in this trial.

In the “viral load trial”, HBeAg positive HBV patients who are naïve to nucleos(t)ide treatment will be randomized to either daily ABI-H0731 or placebo in combination with entecavir for 6 months. Antiviral potency, safety and tolerability will be key endpoints of this study.

Initial results from both trials are expected in the first half of 2019.

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