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1. Huge drug market for HBV
(1) In 2016 global HBV prevalence is 3.9%, with 292m cases, within which 32% of cases need therapies. In 2017, 870,000 people have been dead from HBV. 25% of HBV patients develop HCC.
(2) Patients receiving Long-term treatment with the current therapies easily relapse after off-treatment. And uncleared HBsAg causes an unexpected immune reaction for a long time. A low functional cure rate is a big challenge for HBV therapy, and new strategies are in need to reform HBV therapy.
2. Capsid assembly inhibitors are a viable strategy for HBV
Capsid assembly inhibitors bind to the dimer-dimer interface and disrupt the formation of functional nucleocapsids, blocking several steps of the HBV life cycle including entry, replication, assembly, and secretion and preventing maturation of infectious viral particles.
3. Asset efficiently disturbing capsid assembly and synthesis and inhibiting cccDNA formation in vitro.
(1) Asset increased the proportion of misshapen particles similar to Bay41-4109.
(2) Asset treatment led to HBcAg aggregation and accelerated intracellular HBcAg degradation and inhibited the synthesis of capsids.
(3) In the HepG2-NTCP-expressing cell line, the asset showed a stronger cccDNA formation inhibition compared to Bay41-4109.
4. Excellent active against NA-resistant HBV.
Asset demonstrates Inhibitory activity in serval NA-resistance HBVmuts. Compared with current NA drugs, the asset remains a broader applicable patient.
5. Cheerful clinical trial date: successfully decreasing in HBsAg and HBeAg levels, respectively.
(1) Phase IIa study showed 0.4log and 1.0log reduction in HBsAg and HBeAg levels, respectively, with 24 weeks of treatment.
(2) The combination of asset and ETV in the phase IIb study accelerated HBV DNA reduction. 0.4log and 0.5log average reduction in HBsAg and HBeAg levels, respectively, with 12 weeks of treatment. Deeper inhibition of HBV replication and HBsAg increases the chance of functional cure in the long run.
1. Asset type: Capsid Assembly Inhibitors for HBV
2. Indication: HBV
3. Research phase: Phase 3 China, Phase 2, US
4. Cooperation demands: License-out or co-development
5. Research progress：
(1) Phase 3 trial is ongoing.
(2) Cheerful phase II results with high expectations for functional cure in long run based on the clinical trial.
(3) Demonstrated inhibitory activity in serval NA-resistance HBVmuts.
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