Hence, even if the individual clears hepatitis B surface antigen (HBsAg), the hepatocyte still harbours cccDNA
Data presented from a 12-week study in the chronic woodchuck model of HBV infection demonstrate significant reductions in viral loads, surface antigen and cccDNA
along with a strong safety profile, suggesting the potential of SB 9200 as a next generation HBV therapy in combination with currently available, direct acting HBV antiviral drugs as well as other agents in development.
There is an urgent need for the development of new classes of antiviral agents such as SB 9200, that have the potential to reduce viral antigens, eliminate cccDNA
, and effect viral clearance.
In a pivotal 12-week study in woodchucks chronically infected with hepatitis virus, SB 9200 demonstrated potent, dose-dependent inhibition of viral replication, potent suppression of surface antigen, significant reduction in cccDNA
and overall slowdown of liver disease progression that support the novel mechanism of action of the compound.
The registration studies will also assess improvement in liver histology, hepatitis B e-antigen (eAg) seroconversion, decreases in the reservoir of HBV hepatic cccDNA
, and quantitative eAg and surface antigen (sAg).