Phase II proof of concept clinical study pipeline
The development of an effective treatment for HBV and HBV / HDV infection will involve a combination treatment. Small scale adaptive proof of concept clinical trials allow Replicor to rapidly assess the following:
- NAP dosing regimens which are well tolerated and effective in removing serum HBsAg.
- Efficacy of NAP regimens in different ethnic patient populations.
- Tolerability of immunotherapy and NUC therapy in the presence of NAP backbone therapy.
- Optimization of NAP-based combination therapy to achieve the highest SVR rates possible (functional cure).
- Selection of final NAP candidate for continued development to NDA.
Replicor’s current proof of concept pipeline is as follows:
The milestones achieved by Replicor using this proof of concept process have taken a fraction of the time to accomplish compared with the traditional development approaches and provide substantial de-risking of the regulatory approval process.