Pipeline

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:

  1. NAP dosing regimens which are well tolerated and effective in removing serum HBsAg.
  2. Efficacy of NAP regimens in different ethnic patient populations.
  3. Tolerability of immunotherapy and NUC therapy in the presence of NAP backbone therapy.
  4. Optimization of NAP-based combination therapy to achieve the highest SVR rates possible (functional cure).
  5. Selection of final NAP candidate for continued development to NDA.

Replicor’s current proof of concept pipeline is as follows:
pipeline1

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.