Novira’s lead core inhibitor candidate, NVR 3-778, disrupts the HBV lifecycle by inducing the assembly of defective capsids and is a potent inhibitor of HBV replication both in cell culture models and a humanized liver mouse model of CHB. An excellent preclinical safety profile has been established for NVR 3-778 and a Phase 1 clinical trial is underway in New Zealand.
This novel mechanism of action promises to change the paradigm for CHB treatment. When used in combination with the current standard of care (nucleosides and interferon), Novira’s core inhibitors are expected to provide greater and faster suppression of cccDNA and new virus production. Directly or indirectly, core inhibitors may also reduce HBsAg levels and release the block on immune response pathways to further reduce the time to cure. Higher and faster cure rates promoted by core inhibitors will in turn enable finite therapy so that many CHB patients will no longer require lifelong treatment.