Novartis has presented promising new mid-stage data on its first-in-class hepatitis C drug alisporivir.
The Swiss major has announced new Phase II data showing that DEB025 (alisporivir) may produce early viral elimination (or clearance) in interferon-free regimens in previously untreated patients infected with the hepatitis C virus (HCV) genotypes 2 and 3.
The 12-week results, presented at the Association for the Study of the Liver (AASLD) Congress in San Francisco, showed that almost half the patients (49%) in the study on DEB025 plus ribavirin achieved viral clearance as early as week six. One-third of patients (32%) receiving DEB025 alone also achieved viral clearance after six weeks.
In addition, 97% of patients with viral clearance who continued to receive interferon-free DEB025 plus ribavirin maintained this viral clearance up to week 12, Novartis noted. The firm added that after genotype 1, genotypes 2 and 3 are the second most prevalent forms of HCV worldwide.
The company quoted Jean-Michel Pawlotsky of the Hopital Henri Mondor, Creteil, France, and the study’s principal investigator, as saying that HCV is difficult to treat and newly-licensed direct-acting antivirals - Merck & Co's Victrelis (boceprevir) and Vertex's rival Incivek (telaprevir) - are not indicated for genotypes 2 and 3 patients. This leaves the latter "without new treatment options and with no improvement in tolerability over interferon plus ribavirin, the standard of care”.
He added that “these positive results suggest that DEB025 may be a valuable future treatment option either alone or in combination regimens, providing physicians with flexibility in the treatment process along with favourable tolerability and a high barrier to resistance". A Phase III study with alisporivir, is a cyclophilin inhibitor, is ongoing to evaluate the drug plus interferon and ribavirin in previously-untreated HCV genotype 1 patients.
Novartis licensed DEB025 from Debiopharm Group of Switzerland in February 2009.