Novartis reports alisporivir Phase III success
Swiss Novartis AG’s (Basel) hepatitis C (HCV) first-in-class antiviral alisporivir (DEB025) has met the primary endpoint in a Phase IIb study. 76% of chronic hepatitis C patients with the most common G1 genotype treated with DEB025 plus standard of care (pegylated-interferon alfa 2a/ribavirin) achieved superior viral cure compared to the 55% who received standard of care alone. The drug, which targets host proteins essential for virus replication, showed a low incidence of adverse events. Last February, Novartis acquired world-wide marketing rights (excluding Japan) for the oligopeptide cyclophilin inhibitor from Debiopharm SA (Lausanne, Switzerland). The drug giant has already started a pivotal Phase III study to demonstrate safety and efficacy in patients with the G1 genotype. The substance is also being tested in Phase II trials for the G2 and G3 genotypes. DEB025’s success has become more important for Novartis since the company last April withdrew the European MAA for Joulferon (albinterferon alfa-2b), which is co-developed with Human Genome Sciences Inc. in Europe and the US.