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news.The Phase II study of Novartis' first-in-class antiviral DEB025 (alisporivir) met its primary endpoint of achieving viral cure (24 weeks after stopping treatment) in 76% of patients with chronic hepatitis C 1.
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The study, a 48-week, global, double-blind, randomized, placebo-controlled trial, involved nearly 300 previously untreated patients infected with the most common form of hepatitis C virus (HCV), the genotype 1 (G1)1.
It evaluated the efficacy and safety of DEB025 combined with pegylated-interferon alfa 2a/ribavirin (PegIFN/RBV) vs. PegIFN/RBV alone.
A pivotal Phase III study with DEB025 commenced recently to evaluate the efficacy and safety of DEB025 combined with standard of care and enrolling previously untreated HCV G1 patients.
Other Phase II studies are ongoing in other patient populations i.e., G1 treatment-experienced patients and G2 and G3 treatment-naive patients.
Novartis in-licensed exclusive worldwide development, manufacturing and marketing rights (excluding Japan) of DEB025 from Switzerland-based independent biopharmaceuticals company Debiopharm Group.
DEB025 is the first in a new class of drugs called cyclophilin inhibitors.
Unlike other compounds in development that target the virus directly, DEB025 is a host targeting antiviral (HTA) that targets so-called host proteins which are essential for the replication of HCV.
Novartis Pharma Development global head Trevor Mundel said DEB025 has a new mode of action that may stop the virus from replicating and could reshape the future approach to treatment of hepatitis C.