Date: 2011-11-05
Type of information:
phase: 2
Announcement: Results
Company: Novartis (Switzerland)
Product: Debio 025 (alisporivir)
Action mechanism: This oligopeptide is a cyclophilin (Cyp)-binding molecule with potent anti-hepatitis C virus (HCV) activity both in vitro and in vivo. It binds to CypA, a peptidyl-prolyl cis-transisomerase which is a crucial cofactor for HCV replication.
Disease: Hepatitis C
Therapeutic area: Infectious diseases
Country:
Trial
details: The study presented at AASLD was an international multicentre, randomized, parallel-group, open-label, multi-dose, exploratory 12-week interim analysis of 334 previously untreated chronic hepatitis C patients with genotypes 2 and 3. It evaluated the efficacy and safety of DEB025 either alone or in combination with ribavirin in terms of negative HCV RNA. In addition, the study examined the effect of add-on interferon treatment. There was a low incidence of serious adverse events, with rates of adverse events comparable between treatment groups. A low number of patients experienced a transient increase in bilirubin more than five times the upper limit of normal and all without any signs of liver toxicity. Interferon-free regimens displayed lower rates of flu like symptoms in comparison to the interferon arms.
Latest
news: Novartis has announced new Phase II data showing that first-in-class DEB025 (alisporivir) may produce early viral elimination (or clearance) in interferon-free regimens (as monotherapy or with ribavirin), in previously untreated patients infected with the hepatitis C virus (HCV) genotypes 2 and 3. Almost half the patients (49%) in the study on DEB025 plus ribavirin achieved viral clearance (negative HCV RNA) 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. A pivotal Phase III study with DEB025 is ongoing to evaluate the efficacy and safety of DEB025 plus interferon and ribavirin in previously untreated HCV genotype 1 patients. Other Phase II trials are ongoing in other patient populations, i.e., genotype 1 experienced patients. Novartis licensed DEB025 from Debiopharm Group, an independent biopharmaceuticals company based in Switzerland, under an agreement that gives Novartis exclusive worldwide development, manufacturing and marketing rights (excluding Japan). These 12-week results were presented at the Association for the Study of the Liver (AASLD) Congress in San Francisco, United States. Also presented were new data on the compound\'s unique mode of action and high barrier to resistance in previously untreated patients infected with the HCV genotype 1. Novartis has announced new Phase II data showing that first-in-class DEB025 (alisporivir) may produce early viral elimination (or clearance) in interferon-free regimens (as monotherapy or with ribavirin), in previously untreated patients infected with the hepatitis C virus (HCV) genotypes 2 and 3. Almost half the patients (49%) in the study on DEB025 plus ribavirin achieved viral clearance (negative HCV RNA) 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. A pivotal Phase III study with DEB025 is ongoing to evaluate the efficacy and safety of DEB025 plus interferon and ribavirin in previously untreated HCV genotype 1 patients. Other Phase II trials are ongoing in other patient populations, i.e., genotype 1 experienced patients. Novartis licensed DEB025 from Debiopharm Group, an independent biopharmaceuticals company based in Switzerland, under an agreement that gives Novartis exclusive worldwide development, manufacturing and marketing rights (excluding Japan). These 12-week results were presented at the Association for the Study of the Liver (AASLD) Congress in San Francisco, United States. Also presented were new data on the compound\'s unique mode of action and high barrier to resistance in previously untreated patients infected with the HCV genotype 1.
