Novartis presents 12-week results from its new phase II data of alisporivir at the Association for the Study of the Liver (AASLD) Congress in San Francisco, US. The data shows 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. The company also presented 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.
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. Achieving an early viral clearance is considered one of the most important predictors of sustained viral response, also known as viral cure. After genotype 1, genotypes 2 and 3 are the second most prevalent forms of HCV worldwide.
"Hepatitis C is difficult to treat and newly licensed direct-acting antivirals are not indicated for genotypes 2 and 3 patients, and may leave these patients without new treatment options and with no improvement in tolerability over interferon plus ribavirin, the standard of care", said Professor Jean-Michel Pawlotsky, Department Head of Virology at the Hôpital Henri Mondor, Créteil, France, and the study's principal investigator. "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."
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 that targets host proteins essential for the replication of all types of HCV. As a result, DEB025 may offer an effective treatment option across HCV genotypes, with a high barrier to resistance.
"Hepatitis C remains a major public health problem with significant challenges of treatment resistance and poor tolerability," said John Hohneker, Global Head of Development for Integrated Hospital Care at Novartis. "Novartis is committed to providing healthcare professionals with innovative and effective treatments that can help them tackle this global epidemic."
More than 170 million people worldwide are infected with HCV, representing nearly 3% of the world's population. The hepatitis C virus causes serious liver disease, leading to cirrhosis, liver cancer and, in some cases, death.
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).