Boehringer Ingelheim links with Presidio on interferon-free hepatitis C treatment regimens

The US subsidiary of German family-owned drug major Boehringer Ingelheim says it has completed  patient enrollment for a Phase IIa clinical trial (NCT01859962 ) investigating a new interferon-free, all-oral, direct-acting antiviral (DAA) combination treatment for patients with genotype-1a chronic hepatitis C virus (HCV) infection.

This trial is conducted in collaboration with privately-held USA-based Presidio Pharmaceuticals and evaluates Boehringer Ingelheim's investigational compounds, the protease inhibitor faldaprevir (BI 201335) and non-nucleoside NS5B polymerase inhibitor, deleobuvir (BI 207127), in combination with Presidio's investigational pan-genotypic NS5A inhibitor, PPI-668, with and without ribavirin.

The trial includes 36 treatment-naive genotype-1a infected patients treated for 12 weeks with this all-oral DAA regimen, with 24 weeks of post-treatment follow-up. The primary endpoint of the trial is sustained virologic response 12 weeks after treatment is completed (SVR12). This Phase IIa trial of a novel combination therapy is a part of Boehringer Ingelheim's commitment to develop new, tailored interferon and ribavirin-free HCV regimens for a broad range of HCV patients.