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Boehringer Ingelheim Expands Investigation of Interferon-free Hepatitis C Treatment Regimens to Reach More Patient Types through Presidio Pharmaceuticals Clinical Collaboration
Date:9/10/2013

RIDGEFIELD, Conn., Sept. 10, 2013 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. today announced the completion of patient enrollment for a Phase 2a 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 Presidio Pharmaceuticals, Inc. 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 2a 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.

In March 2013, the two companies entered a non-exclusive collaboration to evaluate the three DAAs in combination regimens. Both companies will retain all rights to their respective compounds. Presidio has operational responsibility for this collaborative trial, with oversight by an intercompany project team. Final results are expected in Q2 2014.

"We are proud to announce that we have completed enrollment in this collaborative trial designed to investigate an all-oral combination of compounds to treat patients with HCV. This further compliments our ongoing Phase 3 HCVerso® trial
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