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news.Presidio Pharmaceuticals and Boehringer Ingelheim have collaborated to commence a Phase IIa trial of an interferon-free, direct-acting antiviral (DAA) combination treatment for patients with chronic hepatitis C virus (HCV) infection.
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The all-oral combination comprises Presidio’s HCV NS5A inhibitor (PPI-668), Boehringer’s HCV protease inhibitor Faldaprevir (BI201335) and its non-nucleoside HCV polymerase inhibitor (BI207127), with or without ribavirin.
The trial will measure on-treatment antiviral responses and sustained virologic response rates (SVR) to the triple DAA combination regimen, with or without ribavirin.
The Phase II, 12-week treatment study is anticipated to be commenced in the second quarter of 2013 and sustained virologic response results at four- and 12-weeks post-treatment are expected in the second quarter of 2013.
Presidio chief medical officer Dr Nathaniel Brown said, "With the potent, complementary antiviral activities of PPI-668, faldaprevir, and BI207127, the present study focuses on patients with HCV genotype-1a infection, which has been harder to treat than HCV genotype-1b in many studies."
Presidio will take up the operational responsibility for the trial, in collaboration with Boehringer.