Presidio Pharmaceuticals has entered a non-exclusive collaboration with Boehringer Ingelheim for a Phase IIa trial of an interferon-free, oral, direct-acting antiviral (DAA) combination treatment for patients with chronic hepatitis C virus (HCV) infection. The trial will evaluate Presidio’s pan-genotypic HCV NS5A inhibitor (PPI-668) in combination with Boehringer’s HCV protease inhibitor faldaprevir (BI201335) and its non-nucleoside HCV polymerase inhibitor (BI207127), with or without ribavirin.
The companies will initiate the Phase II treatment study in 2Q13. The trial will measure on-treatment antiviral responses and sustained virologic response rates (SVR) to the triple DAA combination regimen, with or without ribavirin. Presidio will have primary responsibility for the trial, in collaboration with BI. Both companies will retain all rights to their respective compounds.
Dr. Nathaniel Brown, Presidio’s chief medical officer, remarked, “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. The study will assess the potential of this three-drug oral regimen to achieve high rates of sustained viral clearance in hepatitis C patients, with good tolerance.”