Date: 2013-03-13
Type of information: Clinical research agreement
Compound: oral combination of HCV NS5A inhibitor (PPI-668) with faldaprevir (BI201335) and BI207127
Company: Boehringer Ingelheim (Germany) Presidio Pharmaceuticals (USA)
Therapeutic area: Infectious diseases
Type agreement: clinical research
Action mechanism: PPI-668 is a potent, pan-genotypic, once daily, NS5A inhibitor. In earlier clinical studies in healthy volunteers and HCV-infected patients, PPI-668 has been well-tolerated to date with no serious or severe adverse events and no apparent pattern of treatment-related clinical side effects or laboratory abnormalities. In a clinical study of PPI-668 monotherapy in GT1 HCV-infected patients, viral load reductions of 3.5 to 3.7 log10 HCV were achieved in 1-2 days. Faldaprevir (BI201335) is an oral once-daily protease inhibitor, specifically designed to target and inhibit viral replication in the liver. BI207127 is an investigational, potent twice-daily non-nucleoside inhibitor of the HCV polymerase (NS5B) that inhibits HCV genotype-1 replication.
Disease: hepatitis C
Details: Presidio Pharmaceuticals has announced a non-exclusive collaboration with Boehringer Ingelheim for a Phase IIa clinical trial of an interferon-free, all-oral, direct-acting antiviral (DAA) combination treatment for patients with chronic hepatitis C virus (HCV) infection. The collaborative trial will evaluate Presidio\'s pan-genotypic HCV NS5A inhibitor (PPI-668) in combination with Boehringer Ingelheim\'s HCV protease inhibitor faldaprevir (BI201335) and its non-nucleoside HCV polymerase inhibitor (BI207127), with or without ribavirin.
Both companies have agreed to initiate the Phase II, 12-week treatment study in the second quarter of 2013. 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 Pharmaceuticals will have primary operational responsibility for the trial, in close collaboration with Boehringer Ingelheim. With the complementary antiviral activities of PPI-668, faldaprevir, and BI207127, the present study focuses on patients with HCV genotype-1a infection. The study will assess the potential of this three-drug oral regimen to achieve high rates of sustained viral clearance in hepatitis C patients. Sustained virologic response results at 4- and 12-weeks post-treatment are expected to be available in the fourth quarter of 2013. Both companies continue to retain all rights to their respective compounds during this collaboration.
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