Presidio’s HCV program targets the HCV NS5A and NS5B proteins and is well positioned to compete in the HCV therapy market. Presidio’s lead pan-genotypic HCV NS5A inhibitor, ravidasvir hydrochloride (formerly known as PPI-668), has completed Phase 1 clinical studies in both healthy volunteers and HCV patients, where it exhibited potent antiviral activity, enhanced PK properties and an excellent safety/tolerance profile. A Phase 2a 12-week combination study in HCV 1a patients that included the protease inhibitor, faldaprevir (BI201335), and the non-nucleoside inhibitor, deleobuvir (BI207127), with or without ribavirin was completed in 1Q14 and demonstrated SVR24 in 92% of patients treated in RBV-containing arms and 86% in the overall trial population. Three patients in the trial attained SVR24 after only 8 weeks of therapy, of which two patients did not receive ribavirin. Presidio’s second pan-genotypic HCV inhibitor, PPI-383, is a NS5B non-nucleoside inhibitor currently being evaluated in Phase 1 studies.
Presidio has an extensive intellectual property portfolio for its HCV programs, issued US patents for ravidasvir hydrochloride (formerly known as PPI-668) and PPI-383, and strong U.S. and international patent positions in all development compounds.