Presidio Pharmaceuticals Successfully Completes Phase 1 Proof-of Concept for PPI-668, its Potent HCV NS5A Inhibitor, in Hepatitis C Patients with Genotype-1 Infection
San Francisco, CA – June 26, 2012 – Presidio Pharmaceuticals, Inc. announced today successful completion of Phase 1b clinical testing of its lead HCV NS5A inhibitor in patients with HCV genotype-1 infection, with positive efficacy and safety observations supporting advancement of PPI-668 to Phase 2 combination studies.
The randomized, blinded Phase 1b trial of PPI-668 involved sequential cohorts of treatment-naïve HCV genotype-1 patients who received oral doses of PPI-668 of 40, 80, 160 or 240 mg, once daily for three consecutive days. Within each 10-patient cohort, patients were randomized 8:2 to PPI-668 or placebo.
In all of the Phase 1b dose cohorts, PPI-668 was well tolerated with no serious or severe adverse events, no premature treatment discontinuations and no apparent pattern of treatment-related clinical side effects or laboratory abnormalities. PDF
Presidio Pharmaceuticals Announces Phase 1a-1b Clinical Results with PPI-668, a Potent Pan-genotypic HCV NS5A Inhibitor
San Francisco, CA – April 19, 2012 – Presidio Pharmaceuticals, Inc. announced results today from a Phase 1a-1b clinical trial of PPI-668, a potent, pan-genotypic HCV NS5A inhibitor being developed for the treatment of patients with chronic hepatitis C.
PPI-668 is Presidio’s second NS5A inhibitor to progress to clinical testing after Phase 1 clinical evaluation of PPI-461 (results previously reported at the annual meetings of the American Association for the Study of Liver Diseases (AASLD) in 2010 and 2011). Compared to PPI-461, PPI-668 exhibits more potent activity in vitro against HCV genotypes 3a and 6a and has a superior resistance profile. PDF