Pharmasset Enters into a Clinical Collaboration Agreement with Tibotec Pharmaceuticals for a Combination Study in Patients Chronically Infected with Hepatitis C
- Study to evaluate the combination of PSI-7977 and TMC435 with and without ribavirin in prior null responder, genotype 1 HCV patients
PRINCETON, N.J., July 6, 2011 /PRNewswire/ -- Pharmasset, Inc. (NASDAQ: VRUS), announced today that it has entered into a clinical collaboration agreement with Tibotec Pharmaceuticals to evaluate in a Phase 2 study the safety and efficacy of PSI-7977, Pharmasset's investigational nucleotide polymerase inhibitor, in combination with TMC435, Tibotec Pharmaceuticals' investigational protease inhibitor, for the treatment of chronic hepatitis C virus (HCV).
This phase 2 proof of concept study will evaluate the potential to achieve sustained virologic response 12 weeks post treatment with an all oral, once-daily, interferon-free treatment regimen in patients infected with genotype 1 HCV. Specifically, the study will assess the safety, pharmacokinetics and pharmacodynamics of 12 and 24 weeks of PSI-7977 in combination with TMC435, with and without ribavirin, in patients chronically infected with HCV genotype 1 who had a prior null response to peginterferon alfa and ribavirin treatment. The study is planned to start in the second half of 2011.
"We are excited to be working with Tibotec to simplify and improve HCV treatment," stated Bill Symonds, PharmD, Pharmasset's Senior Vice President of Clinical Pharmacology and Translational Medicine. "PSI-7977 is now being studied in interferon-free combinations with each of the three leading classes of direct-acting antivirals: Tibotec's protease inhibitor, Bristol-Myers Squibb's NS5a inhibitor, and our own nucleotide, PSI-938. This advances one of our key goals at Pharmasset: to develop our nucleotide analogs as the backbone of interferon-free HCV therapy."
