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news.Pharmasset has signed a clinical pact with Tibotec Pharmaceuticals to investigate the safety and efficacy of PSI-7977 in conjunction with Tibotec's TMC435 in a Phase 2 trial in chronic hepatitis C virus (HCV) patients.
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PSI-7977 is Pharmasset’s experimental nucleotide polymerase inhibitor and TMC435 is an experimental protease inhibitor of Tibotec.
In the trial, the companies expect to investigate the pharmacokinetics, safety and pharmacodynamics of PSI-7977 in conjunction with TMC435, with and without ribavirin in patinets with HCV genotype 1 who had a prior null response to peginterferon alfa and ribavirin treatment.
The study is expected to commence in the second half of 2011.
Pharmasset Clinical Pharmacology and Translational Medicine senior vice president Bill Symonds said PSI-7977 is now being studied in interferon-free combinations with each of the three classes of direct-acting antivirals: Tibotec’s protease inhibitor, Bristol-Myers Squibb’s NS5a inhibitor, and their own nucleotide, PSI-938.