Pharmasset Inc., in Princeton, New Jersey, received a fast-track designation from the U.S. Food and Drug Administration (FDA) for its drug PSI-7977, developed for the treatment of chronic hepatitis C virus (HCV) infection.
PSI-7977 is an oral nucleotide analog inhibitor of HCV. Pharmasset recently completed dosing in a Phase 2a trial to evaluate PSI-7977 in combination with standard therapies in treatment-naive patients chronically infected with HCV genotype 1, which affects some 75 percent of HCV patients.
The company says FDA granted PSI-7977 the fast-track designation due to the need for new HCV treatments, with improved safety and efficacy over existing treatments for both new patients and those who have been exposed to other treatments. Pharmasset expects to start a 12-week Phase 2b study of PSI-7977, to study its efficacy, in the fourth quarter of 2010.
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