PRINCETON, N.J., Feb. 17 /PRNewswire-FirstCall/ -- Pharmasset, Inc. announced today the complete enrollment by Roche of the 12 week RG7128 Phase 2b study (PROPEL) of approximately 400 treatment-naive patients with hepatitis C virus (HCV) genotypes 1 and 4. The study remains blinded to Roche and Pharmasset.
In addition, Roche is planning to initiate a Phase 2b study of RG7128 in combination with pegylated interferon and ribavirin in patients with HCV genotypes 2 and 3 later in 2010. RG7128 has previously demonstrated antiviral activity with a 90% RVR in HCV genotypes 2 and 3 prior non-responders in a 28 day clinical study.
Modifications to the INFORM program will have no impact on the primary registration pathway for RG7128. In addition, Roche has indicated that it is evaluating the potential of combining RG7128 with non-protease complementary compounds.
About Pharmasset
Pharmasset is a clinical-stage pharmaceutical company committed to discovering, developing, and commercializing novel drugs to treat viral infections. Pharmasset’s primary focus is on the development of oral therapeutics for the treatment of hepatitis C virus (HCV) and, secondarily, on the development of Racivir(TM) for the treatment of human immunodeficiency virus (HIV). Our research and development efforts focus on nucleoside/tide analogs, a class of compounds which act as alternative substrates for the viral polymerase, thus inhibiting viral replication. We currently have three clinical-stage product candidates. RG7128, a nucleoside analog for chronic HCV infection, is in two Phase 2b clinical trials in combination with Pegasys(R) plus Copegus(R) and is also in the INFORM studies, the first series of studies designed to assess the potential of combinations of small molecules without Pegasys(R) and Copegus(R) to treat chronic HCV. These clinical studies are being conducted through a strategic collaboration with Roche. Our other clinical stage candidates include PSI-7977, an isomer of PSI-7851 and an unpartnered, next- generation HCV nucleotide analog that is in a Phase 2a trial; and Racivir, for the treatment of HIV, which has completed a Phase 2 clinical trial. We also have in our pipeline two purine nucleotide analogs, PSI-938 and PSI-879, in advanced preclinical development.
Pharmasset, Inc.
