Pharmasset Initiates Phase 2a Trial with PSI-7977, a Chirally Pure Isomer of PSI-7851
PRINCETON, N.J., Jan 21, 2010 /PRNewswire via COMTEX News Network/ -- Pharmasset, Inc. (Nasdaq: VRUS) today announces the initiation of a 28-day Phase 2a study with PSI-7977, a chirally pure isomer form of PSI-7851, a nucleotide analog polymerase inhibitor in development for the treatment of chronic hepatitis C (HCV). The trial will evaluate various doses of PSI-7977 in combination with Pegasys (peginterferon alfa 2a) and Copegus (ribavirin) in patients with HCV genotype 1 who have not been treated previously.
"We recently reported encouraging clinical results with PSI-7851," said Michelle Berrey, MD, MPH, Pharmasset's Chief Medical Officer. "We now believe there are a number of advantages in moving forward with a chirally pure isomer of PSI-7851, PSI-7977, including improvements in manufacturing. We look forward to reporting interim data from the Phase 2a trial in the third quarter of 2010, and hope to rapidly progress PSI-7977 into longer-term studies to demonstrate the safety and efficacy of the nucleosides/tides in all HCV genotypes."
About PSI-7977
PSI-7851 is a mixture of two molecules of identical chemical composition, PSI-7976 and PSI-7977, which only differ in the stereo-orientation of one of the atoms. Once inside a liver cell, both molecules are rapidly converted to the same active triphosphate. Given the greater improvements in manufacturing and better in vitro potency, PSI-7977 was selected for further clinical development. A superior formulation in the form of a tablet has been developed and has recently been evaluated in a Phase 1 study in healthy volunteers. The 28 day Phase 2a trial using the improved manufacturing process and tablet formulation has now been initiated and interim results from this study are anticipated in the third quarter of 2010.
About the Phase 2a trial
The Phase 2a trial is expected to enroll about 60 patients with chronic hepatitis C infection who have not been treated previously. The primary goal of the study is to determine the safety and tolerability of PSI-7977 in combination with pegylated interferon and ribavirin. The primary efficacy endpoint of the trial will be the proportion of patients who achieve a rapid virologic response (RVR), defined as undetectable levels of HCV (measured by TaqMan assay) four weeks after the initiation of treatment. Patients will continue to be followed through a Sustained Virologic Response (SVR) endpoint. Patients will be randomized to receive one of four treatments:
PSI-7977 100mg QD in combination with Pegasys and Copegus for four weeks, followed by 44 weeks of Pegasys and Copegus
PSI-7977 200mg QD in combination with Pegasys and Copegus for four weeks, followed by 44 weeks of Pegasys and Copegus
PSI-7977 400mg QD in combination with Pegasys and Copegus for four weeks, followed by 44 weeks of Pegasys and Copegus
A control arm with Pegasys and Copegus