Pharmasset Reports Positive Preliminary Antiviral Data With PSI-7851 for the Treatment of H...( ...),Health

PRINCETON, N.J., July 31 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq: VRUS) reported today positive preliminary results from its phase I clinical trial of PSI-7851 for the treatment of hepatitis C (HCV). PSI-7851 is a second generation nucleotide polymerase inhibitor of HCV.

PSI-7851 Phase 1 Multiple Ascending Dose Study Overview

In June 2009, Pharmasset initiated a phase 1 multiple ascending dose study with PSI-7851. The trial was conducted at two US centers, as a blinded, randomized, and placebo-controlled study, in 30 patients chronically infected with HCV genotype 1. The primary objective was to assess the safety, tolerability, and pharmacokinetics of PSI-7851 after once-daily (QD) dosing for 3 days. The secondary objective was to assess antiviral activity by measuring the change in HCV RNA. Patients were randomized to receive either PSI-7851 (8 patients per cohort) or placebo (2 patients per cohort). Three dose cohorts of PSI-7851 (50mg QD, 100mg QD, 200mg QD) were evaluated.

PSI-7851 Antiviral Activity Summary

    Preliminary Antiviral Response Observed Following PSI-7851 Administered as
                                 Monotherapy for 3 Days
    --------------------------------------------------------------------------
    Dose                 N                     Mean Change in HCV RNA at Day 3
                                                            (Log(10))
    --------------------------------------------------------------------------
    50mg QD              8                                   -0.49
    100mg QD             8                                   -0.61
    200mg QD             8                                   -1.01
    Placebo              6                             
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SOURCE  Pharmasset, Inc.
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