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Pharmasset Reports Positive Results from its HCV Clinical Programs
Date:1/6/2011

t, treatment-emergent trends in any clinical laboratory parameters

PSI-938 demonstrated potent antiviral activity with a median HCV RNA change from baseline of 5.23 log10 IU/mL in the 8 patients receiving 300mg QD monotherapy for 14 days. HCV RNA declined rapidly and consistently throughout the 14 day dosing period, with no viral breakthrough noted. In the 8 subjects who received PSI-938 300mg QD monotherapy for 14 days, half (4 of 8) of the subjects achieved HCV RNA below the limit of detection (15 IU/mL), and 5 of 8 patients achieved HCV RNA below the limit of quantification (43 IU/mL). The median baseline HCV RNA in patients enrolled in Part 2 was approximately 1 log10 higher than in the Part 1 multiple ascending dose trial (6.95 log10 IU/mL versus 5.92 log10 IU/mL), allowing for a full assessment of the antiviral activity of the nucleotide analog.

Patients are now being enrolled in the second and third cohorts. Patients will receive monotherapy with either PSI-938 or PSI-7977 for days 1-7, followed by the combination of PSI-938 plus PSI-7977 for days 8-14. Following availability of data from these initial combination cohorts, the fourth and final cohort will receive both PSI-938 and PSI-7977 for 14 days. We anticipate reporting further data from this study during this quarter. In addition, we plan on initiating a Phase 2 study of PSI-938 in combination with PSI-7977 during mid-2011. This Phase 2 study will explore multiple treatment durations of PSI-938 and PSI-7977 with an SVR endpoint.

"We are encouraged by the initial results generated with PSI-7977 in combination with Peg-IFN/RBV over 12 weeks and with PSI-938 monotherapy over 14 days," stated Michelle Berrey, MD, MPH, Chief Medical Officer. "Both programs are progressing on schedule and we anticipate reporting further efficacy, safety and resistance data throughout 2011. We are excited to be moving PSI-938 into the combination phase of this study with PSI-7977, as this may provide
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SOURCE Pharmasset, Inc.
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