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Pharmasset Initiates Phase-1 Study of R7128 for HCV

[This very early HCV program is partnered with Roche. The new drug candidate, R7128, is a prodrug of a polymerase inhibitor that was previously tested in a phase-1 study. This drug should not be confused with Roche’s in-house HCV polymerase inhibitor, R1676, which is now entering phase-2.]

http://biz.yahoo.com/prnews/061027/nyf043.html?.v=70

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Friday October 27, 7:00 am ET

PRINCETON, N.J., Oct. 27 /PRNewswire/ -- Pharmasset provided an update today on their collaboration with Roche to develop nucleoside polymerase inhibitors for the treatment of chronic hepatitis C virus (HCV) infections. Pharmasset initiated oral dosing of R7128 in a Phase 1 clinical trial being conducted under a U.S. FDA Investigational New Drug application. This study is designed to assess the safety and pharmacokinetics of R7128 in healthy volunteers, as well as provide antiviral potency data over 14-days in HCV- infected individuals.

…About R7128

R7128 is a polymerase inhibitor being developed for the treatment of chronic hepatitis C. R7128 is a prodrug of PSI-6130, which demonstrated excellent potency in preclinical studies. PSI-6130 is a pyrimidine nucleoside analog inhibitor of RNA polymerase, an enzyme that is necessary for hepatitis C viral replication. Results from an oral single ascending dose study in 24 healthy male volunteers showed that PSI-6130 was generally well tolerated with no serious adverse events in doses up to 3000 mg.

R7128 Phase 1 Study Overview

The Phase I clinical trial is a multiple center, observer-blinded, randomized and placebo-controlled study to investigate the pharmacokinetics, pharmacodynamics, safety, tolerability and food effect of R7128 in healthy volunteers and in patients with chronic HCV genotype 1 infection. This study will be comprised of two parts:

-- Part 1 is a single ascending dose study being conducted in up to 38 healthy volunteers. The primary objective of Part 1 is to assess the safety, tolerability and pharmacokinetics of R7128 in healthy volunteers following single ascending doses under fasting conditions. The secondary objective of Part 1 is to explore the effect of food on the pharmacokinetics of R7128.

-- Part 2 is a multiple ascending dose study being conducted in up to 48 patients infected with HCV genotype 1. The primary objective of Part 2 is to assess the safety, tolerability and pharmacokinetics of R7128 in HCV genotype 1-infected patients after once-daily or twice-daily dosing for 14 days. The secondary objective is to evaluate the decrease in HCV viral load.

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 human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV). For more information, please visit http://www.pharmasset.com.
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