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New HCV Drug R7128 Polymerase Inhibitor
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Pharmasset Initiates Multiple Ascending Dose Study of R7128 in Patients Chronically Infected With HCV Genotype 1
SOURCE Pharmasset, Inc.
PRINCETON, N.J., Feb. 28 /PRNewswire/ -- Pharmasset initiated the
multiple ascending dose portion of an on-going Phase 1 clinical trial evaluating R7128 in up to 40 patients chronically infected with hepatitis C virus (HCV) genotype 1. The primary objective of this part of the study, being conducted in collaboration with Roche, is to assess the safety, tolerability and pharmacokinetics of multiple doses of R7128 after once-daily or twice-daily dosing for 14 days. The secondary objective is to assess antiviral efficacy of R7128 by measuring the decrease in HCV viral load. As a result of the initiation of the multiple ascending dose portion of this study, Pharmasset triggered a $5.0 million milestone payment from Roche.
Pharmasset and Roche recently completed part 1 of this Phase 1 study in 38 healthy volunteers who received single ascending doses of R7128. The effect of food on R7128 was also assessed. Preliminary data from the single ascending dose portion of the study indicate:
- All doses of R7128 studied were generally well-tolerated.
- All patients completed the study, and none experienced gastrointestinal
adverse events or serious adverse events during the study.
- No hematological or laboratory abnormalities of clinical significance
were noted.
The preliminary safety and pharmacokinetic data from part 1 of the study supported progression of R7128 into part 2 of the study in patients chronically infected with HCV genotype 1.
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 HCV 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 chronically infected with HCV genotype 1. This study is 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 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 40
patients chronically infected with HCV genotype 1. The primary
objective of Part 2 is to assess the safety, tolerability and
pharmacokinetics of R7128 after once-daily or twice-daily dosing for 14
days. The secondary objective is to assess antiviral efficacy by
measuring the decrease in HCV viral load.
About Hepatitis C
Hepatitis C is a blood-borne infectious disease of the liver and is a leading cause of chronic liver disease and liver transplants. The WHO estimates that nearly 180 million people worldwide, or approximately 3% of the world's population, are infected with hepatitis C virus (HCV). The CDC has reported that almost four million people in the United States have been infected with HCV, of whom 2.7 million are chronically infected.
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 B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV).
Contact:
Alan Roemer
Vice President, Investor Relations & Corporate Communications
alan.roemer@pharmasset.com
Office: (609) 613-4125
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