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).
STATEMENTS IN THIS COMPANY PRESS RELEASE MAY CONSTITUTE FORWARD-LOOKING
STATEMENTS AND ARE SUBJECT TO NUMEROUS RISKS AND UNCERTAINTIES, INCLUDING
THE FAILURE OF R7128 TO PERFORM AS EXPECTED, THE COMPANY'S ABILITY TO
ATTRACT AND RETAIN QUALIFIED PERSONNEL TO CONDUCT THE REQUIRED CLINICAL
TRIALS OF R7128 , THE STATUS OF THE COMPANY'S HCV COLLABORATION WITH ROCHE,
THE COMPANY'S FUTURE CAPITAL NEEDS TO FUND THE R7128 DEVELOPMENT PROGRAMS,
THE COMPANY'S ABILITY TO OBTAIN ADDITIONAL FINANCING, THE COMPANY'S ABILITY
TO OBTAIN REQUIRED REGULATORY APPROVALS FOR R7128, THE DEVELOPMENT OF
COMPETITIVE HCV PRODUCTS BY OTHERS, THE EXISTENCE OF THIRD-PARTY PATENT
RIGHTS, AND OTHER RISKS INHERENT IN DISCOVERY AND DEVELOPMENT STAGE
PROGRAMS AT A BIOTECHNOLOGY COMPANY. THE ACTUAL RESULTS FOR R7128 MAY
DIFFER MATERIALLY FROM THOSE ANTICIPATED IN THIS COMPANY PRESS RELEASE. THE
COMPANY DISCLAIMS ANY OBLIGATION TO UPDATE THE STATEMENTS CONTAINED IN THIS
COMPANY PRESS RELEASE.
Pharmasset, Inc.
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