Pharmasset, Inc. Initiates Phase 1 Study Of R7128 For HCV
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.
"We have jointly advanced this program from its discovery in our laboratories into the clinic," stated Schaefer Price, President & CEO of Pharmasset. "We are hopeful that R7128's excellent in vitro potency will translate into clinical benefits for patients with chronic hepatitis C, because we believe that polymerase inhibitors have the potential to become an important component of HCV combination therapy."
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 HCV
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 HCV. The CDC has reported that almost four million people in the United States have been infected with HCV, of whom 2.7 million were chronically infected.
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.
Contact: Alan Roemer Vice President, Finance & Investor Relations firstname.lastname@example.org Office: (609) 613-4125
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
CONTACT: Alan Roemer, Vice President, Finance & Investor Relations,+1-609-613-4125, email@example.com
Web site: http://www.pharmasset.com/