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Janssen Announces Data from Simeprevir in Hepatitis C Patients Will Be Presented at The International Liver Congress of the European Association for the Study of the Liver (EASL)
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CORK, Ireland, April 8, 2013 /PRNewswire/ --Janssen R&D Ireland (Janssen) announces that data will be presented on the investigational protease inhibitor simeprevir (TMC435) for the treatment of hepatitis C at The International Liver Congress 2013 of the European Association for the Study of the Liver (EASL), which will take place April 24 to 28 in Amsterdam, The Netherlands. These data presentations will include primary efficacy and safety results from the Phase 3 QUEST-1 study of simeprevir administered once daily in combination with pegylated interferon and ribavirin in treatment-naive genotype 1 chronic hepatitis C patients.
"The presentation of this primary efficacy Phase 3 data in a peer-reviewed setting such as The International Liver Congress represents a significant milestone for simeprevir," said Maria Beumont, M.D., medical leader for simeprevir, Janssen. "These data show the potential utility of simeprevir for people living with hepatitis C."
Janssen recently announced the submission of new drug applications in Japan and the United States for simeprevir administered once daily in combination with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C in adult patients and anticipates submitting simeprevir for regulatory authorization in the EU in the first half of 2013. Simeprevir is also being studied in combination with pegylated interferon and ribavirin for the treatment of genotype 4 HCV infection and in several interferon-free regimens using selected combinations of direct-acting antiviral agents with different mechanisms of action.
Additional simeprevir data from the QUEST-2 study have been accepted by The International Liver Congress, but are subject to EASL's embargo policy until April 23. The data to be presented at The International Liver Congress 2013 include:
· Simeprevir (TMC435) with peginterferon/ribavirin for chronic HCV genotype-1 infection in treatment-naive patients: results from QUEST-1, a Phase III trial
Available Thursday, April 25 - Saturday, April 27
Lead Author: Ira Jacobson, chief of the Division of Gastroenterology and Hepatology, Vincent Astor Distinguished Professor of Medicine, Weill Cornell Medical College, and attending physician, New York-Presbyterian Hospital/Weill Cornell Medical Center
· Pharmacokinetics of simeprevir (TMC435) in volunteers with moderate or severe hepatic impairment
Available Friday, April 26
Lead Author: Sivi Ouwerkerk-Mahadevan, scientific director, Clinical Pharmacology, Janssen
· Improved SVR with simeprevir (TMC435) associated with reduced time with patient-reported fatigue in treatment-naive, HCV-infected patients in the PILLAR Phase IIb trial
Available Friday, April 26
Lead Author: Jane Scott, director, Patient Reported Outcomes, Janssen
· Adding simeprevir (TMC435) to pegylated interferon/ribavirin does not increase patient reported fatigue in treatment-experienced patients with chronic HCV infection: results from the ASPIRE trial
· Available Friday, April 26
· Lead Author: Jane Scott, director, Patient Reported Outcomes, Janssen
· Combination therapy of TMC647055 with simeprevir (TMC435) in genotype 1 HCV patients
Lead Author: Stefan Bourgeois, gastroenterologist, ZNA
Stuivenbergziekenhuis
Full session details and data presentation listings for The International Liver Congress 2013 can be found at http://www.easl.eu.
About Simeprevir
Simeprevir (TMC435) is an investigational NS3/4A protease inhibitor jointly developed by Janssen and Medivir AB for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease. Simeprevir works by blocking the protease enzyme that enables the hepatitis C virus to survive and replicate in host cells. Janssen recently announced the submission of new drug applications for simeprevir in Japan and the United States for the treatment of genotype 1 hepatitis C.
Global Phase 3 studies of simeprevir include QUEST-1 and QUEST-2 in treatment-naive patients, PROMISE in patients who have relapsed after prior interferon-based treatment and ATTAIN in null-responder patients.In parallel to these trials, Phase 3 studies for simeprevir are ongoing in treatment-naive and treatment-experienced HIV-HCV co-infected patients and HCV genotype 4 patients. To date, 1,846 patients have been treated with simeprevir in clinical trials.
Simeprevir is also being studied in Phase 2 interferon-free trials with and without ribavirin in combination with:
· Janssen's non-nucleoside inhibitor TMC647055 and ritonavir in treatment-naive genotype 1a and 1b HCV patients; and
· Gilead Sciences, Inc.'s nucleotide inhibitor sofosbuvir (GS-7977) in treatment-naive and previous null-responder genotype 1 HCV patients
In addition, Janssen has entered into a non-exclusive collaboration with Vertex Pharmaceuticals to evaluate in a Phase 2 study the safety and efficacy of an all-oral regimen of simeprevir and Vertex's investigational nucleotide analogue polymerase inhibitor VX-135 for the treatment of HCV. Janssen also has plans to initiate a Phase 2 trial of an investigational interferon-free regimen with simeprevir, TMC647055 and Idenix's IDX719, a once-daily, pan-genotypic NS5A inhibitor, with and without ribavirin.
For additional information about simeprevir clinical trials, please visit www.clinicaltrials.gov.
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