Simeprevir (TMC435) and TMC647055
Simeprevir is a once daily potent HCV NS3/4A protease inhibitor
TMC647055 is a potent NNI (non-nucleoside inhibitor) of the HCV NS5B polymerase
Also See - Simeprevir, TMC647055 and IDX719
AASLD- Data from Phase 2B Trials of Simeprevir (TMC435) in Hepatitis C Patients with Advanced Fibrosis
Janssen Pharmaceuticals, Inc. (Janssen) today announced that the use of one once-daily pill of the investigational protease inhibitor simeprevir (TMC435) administered with pegylated interferon and ribavirin led to higher rates of sustained viral response at 24 weeks (SVR24) compared to placebo in patients with Metavir scores of F3 and F4 who were treatment naive and treatment experienced with genotype 1 hepatitis C. Simeprevir was also generally well tolerated and the overall incidence of serious adverse events (AEs) was similar across all treatment arms. The data from the Phase 2b PILLAR and ASPIRE trials
were presented at the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD)...
Simeprevir, an investigational NS3/4A protease inhibitor jointly developed by Janssen and Medivir, is currently in Phase 3 studies as a once-daily treatment taken in combination with pegylated interferon and ribavirin for the treatment
of genotypes 1 and 4 chronic hepatitis C. It is also being studied in separate Phase 2 trials with other direct-acting antiviral agents as part of interferon-free regimens, with and without ribavirin. This includes a recently initiated Phase 2a trial of an interferon-free regimen with simeprevir and TMC647055, Janssen's non-nucleoside polymerase inhibitor (NNI) currently in
development for hepatitis C.....
TMC435 (Simeprevir)-Promising New Oral Therapy for Hepatitis C
Simeprevir (TMC435) Data In Hepatitis C To Be Presented At The AASLD
A Phase IIa Interferon Free Combination Hepatitis C Trial of Simeprevir (TMC435) and TMC647055 Will Commence Shortly
STOCKHOLM, September 20,
2012 /PRNewswire/ --
Medivir AB (OMX: MVIR), announced today that simeprevir (TMC435) and TMC647055, a non-nucleoside inhibitor (NNI) will enter a phase IIa interferon free combination trial. Simeprevir is a once daily potent HCV NS3/4A protease inhibitor in phase III clinical development for the treatment of chronic hepatitis C jointly developed by Medivir and Janssen Research &
Development Ireland (Janssen). TMC647055 is a potent NNI (non-nucleoside inhibitor) of the HCV NS5B polymerase and is being developed by Janssen R&D.
"This study is in line with Medivir's and Janssen's strategy to evaluate different combination possibilities with simeprevir for interferon-free HCV treatments. This will broaden our understanding of simeprevir, which we believe has the necessary characteristics to potentially become a key component of future hepatitis C treatment regimens, including combination with interferon and ribavirin as well as interferon-free therapies," comments Charlotte Edenius, Medivir's EVP of Research and Development.
Study designThis will be an open label study in patients who are chronically infected with HCV genotype-1a or 1b to
assess the efficacy, safety and tolerability of the combination. The primary endpoint in the study will be SVR12 (sustained virologic response 12 weeks after end of treatment). Simeprevir, TMC647055 and low-dose ritonavir will be
co-administered once daily, with and without ribavirin.
Approximately 40 patients will be enrolled in this study, which is divided in two parts. The first part will include patients chronically infected with HCV genotype-1, who are either treatment-naive or have relapsed after prior pegylated interferon
(PegIFN)/ribavirin treatment. The treatment will consist of simeprevir, TMC647055 and low-dose ritonavir, with and without ribavirin for 12 weeks.
The second part of the trial will investigate the same regimen in prior null responder patients chronically infected with HCV genotype 1a.
Additional information about this study will be posted on http://www.clinicaltrials.gov
About MedivirMedivir is an emerging research-based pharmaceutical company focused on infectious diseases. Medivir
has world class expertise in polymerase and protease drug targets and drug development which has resulted in a strong infectious disease R&D portfolio.
The Company's key pipeline asset is simeprevir (TMC435), a novel protease inhibitor in phase III clinical development for hepatitis C that is being developed in collaboration with Janssen Research & Development Ireland.
In June 2011, Medivir acquired the specialty pharmaceutical company BioPhausia. and today Medivir has a broad
product portfolio with prescription pharmaceuticals in the Nordics.
Medivir's first product, the unique cold sore product Xerese®/Xerclear®, is launched in collaboration with GlaxoSmithKline to be sold OTC under the brand name ZoviDuo in Europe, Japan and Russia.
Medivir's IPO was in 1996 and currently the company has around 180 employees.
For more information about Medivir, please visit the Company's website: http://www.medivir.com
For more information
about Medivir, please contact:
Rein Piir, EVP
Corporate Affairs & IR
Direct: +46-8-440-6550 or:
Elliott, Amber Bielecka, Hollie