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
“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.
This 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
Medivir 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
Medivir’s first product, the unique cold sore product Xerese(R)/Xerclear(R), 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:
For more information about Medivir, please contact: Medivir Rein Piir, EVP Corporate Affairs & IR Direct: +46-8-440-6550 or: Mobile: +46-708-537-292 M:Communications Europe: Mary-Jane Elliott, Amber Bielecka, Hollie Vile email@example.com +44(0)20-7920-2330