Published on September 21, 2012 at 2:51 AM
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
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.