Medivir announces interferon-free phase IIa trial with HCV PI plus investigational non-nuc...

Press release  posted 9/20 on PR Newswire. Medivir announces a Phase IIa trial pairing it's HCV NS3/4A protease inhibitor simeprevir (TMC435) with Janssen's non-nuc TMC647055 and ritonovir (a potent CYP P450 inhibitor) with and without ribavirin in treatment naive, relapser genotype 1 patients as well as the difficult-to-treat genotype 1a null responder population. The latter population is incredibly important, as the efficacy with current anti-HCV regimens is notoriously low. The addition CYP P450 inhibitor ritonavir is used in regimens to block metabolism of the active molecule(s) leading me to believe that TMC435 may effect the drug levels of TMC647055, or both. Ritonavir, unfortunately, also limits concomitant meds also metabolized by CYP P450.  

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 design
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 http://www.clinicaltrials.gov

About Medivir
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 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:

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  
medivir@mcomgroup.com
+44(0)20-7920-2330

SOURCE Medivir

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