November 1, 2012
Medivir AB (OMX: MVIR),
- Companies to evaluate a two-drug combination of Medivir/Janssen's investigational protease inhibitor simeprevir (TMC435) and Vertex's investigational nucleotide analogue VX-135
- Phase II proof-of-concept study to begin in early 2013 to evaluate safety, tolerability and viral cure rates of 12-week treatment regimen
announced today plans for a phase II proof-of-concept study of an all-oral regimen for the treatment of hepatitis C containing of Medivir/Janssen's protease inhibitor simeprevir and Vertex's nucleotide analogue hepatitis C virus (HCV) polymerase inhibitor VX-135. Janssen will conduct a drug-drug interaction study with simeprevir and VX-135 to support the planned initiation of a phase II proof-of-concept study in early 2013, pending discussions with regulatory authorities.
The phase II study is expected to evaluate safety, tolerability and viral cure rates using a 12-week combination of simeprevir and VX-135, with and without ribavirin. Janssen and Vertex will jointly fund development costs associated with the collaboration. There are no up-front or milestone payments associated with the agreement.
Simeprevir is a potent, once-daily investigational hepatitis C protease inhibitor, currently in phase III trials, being jointly developed by Medivir AB and Janssen R&D Ireland. VX-135 is an investigational uridine nucleotide analogue pro-drug designed to inhibit the replication of the hepatitis C virus by acting on the NS5B polymerase.
"This study will broaden our understanding of simeprevir, which we believe has the necessary characteristics to become a key component of future hepatitis C treatment regimens, including combination with interferon and ribavirin as well as interferon-free therapies and is in line with Medivir's and Janssen's strategy to evaluate different interferon-free HCV treatment possibilities" comments
, EVP of Research and Development, Medivir AB.
Clinical development plans