Simeprevir and VX-135 Team Up in Phase II Hep C Trial
November 7, 2012
Phase II All-oral Study Of Simeprevir And VX-135 For The Treatment Of Hepatitis C
By News Staff | November 3rd 2012
Medivir AB has announced 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.
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