- Category: HCV Treatment
- Published on Friday, 02 November 2012 00:00
- Written by Press Release
Vertex Pharmaceuticals this week announced that it has made separate agreements with Janssen Pharmaceuticals and GlaxoSmithKline (GSK) to evaluate all-oral regimens containing its HCV polymerase inhibitor VX-135 (also known as ALS-2200) for previously untreated genotype 1 chronic hepatitis C patients.
The advent of direct-acting agents that target different steps of the hepatitis C virus (HCV) lifecycle has ushered in a new treatment paradigm. But the 2 drugs approved so far -- Vertex's HCV protease inhibitor telaprevir (Incivek) and Merck's boceprevir (Victrelis) -- must be used with pegylated interferon and ribavirin. Due to its difficult side effects, many people with hepatitis C and their providers are eagerly awaiting interferon-free regimens.
Vertex and its collaborator Alios BioPharma recently released data from a viral kinetics study showing that VX-135 monotherapy demonstrated potent antiviral activity over 7 days and was generally well-tolerated. At that time Vertex said it plans to start a study of VX-135 plus ribavirin by the end of 2012 and VX-135 plus telaprevir in early 2013.
On November 1 Vertex announced a non-exclusive agreement with
Janssen to test VX-135, a uridine nucleotide analog prodrug, in combination with Janssen's investigational HCV protease inhibitor simeprevir (TMC435).
Data presented at the EASL International Liver Congress this past April showed that simeprevir -- now in Phase 3 studies -- produced impressive cure rates in combination with pegylated interferon/ribavirin for genotype 1 hepatitis C patients who did not respond to previous treatment.
The new Phase 2 proof-of-concept study, expected to begin in early 2013, will evaluate the safety, tolerability, and efficacy of all-oral regimens of VX-135 plus simeprevir, with or without ribavirin, for 12 weeks in previously untreated genotype 1 chronic hepatitis C patients without liver cirrhosis. As part of the collaboration, Janssen will conduct a drug-drug interaction study with VX-135 and simeprevir.
Vertex also announced that it will collaborate with GSK to test VX-135 in an interferon-free combination with the experimental NS5A inhibitor GSK2336805. This Phase 2 proof-of-concept study, also slated for early 2013, will look at the safety and efficacy of VX-135 plus GSK2336805, with or without ribavirin, for 12 weeks, again for treatment-naive, non-cirrhotic genotype 1 patients.
Vertex Pharmaceuticals. Vertex Announces Collaboration with Janssen To Initiate Phase 2 All-Oral Study of VX-135 and Simeprevir (TMC435) for the Treatment of Hepatitis C. Press release. November 1, 2012.
Vertex Pharmaceuticals. Vertex Enters Agreement with GlaxoSmithKline for Phase 2 All-Oral Study of VX-135 and GSK2336805 for the Treatment of Hepatitis C. Press release. November 1, 2012.