Vertex Pharmaceuticals announced separate non-exclusive collaborations with Janssen Pharmaceuticals, and with GlaxoSmithKline, to evaluate its HCV drug candidate VX-135, in Phase II studies in combination with Janssen’s Phase III-stage protease inhibitor simeprevir (TMC435), and with GSK’s investigational NS5A inhibitor GSK2336805.
VX-135 is a uridine nucleotide analogue HCV polymerase inhibitor prodrug that acts on the NS5B polymerase to block HCV replication. The firm is already on track to start all-oral Phase II trials evaluating the drug in combination with ribavirin, and with telaprevir, within the next few months. FDA approved Vertex’ oral HCV drug Incivek™ (telaprivir) back in May 2011.
Under terms of the deal with Janssen, a Phase II proof-of-concept study is expected to start during early 2013 to test the safety, tolerability, and viral cure rates of 12 weeks of therapy using oral VX-135 combined with oral simeprevir, either with or without ribavirin, in treatment-naive patients with chronic, non-cirrhotic genotype 1 HCV. Vertex and Janssen will share associated costs.
The collaboration with GSK will involve a similarly designed Phase II proof-of-concept study evaluating VX-135 in combination with GSK’s GSK2336805. The trial will be conducted by Vertex in the U.S., and costs will be shared with GSK.
Simeprevir is a once-daily HCV protease inhibitor in late-stage development by Janssen R&D and Medivir. The drug is also being evaluated in Phase III trials as combination therapy with PEGinterferon/ribavirin, and in Phase II interferon-free studies in combination with direct-acting antiviral agents with and without ribavirin.