Vertex Pharmaceuticals has announced agreements with GlaxoSmithKline (GSK) and Janssen for the conduct of Phase II proof-of-concept studies of all-oral regimens for the treatment of hepatitis C.
The study agreed with GSK is expected to evaluate safety, tolerability and viral cure rates using a 12-week combination of VX-135 and GSK’s non-structural 5A (NS5A) inhibitor GSK2336805, with and without ribavirin. GSK2336805 is an investigational NS5A replication complex inhibitor being developed by GSK for the treatment of hepatitis C.
The studies will enrol people who have chronic non-cirrhotic genotype 1 hepatitis C and who have not previously been treated. The study involving GSK2336805 will be conducted in the US by Vertex. Additional information on the studies will be provided upon their initiation, but further clinical development beyond the Phase II proof-of-concept study are not covered as part of either agreement.
Vertex gained worldwide rights to VX-135 through an exclusive licensing agreement signed with Alios BioPharma in June 2011. The agreement also includes a research programme that will focus on the discovery of additional nucleotide analogues that act on hepatitis C polymerase. Vertex has the option to select additional compounds for development emerging from the research programme.
While chronic hepatitis C can be cured, around 60% of patients do not achieve viral cure after treatment with 48 weeks of pegylated-interferon and ribarivin alone, says Vertex.
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