Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced it has entered into a non-exclusive agreement with GlaxoSmithKline (GSK) to conduct a Phase 2 proof-of-concept study of an all-oral regimen for the treatment of hepatitis C containing Vertex’s nucleotide analogue hepatitis C virus (HCV) polymerase inhibitor VX-135 and GSK’s NS5A inhibitor GSK2336805. Vertex and GSK plan to initiate the study in early 2013, pending discussions with regulatory authorities. The study is expected to evaluate safety, tolerability and viral cure rates using a 12-week combination of VX-135 and GSK2336805. The companies will jointly fund costs associated with the study. There are no up-front or milestone payments associated with the agreement. 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. GSK2336805 is an investigational NS5A replication complex inhibitor being developed by GSK for the treatment of hepatitis C.
“This agreement underscores our broad commitment to develop all-oral treatment regimens for people with hepatitis C using medicines within our own pipeline and by working in collaboration with other companies like GSK who share our commitment to further improve treatment of this disease,” said Robert Kauffman, M.D., Ph.D., Senior Vice President and Chief Medical Officer at Vertex. “We are focused on the development of new all-oral treatments for hepatitis C that have the potential to provide a high cure rate with only 12 weeks of treatment, and we look forward to the start of this study with GSK.”
Clinical Development Plans
The Phase 2 proof-of-concept study is expected to begin in early 2013, pending discussions with regulatory authorities, and will enroll people who have chronic non-cirrhotic genotype 1 hepatitis C and have not previously been treated (treatment-naïve). The study will be conducted in the U.S. by Vertex, and costs associated with the study will be split equally between the two companies. The goals of the study will be to evaluate safety, tolerability and viral cure rates (SVR12; undetectable hepatitis C virus 12 weeks after the end of treatment) of multiple 12-week combination regimens of VX-135 and GSK2336805, with and without ribavirin. Additional information on the Phase 2 study will be provided upon initiation of the study. Further clinical development activities beyond the Phase 2 proof-of-concept study are not covered as part of this agreement.