Vertex Pharmaceuticals has announced the planned initiation of two Phase 2 studies to evaluate the next-generation correctors VX-440 and VX-152 in triple combination regimens with tezacaftor (VX-661) and ivacaftor in people with cystic fibrosis (CF).
The first data from this study are expected in the second half of 2017 and are intended to support the initiation of Phase 3 development for VX-440 and the initiation of a longer-duration Phase 2b or registrational program for VX-152.
Vertex said that it has submitted Investigational New Drug applications to the U.S. Food and Drug Administration (FDA) for both VX-440 and VX-152 and expects to start both studies by the end of 2016.
Vertex also announced today that it plans to begin Phase 1 development of an additional next-generation corrector, VX-659, by the end of 2016. Based on data from this study, Vertex plans to start a Phase 2 study of VX-659 in the second half of 2017. The company also expects to advance a fourth next-generation corrector into Phase 1 development in 2017.
“We are committed to advancing multiple next-generation correctors in parallel to bring the best potential treatments to all people with CF who have at least one F508del mutation,” said Jeffrey Chodakewitz, M.D., Executive Vice President and Chief Medical Officer at Vertex. “We believe that the combination of a next-generation corrector with tezacaftor and ivacaftor has the potential to benefit a broad range of people with this disease, including those with minimal function mutations who do not yet have a medicine to treat the underlying cause of their CF.”, added Chodakewitz.
“KALYDECO and ORKAMBI are significant medical advances for many people with CF, however a very large number of our patients still do not have medicine to treat the cause of their disease,” said Patrick Flume, M.D., Director of the Medical University of South Carolina Cystic Fibrosis Center and Principal Investigator for the Phase 2 VX-152 study. Flume continued: “The studies announced today are a promising step forward for patients and for the treatment of this devastating disease. I look forward to working with Vertex to move these potential medicines through development and toward patients as rapidly as possible.”