Vertex completed enrollment for the two Phase 3 studies of the next-generation corrector VX-659 in triple combination with tezacaftor and ivacaftor in people with cystic fibrosis with one F508del mutation and one minimal function mutation and in people with two F508del mutations. Vertex expects to report data from both Phase 3 studies of the VX-659 triple combination regimen in late 2018. Vertex expects to complete enrollment of the two Phase 3 studies of the next-generation corrector VX-445 in triple combination with tezacaftor and ivacaftor in Q4 and to report data from these studies in 1Q19. Vertex plans to evaluate data from both the VX-659 and VX-445 Phase 3 triple combination programs to choose the best regimen to submit for potential regulatory approval. The data expected in late 2018 for VX-659 and in 1Q19 for VX-445 are expected to provide the basis for submission of a New Drug Application to the FDA for people with one F508del mutation and one minimal function mutation no later than mid-2019. Vertex expects to disclose in late 2018 and 1Q19 only the topline results for the primary 4-week efficacy endpoints of the VX-659 and VX-445 Phase 3 studies, respectively, and whether the safety and efficacy profiles observed support a potential NDA submission. In 2H19, Vertex intends to disclose additional safety and efficacy data, including secondary endpoints, for each study following the completion of both the VX-659 and VX-445 Phase 3 triple combination programs.
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