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news.Vertex Pharmaceuticals has announced the positive data from a Phase 2a study of the investigational selective oral JAK3 inhibitor VX-509 in rheumatoid arthritis (RA).
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The double-blind, randomized, placebo-controlled Phase 2a study of VX-509 enrolled 204 people with active moderate to severe RA.
The study evaluated four dose levels of VX-509, which was given twice daily (BID) for 12 weeks.
The study met its two primary endpoints, which were the proportion of people who achieved an ACR20 response at week 12 and the change from baseline in DAS28 at week 12.
Additional secondary endpoints were used to evaluate the clinical activity of VX-509, including ACR50 and ACR70 responses at week 12, DAS28 remission and EULAR response.
The responses observed in the two highest dose groups for VX-509 indicated continuous and statistically significant improvements in the signs and symptoms of RA.