Gilead, Galapagos NV announce Phase 2 study meets primary endpoint

Gilead (GILD) and Galapagos NV (GLPG) announced that the randomized, placebo-controlled Phase 2 EQUATOR study of filgotinib, an investigational, selective JAK1 inhibitor, in 131 adults with moderate to severe psoriatic arthritis, achieved its primary endpoint of improvement in the signs and symptoms of psoriatic arthritis at Week 16, as assessed by the American College of Rheumatology 20% improvement score. There was an ACR20 response of 80% for filgotinib versus 33% for placebo. The ACR50 and ACR70 responses at Week 16 were also significantly higher for filgotinib versus placebo 48% for filgotinib versus 15%; ACR70: 23% versus 6 percent. Filgotinib was generally well-tolerated in the EQUATOR trial, with no new safety signals observed and similar laboratory changes compared to those reported in previous trials with filgotinib in rheumatoid arthritis patients. The adverse event rate was similar in both groups with mostly mild or moderate events reported. There was one serious infection in the filgotinib group, a patient who experienced pneumonia with a fatal outcome. One other patient receiving filgotinib developed herpes zoster. There were no cases of opportunistic infection, tuberculosis, thromboembolism, or malignancy.

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