Gilead Sciences and Galapagos NV announced additional efficacy and safety results through 52 weeks from the phase 3 FINCH 1 and FINCH 3 trials of filgotinib for the treatment of moderate-to-severe rheumatoid arthritis. Filgotinib is an investigational, oral selective JAK1 inhibitor.
Findings from both studies at week 52 demonstrated filgotinib to have a consistent efficacy, safety, and tolerability profile with that observed at weeks 12 and 24, which were previously presented in March 2019. Results at weeks 12 and 24 showed that patients treated with filgotinib achieved statistically significant American College of Rheumatology 20% response (ACR20) compared with placebo.
Full detailed results from both studies at Week 52 will be submitted for presentation at a future medical conference. The Companies plan to file a New Drug Application (NDA) for filgotinib for the treatment of rheumatoid arthritis in late 2019.
Additionally, filgotinib is currently being investigated for several inflammatory indications, including the EQUATOR phase 2 program in psoriatic arthritis, the TORTUGA phase 2 study in ankylosing spondylitis, the DIVERSITY phase 3 trial in Crohn disease (also small bowel and fistulizing Crohn disease phase 2 studies) and the phase 3 SELECTION trial in ulcerative colitis.
“These recent updates from the FINCH 1 and 3 trials continue to provide consistent evidence to support filgotinib’s profile in RA patients. In the second half of the FINCH 1 and FINCH 3 trials, filgotinib exhibited the same favorable safety profile seen in the first 24 weeks, including similar rates of thrombotic events as previously observed, as well as persistent efficacy,” said Dr. Walid Abi-Saab, Chief Medical Officer, Galapagos.