Galapagos NV has recently initiated a global Phase 3 clinical program (FINCH) evaluating the safety and efficacy of filgotinib (100 mg and 200 mg once daily) in a range of people with rheumatoid arthritis (RA) — from early stage patients to those with active disease on biologic treatments.
Filgotinib is a selective inhibitor of the JAK1 (Janus kinase 1), an enzyme involved in the signaling pathways of several pro-inflammatory cytokines, ultimately leading to inflammation.
The FINCH program is composed of three clinical trials evaluating filgotinib in rheumatoid arthritis:
• FINCH 1 is 52-week a randomized, and placebo- and adulimumab-controlled study, in combination with methotrexate (MTX). A total of 1,650 RA patients who have had inadequate response to MTX are expected to enroll. Its primary endpoint is ACR20 (a measure of response to treatment in RA) at week 12. Radiographic disease progression assessments at weeks 24 and 52 will also be evaluated.
• FINCH 2 (NCT02873936) is 24-week randomized, placebo-controlled clinical trial involving 423 patients using conventional disease-modifying anti-rheumatic drugs (cDMARDs), who have had an inadequate response to these biological treatments. The trial’s primary endpoint is ACR20 response at week 12.
This trial is open and currently recruiting eligible patients. More information is available on the study’s clinical trials.gov website.
• FINCH 3 is a randomized clinical trial that will run for 52 weeks in 1,200 patients who are MTX-naïve. It will investigate filgotinib monotherapy combined with MTX. The trial’s primary endpoint is the ACR20 response to treatment at week 24. Radiographic disease progression will also be evaluated.
“The FINCH program, led by our collaboration partner Gilead Sciences, Inc., is designed to enable a comprehensive evaluation of 100 mg and 200 mg filgotinib once daily in early stage to biologic-resistant RA patient populations,” Piet Wigerinck, chief scientific officer at Galapagos, said in a press release. “Preparations are well underway to also initiate studies with filgotinib in Crohn`s disease and ulcerative colitis in [the final quarter] of this year.”
These three studies will run in Europe and the United States. Other world regions will follow.
Positive results were reported in a Phase 2 study of filgotinib, with researchers finding the drug was well-tolerated and that RA patients under filgotinib treatment had a statistically significant improvement of up to 80% in ACR20 scores in comparison to placebo.
Galapagos and Gilead are working together to develop and commercialize filgotinib for inflammatory conditions like rheumatoid arthritis.