Gilead Sciences and Galapagos’ filgotinib has met its primary and all significant secondary endpoints in a phase 3 study of rheumatoid arthritis.
The Finch 2 is a global, 24-week randomized, double-blind, placebo-controlled and phase 3 study of filgotinib in adults with moderately-to-severely active rheumatoid arthritis and prior inadequate response/intolerance to biologic agents.
Filgotinib is an investigational and selective JAK1 inhibitor, which is not yet approved anywhere across the globe. Its efficacy and safety were not established.
Gilead said the study reached its primary endpoint in the proportion of patients achieving an American College of Rheumatology 20% response (ACR20) at week 12.
The proportion of patients achieving ACR50 and ACR70 low disease activity and clinical remission have been significantly higher for patients securing once-daily filgotinib 100 mg or 200 mg compared to patients receiving placebo at weeks 12 and 24.
Gilead Sciences research and development head and chief scientific officer John McHutchison said: “Gilead is committed to the development of new therapies that offer meaningful benefit for people living with rheumatoid arthritis and other serious inflammatory diseases.”
The trial has been designed to assess filgotinib on a background of conventional synthetic disease-modifying anti-rheumatic drug(s) (csDMARDs) among adult patients with moderately-to-severely active rheumatoid arthritis who had not adequately responded to biologic DMARDs (bDMARDs).
In the Finch 2 study, the 23.7% of patients had secured three or more bDMARDs, and patients have been randomized 1:1:1 to receive filgotinib 100mg, filgotinib 200mg or placebo.
Galapagos collaborated with Gilead for the development and commercialization of filgotinib in inflammatory indications.
The phase 3 Finch 2 trial is one of several clinical studies of filgotinib in rheumatoid arthritis or other inflammatory diseases.
Other studies include Finch 1 and Finch 2, Equator phase 2 program in psoriatic arthritis, Tortuga study in ankylosing spondylitis, Diversity phase 3 trial in Crohn’s disease and Selection phase 3 trial in ulcerative colitis.
Galapagos chief medical officer Walid Abi-Saab said: “We are pleased that filgotinib has demonstrated significantly improved clinical responses in this difficult to treat population.”