Filgotinib meets primary endpoint in the Phase III RA study

Belgium-based biotech firm Galapagos (Euronext: GLPG) is celebrating its 20-year anniversary with positive Phase III data on lead product candidate filgotinib, with the news sending its share rocketing more than 15% to 97.84 euros by early afternoon trading.

Discovered by Galapagos and developed with partner Gilead Sciences (Nasdaq: GILD), the drug moves one step closer to bringing its first medicine, a potential new treatment for rheumatoid arthritis, to the market. Gilead’s shares edged up 1.9% to $64.90 in pre-market trading today.

Week 24 results of FINCH 3, an ongoing, randomized, double-blind, active-controlled Phase III study of filgotinib, an investigational, oral, selective JAK1 inhibitor, in adults with moderately-to-severely active rheumatoid arthritis. FINCH 3 evaluated filgotinib in combination with methotrexate and as monotherapy in MTX-naïve patients. The study achieved its primary endpoint in the proportion of patients achieving an American College of Rheumatology 20% response (ACR20) at Week 24. The proportion of patients achieving the primary endpoint of ACR20 response at Week 24 was significantly higher for filgotinib 200 mg plus MTX and filgotinib 100 mg plus MTX compared with MTX alone.