GILEAD AND GALAPAGOS ANNOUNCE FILGOTINIB MEETS PRIMARY ENDPOINT IN THE PHASE 3 FINCH 3 STUDY IN METHOTREXATE-NAÏVE RHEUMATOID ARTHRITIS PATIENTS

-- Filgotinib 100 mg and 200 mg Plus Methotrexate (MTX) Demonstrated Significantly Higher ACR20/50/70 Responses Than Methotrexate Alone --

-- Filgotinib Safety Profile Consistent With Previously Reported Results --

 

Foster City, Calif. and Mechelen, Belgium; March 28, 2019; 22.01 CET; regulated information - Gilead Sciences, Inc. (NASDAQ: GILD) and Galapagos NV (Euronext & NASDAQ: GLPG) today announced Week 24 results of FINCH 3, an ongoing, randomized, double-blind, active-controlled Phase 3 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 percent 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. 

The proportion of patients achieving ACR50, ACR70, and clinical remission (DAS28(CRP) < 2.6) at Week 24 was also significantly higher for patients receiving once-daily filgotinib 100 mg or 200 mg plus MTX compared with patients receiving MTX alone. Additionally, those who received filgotinib experienced greater reduction in the Health Assessment Questionnaire Disability Index (HAQ-DI) compared with those receiving MTX alone at Week 24. Filgotinib 200 mg monotherapy inhibited the progression of structural damage at Week 24 compared with MTX alone as assessed by modified total Sharp score (mTSS).

Top-line FINCH 3 efficacy^{^} data are summarized in the table below: 

 

	Filgotinib 200 mg + MTX (n=416) &	Filgotinib 100 mg + MTX (n=207) &	Filgotinib 200 mg monotherapy (n=210) &	MTX (n=416) &
ACR20 (%)	81.0***	80.2*	78.1	71.4
ACR50 (%)	61.5***	57.0**	58.1**#	45.7
ACR70 (%)	43.8***	40.1***	40.0***#	26.0
DAS28(CRP) < 2.6 (Clinical remission) (%)	54.1***	42.5***	42.4***#	29.1
HAQ-DI change	-0.94***	-0.90**	-0.89*#	-0.79
mTSS change	0.20	0.22	-0.04**#	0.52

^{^}Efficacy assessed at Week 24 for all endpoints