2 April 2019 - - US-based biopharmaceutical company Gilead Sciences, Inc. (NASDAQ: GILD) and Belgium-based Galapagos NV (NASDAQ: GLPG) have received favourable Week 24 results of FINCH 3, an ongoing, randomised, double-blind, active-controlled Phase 3 study of filgotinib, an investigational, oral, selective JAK1 inhibitor, in adults with moderately-to-severely active rheumatoid arthritis, the companies said.

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.

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.

The safety profile of filgotinib in FINCH 3 is consistent with prior studies up to Week 24, the companies said.

Detailed findings from FINCH 3 will be submitted for presentation at a future scientific conference. Filgotinib is an investigational agent and not approved anywhere globally.

Its efficacy and safety have not been established.

FINCH 3 is an ongoing 52-week randomized, double-blind and active-controlled study examining filgotinib alone and in combination with MTX, enrolling 1,252 adult patients with moderately to severely active RA who are naïve to MTX.

Patients were randomised (2: 1: 1:2) to receive filgotinib 200 mg plus MTX (n=417), filgotinib 100 mg plus MTX (n=207), filgotinib 200 mg alone (n=210) or MTX (n=418). The primary endpoint is the proportion of patients who achieve an ACR20 response at Week 24.

Galapagos and Gilead entered into a global collaboration for the development and commercialization of filgotinib in inflammatory indications.

The FINCH studies are among several clinical trials of filgotinib in inflammatory diseases, including the EQUATOR Phase 2 programme in psoriatic arthritis, the TORTUGA study in ankylosing spondylitis, the DIVERSITY Phase 3 trial in Crohn's disease (also small bowel and fistulizing Crohn's disease Phase 2 studies) and the Phase 3 SELECTION trial in ulcerative colitis.

Galapagos discovers and develops small molecule medicines with novel modes of action, three of which show promising patient results and are currently in late-stage development in multiple diseases.