Therapy Areas: Hereditary Disorders
Filgotinib Meets Primary and All Key Secondary Endpoints in First Phase 3 Study in Rheumatoid Arthritis, According to Gilead and Galapagos
12 September 2018 - - FINCH 2, a global, randomised, placebo-controlled, Phase 3 study of filgotinib, an investigational, selective JAK1 inhibitor, in adults with moderately-to-severely active rheumatoid arthritis and prior inadequate response/intolerance to biologic agents, achieved its primary endpoint in the proportion of patients achieving an American College of Rheumatology 20% response (ACR20) at Week 12, US-based biopharmaceutical company Gilead Sciences, Inc. (NASDAQ: GILD) and Belgium-based biotechnology company Galapagos NV (Euronext and NASDAQ: GLPG) said.

Also at Weeks 12 and 24, the proportion of patients achieving ACR50 and ACR70, low disease activity (LDA, DAS28(CRP) ≤ 3.2), and clinical remission (DAS28(CRP) < 2.6) were significantly higher for patients receiving once-daily filgotinib 100 mg or 200 mg compared to patients receiving placebo.

Filgotinib was generally well-tolerated in the FINCH 2 trial, with no new safety signals compared to those reported in previous trials of filgotinib.

Treatment-emergent adverse events and serious adverse events were mostly mild or moderate in severity. Serious adverse events occurred in 3.4, 5.2 and 4.1% of the patients in the placebo, 100mg and 200mg groups, respectively.

The proportion of patients who discontinued study drug due to treatment-emergent adverse events was also similar across groups.

Two cases of uncomplicated herpes zoster were reported in each filgotinib group. Two major adverse cardiovascular events were identified, one subarachnoid hemorrhage in the placebo group and one myocardial ischemia in the filgotinib 100 mg group.

There was one case of non-serious retinal vein occlusion in the filgotinib 200 mg group and no reports of deep venous thrombosis or pulmonary embolism. There were no deaths, malignancies, gastrointestinal perforations, or opportunistic infections, including active tuberculosis.

Detailed findings from the FINCH 2 study will be submitted for presentation at a future scientific conference.

Filgotinib is investigational and not approved anywhere globally. Its efficacy and safety have not been established.

FINCH 2 was a global, 24-week randomised, double-blind, placebo-controlled, Phase 3 study evaluating 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 this study, 23.7% of patients had received three or more bDMARDs.

Patients were randomized (1: 1: 1) to receive filgotinib 100 mg, filgotinib 200 mg or placebo. The primary endpoint was the proportion of patients achieving an ACR20 response at week 12.

Protocol-defined non-responders at Week 14 were allowed to complete the trial under standard of care therapy. Treatment-emergent adverse events are those reported during treatment or within 30 days of the last dose of study drug.

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

Along with FINCH 1 and 3, the Phase 3 FINCH 2 trial is one of several clinical trials of filgotinib in rheumatoid arthritis or other inflammatory diseases, including the EQUATOR Phase 2 program 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 (Euronext and NASDAQ: GLPG) is a clinical-stage biotechnology company specialised in the discovery and development of small molecule medicines with novel modes of action. Galapagos' pipeline comprises Phase 3 through to discovery programs in cystic fibrosis, inflammation, fibrosis, osteoarthritis and other indications.

The company's target discovery platform has delivered three novel mechanisms showing promising patient results in, respectively, inflammatory diseases, idiopathic pulmonary fibrosis and atopic dermatitis.

Galapagos is focused on the development and commercialization of novel medicines that will improve people's lives.

The Galapagos group, including fee-for-service subsidiary Fidelta, has approximately 675 employees, operating from its Mechelen, Belgium headquarters and facilities in the Netherlands, France, Switzerland, the US and Croatia.

Gilead Sciences is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need.

The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.
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