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GILEAD AND GALAPAGOS TO PRESENT LATEST DATA ON FILGOTINIB AT THE ANNUAL EUROPEAN CONGRESS OF RHEUMATOLOGY (EULAR 2019)

Nachrichtenquelle: GlobeNewswire
29.05.2019, 22:30  |  462   |   |   

-- Phase 3 FINCH 1 and FINCH 3 Data of Filgotinib in Rheumatoid Arthritis to Be Featured in Opening Plenary and Late Breaker Sessions --

Foster City, Calif. and Mechelen, Belgium; May 29, 2019; 22.30 CET - Gilead Sciences, Inc. (NASDAQ: GILD) and Galapagos NV (Euronext & NASDAQ: GLPG) today announced that data on filgotinib, an investigational, oral, selective JAK1 inhibitor, will be presented at the Annual European Congress of Rheumatology (EULAR 2019) in Madrid, Spain, on June 12-15, 2019. Among the abstracts to be presented are 24 week interim results from the ongoing FINCH 1 and FINCH 3 Phase 3 studies evaluating filgotinib in adults with rheumatoid arthritis.

"These data reinforce our belief that filgotinib has the potential to make a meaningful difference for patients with rheumatoid arthritis, both early and also late in the course of treatment when other treatments have failed," said John McHutchison, AO, MD, Chief Scientific Officer, Head of Research and Development, Gilead Sciences. "The FINCH results reflect the growing strength and breadth of Gilead's inflammation pipeline and our commitment to improving the outlook for patients living with inflammatory diseases - both with filgotinib and our other investigational compounds."

"This meeting marks our first opportunity to present the results from the FINCH 1 and 3 filgotinib trials in rheumatoid arthritis," said Dr. Walid Abi-Saab, Chief Medical Officer, Galapagos. "These results show the potential of filgotinib in helping to address the unmet need for people living with this debilitating disease."

Phase 3 Trials of Filgotinib in Rheumatoid Arthritis

Detailed 24 week interim results from the Phase 3 FINCH 1 and 3 clinical trials will both be presented for the first time in oral sessions at the conference.  Top-line data from these studies were announced earlier this year. Findings from FINCH 1 will be presented in the opening plenary session, while FINCH 3 results will be presented in the late-breaking abstract session.

  • Efficacy and Safety of Filgotinib for Patients with Rheumatoid Arthritis with Inadequate Response to Methotrexate: FINCH1 Primary Outcome Results (oral #LB0001 4:25pm CET, 12 June, Hall 6)
  • Efficacy and Safety of Filgotinib for Patients with Rheumatoid Arthritis Naïve to Methotrexate Therapy: FINCH3 Primary Outcome Results (oral #LB0003 8:00am CET, 15 June, Hall 7B)

FINCH 1 is an ongoing, randomized, double-blind, placebo- and active-controlled Phase 3 study evaluating filgotinib versus adalimumab or placebo in adults with moderately-to-severely active rheumatoid arthritis on a stable background dose of methotrexate but with a prior inadequate response to methotrexate. The study achieved its primary endpoint at both 100 mg and 200 mg doses of filgotinib, in the proportion of patients achieving an American College of Rheumatology (ACR) 20 percent response (ACR20) compared with placebo at Week 12.

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