Galapagos NV Announces New Phase 2 Study

“We are pleased with the initiation of this new Phase 2 study with filgotinib,” said Dr. Walid Abi-Saab, Chief Medical Officer of Galapagos. “We look forward to seeing the study results which will show whether filgotinib has the potential to impact signs and symptoms of non-infectious uveitis, a group of inflammatory diseases carrying significant visual morbidities.”

The Phase 2 study will be a multi-center, randomized, double-masked, placebo-controlled study to assess the safety and efficacy of filgotinib in adult patients with active, non-infectious uveitis. Approximately 110 patients are planned to be randomized in the study to receive filgotinib or placebo administered for 52 weeks. The primary goal is to evaluate the efficacy and safety of filgotinib versus placebo for the treatment of non-infectious intermediate-, posterior- or pan-uveitis. The primary outcome is measured by the proportion of subjects failing treatment by week 24; treatment failure is representative of an active uveitis flare.

Galapagos and Gilead entered into a global collaboration for the development and commercialization of filgotinib in inflammatory indications. This study is an addition to the ongoing Phase 2 studies in cutaneous lupus erythematosus, Sjögren’s syndrome, ankylosing spondylitis and psoriatic arthritis, as well as the ongoing Phase 3 program in rheumatoid arthritis, the Phase 3 study in Crohn’s disease (also Phase 2 in small bowel and fistulizing Crohn’s disease), and Phase 2b/3 study in ulcerative colitis. Filgotinib is an investigational drug and its efficacy and safety have not been established. For information about the studies with filgotinib: www.clinicaltrials.gov. For more information about filgotinib: www.glpg.com/filgotinib

Galapagos is a clinical-stage biotechnology company specialized in the discovery and development of small molecule medicines with novel modes of action. Our pipeline comprises a pipeline of Phase 3, Phase 2, Phase 1, preclinical, and discovery programs in cystic fibrosis, inflammation, fibrosis, osteoarthritis, and other indications. We have discovered and developed filgotinib: in collaboration with Gilead, we aim to bring this JAK1-selective inhibitor for inflammatory indications to patients all over the world. 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 530 employees, operating from its Mechelen, Belgium, headquarters and facilities in The Netherlands, France, and Croatia. For more information, visit www.glpg.com.