Galapagos (GLPG.BR) Release: Phase 3 Study With Filgotinib Initiated In Crohn's Disease
11/23/2016 1:49:44 PM
First patient dosed triggers $50 million milestone payment
Mechelen, Belgium; 22 November 2016 - Galapagos NV (Euronext & NASDAQ: GLPG) reports the first dosing of a patient in the DIVERSITY Phase 3 study with filgotinib in Crohn's disease (CD). The start of the DIVERSITY study triggers a $50 million milestone payment from Gilead.
The worldwide DIVERSITY Phase 3 study will investigate efficacy and safety of 100 mg and 200 mg filgotinib once-daily compared to placebo in 1,320 patients with moderately to severely active Crohn's disease, including those with prior biological therapy failure.
"With the FITZROY Phase 2 study, Galapagos demonstrated that filgotinib has a promising efficacy and safety profile in Crohn's disease. The start of the Phase 3 DIVERSITY study is good news for patients with Crohn's disease," said Dr Piet Wigerinck, CSO of Galapagos. "We look forward to seeing the results of DIVERSITY."
Galapagos and Gilead entered into a global collaboration for the development and commercialization of filgotinib in inflammatory indications. In addition to the DIVERSITY study, Gilead initiated the FINCH Phase 3 program in rheumatoid arthritis in August 2016 and is expected to start the SELECTION Phase 2b/3 study in ulcerative colitis later this quarter.
Filgotinib is an investigational drug and its efficacy and safety have not been established.
For information about the studies with filgotinib in IBD: www.clinicaltrials.gov
For more information about filgotinib: www.glpg.com/filgotinib
Galapagos (Euronext & NASDAQ: GLPG) 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, pre-clinical, 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 480 employees, operating from its Mechelen, Belgium headquarters and facilities in The Netherlands, France, and Croatia. More information at www.glpg.com.
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