Galapagos Release: Start Phase 2b/3 Study With Filgotinib In Ulcerative Colitis
First patient dosed triggers a $10 million milestone payment
Mechelen, Belgium; 8 December 2016 - Galapagos NV (Euronext & NASDAQ: GLPG) reports the first dosing of a patient in the SELECTION Phase 2b/3 study with filgotinib in ulcerative colitis. The start of the SELECTION study triggers a $10 million milestone payment from Gilead.
The worldwide SELECTION Phase 2b/3 study will investigate efficacy and safety of 100 mg and 200 mg filgotinib once-daily compared to placebo in 1,300 patients with moderately to severely active disease, including those with prior biological therapy failure. The DIVERSITY Phase 3 study in Crohn's disease with filgotinib started in November.
"Our collaboration partner Gilead is definitely keeping up the speed in rolling out studies with filgotinib," said Piet Wigerinck, CSO of Galapagos. "We look forward to seeing the results of both the DIVERSITY and SELECTION studies in inflammatory bowel disease."
Galapagos and Gilead entered into a global collaboration for the development and commercialization of filgotinib in inflammatory indications. In addition to the DIVERSITY and SELECTION studies, Gilead initiated the FINCH Phase 3 program in rheumatoid arthritis in August 2016.
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
About Galapagos
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.
Mechelen, Belgium; 8 December 2016 - Galapagos NV (Euronext & NASDAQ: GLPG) reports the first dosing of a patient in the SELECTION Phase 2b/3 study with filgotinib in ulcerative colitis. The start of the SELECTION study triggers a $10 million milestone payment from Gilead.
The worldwide SELECTION Phase 2b/3 study will investigate efficacy and safety of 100 mg and 200 mg filgotinib once-daily compared to placebo in 1,300 patients with moderately to severely active disease, including those with prior biological therapy failure. The DIVERSITY Phase 3 study in Crohn's disease with filgotinib started in November.
"Our collaboration partner Gilead is definitely keeping up the speed in rolling out studies with filgotinib," said Piet Wigerinck, CSO of Galapagos. "We look forward to seeing the results of both the DIVERSITY and SELECTION studies in inflammatory bowel disease."
Galapagos and Gilead entered into a global collaboration for the development and commercialization of filgotinib in inflammatory indications. In addition to the DIVERSITY and SELECTION studies, Gilead initiated the FINCH Phase 3 program in rheumatoid arthritis in August 2016.
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
About Galapagos
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.