MECHELEN, Belgium I March 18, 2016 I Galapagos (Euronext & NASDAQ: GLPG) announces the presentation of detailed results from the Phase 2 FITZROY study of filgotinib in Crohn’s Disease, at the 11th Congress of ECCO in Amsterdam, the Netherlands, from March 16 – 19.
Prof Dr Severine Vermeire, the principal investigator of the FITZROY study, will be presenting the results on the 10-week on treatment analysis. These results from this 174-patient study were reported in December 2015 and indicated that the study achieved the primary endpoint of clinical remission: the percentage of patients achieving a Crohn’s Disease Activity Index (CDAI) score lower than 150 was statistically significantly higher in patients treated with filgotinib versus patients receiving placebo (48 percent (61/128) vs. 23 percent (10/44), p<0.05).
The presentation on 18 March, takes place at the Scientific Session in ECCO Fellowship & Grants, at 15.50 – 16.00 hours CET. Filgotinib is the first JAK inhibitor to show clinical efficacy in moderate to severely active Crohn’s Disease. Furthermore, filgotinib showed improvement in quality of life (IBDQ) in TNF-naive and TNF-failure populations. The rate of treatment-emergent adverse events was similar between the filgotinib and placebo arms; the most common adverse events occurring in each study arm were infections and infestations (26 percent vs. 23 percent), gastrointestinal disorders (24 percent vs. 23 percent) and nervous system disorders (16 percent vs. 18 percent). The 10-week results support further development of filgotinib in inflammatory bowel disease (IBD). Galapagos and Gilead Sciences also expect to report the full 20-week results for FITZROY in the first half of 2016.
In December 2015, Galapagos and Gilead signed a global collaboration agreement for the global development and commercialization of filgotinib in inflammatory diseases. Under the terms of the agreement, the companies will collaborate jointly on the global development of filgotinib starting with the initiation of Phase 3 trials in rheumatoid arthritis and Crohn’s Disease.
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 three Phase 2, three Phase 1, five pre-clinical, and 20 discovery studies 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 440 employees, operating from its Mechelen, Belgium headquarters and facilities in The Netherlands, France, and Croatia. More information at www.glpg.com.
SOURCE: Galapagos
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MECHELEN, Belgium I March 18, 2016 I Galapagos (Euronext & NASDAQ: GLPG) announces the presentation of detailed results from the Phase 2 FITZROY study of filgotinib in Crohn’s Disease, at the 11th Congress of ECCO in Amsterdam, the Netherlands, from March 16 – 19.
Prof Dr Severine Vermeire, the principal investigator of the FITZROY study, will be presenting the results on the 10-week on treatment analysis. These results from this 174-patient study were reported in December 2015 and indicated that the study achieved the primary endpoint of clinical remission: the percentage of patients achieving a Crohn’s Disease Activity Index (CDAI) score lower than 150 was statistically significantly higher in patients treated with filgotinib versus patients receiving placebo (48 percent (61/128) vs. 23 percent (10/44), p<0.05).
The presentation on 18 March, takes place at the Scientific Session in ECCO Fellowship & Grants, at 15.50 – 16.00 hours CET. Filgotinib is the first JAK inhibitor to show clinical efficacy in moderate to severely active Crohn’s Disease. Furthermore, filgotinib showed improvement in quality of life (IBDQ) in TNF-naive and TNF-failure populations. The rate of treatment-emergent adverse events was similar between the filgotinib and placebo arms; the most common adverse events occurring in each study arm were infections and infestations (26 percent vs. 23 percent), gastrointestinal disorders (24 percent vs. 23 percent) and nervous system disorders (16 percent vs. 18 percent). The 10-week results support further development of filgotinib in inflammatory bowel disease (IBD). Galapagos and Gilead Sciences also expect to report the full 20-week results for FITZROY in the first half of 2016.
In December 2015, Galapagos and Gilead signed a global collaboration agreement for the global development and commercialization of filgotinib in inflammatory diseases. Under the terms of the agreement, the companies will collaborate jointly on the global development of filgotinib starting with the initiation of Phase 3 trials in rheumatoid arthritis and Crohn’s Disease.
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 three Phase 2, three Phase 1, five pre-clinical, and 20 discovery studies 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 440 employees, operating from its Mechelen, Belgium headquarters and facilities in The Netherlands, France, and Croatia. More information at www.glpg.com.
SOURCE: Galapagos
Post Views: 35
