Galapagos Release: FITZROY Phase 2 Study With Filgotinib In Crohn's Disease Presented As Late Breaker At DDW 2016
Mechelen, Belgium; 25 May 2016, 22.00 CET: Galapagos (Euronext & NASDAQ: GLPG) announces the presentation of detailed results from the Phase 2 FITZROY study of filgotinib in Crohn's Disease, at Digestive Disease Week (DDW[1]) 2016 in San Diego, CA, USA, held from 21-24 May. More information can be found at www.ddw.org.
Prof. Dr. Séverine Vermeire, the principal investigator of the FITZROY study, presented the results from this 174-patient study, initially reported in December 2015. Galapagos reported 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.
The oral presentation, "Filgotinib (GLPG0634), an oral JAK1 selective inhibitor, induces clinical remission in patients with moderate-to-severe Crohn's disease: results from the Phase 2 FITZROY study interim analysis," took place today, during the Clinical science late-breaking abstracts plenary session, abstract #2488299.
In this Phase 2 study, filgotinib also demonstrated improvement in quality of life (IBDQ). The rate of treatment-emergent adverse events was similar between the filgotinib and placebo arms. The results support further development of filgotinib in inflammatory bowel disease (IBD).
The company also presented a poster entitled "The JAK1-selective inhibitor, filgotinib, reverses the disease signature of colon mucosa in experimental colitis." The authors reported filgotinib prevents the changes observed in mucosal gene expression induced by colitis, and that several of these genes also display changes in human IBD. This poster was presented in the session "Cytokines, Signaling and Receptors" on 21 May, abstract #2442351, poster # Sa1844.
As per DDW policy, Galapagos is prohibited from distributing the presentation and poster. Please contact the DDW organization (www.ddw.org) to receive a copy. Galapagos did not provide financial support for the above scientific sessions and did not influence the content in any way. However, research presented within these scientific sessions were supported by Galapagos.
Galapagos and Gilead entered into a global collaboration agreement for the global development and commercialization of filgotinib in inflammatory diseases. The agreement became effective on January 19, 2016. 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 and a Phase 2 trial in ulcerative colitis.
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 maturing pipeline comprises Phase 2, Phase 1, pre-clinical and 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.
Prof. Dr. Séverine Vermeire, the principal investigator of the FITZROY study, presented the results from this 174-patient study, initially reported in December 2015. Galapagos reported 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.
The oral presentation, "Filgotinib (GLPG0634), an oral JAK1 selective inhibitor, induces clinical remission in patients with moderate-to-severe Crohn's disease: results from the Phase 2 FITZROY study interim analysis," took place today, during the Clinical science late-breaking abstracts plenary session, abstract #2488299.
In this Phase 2 study, filgotinib also demonstrated improvement in quality of life (IBDQ). The rate of treatment-emergent adverse events was similar between the filgotinib and placebo arms. The results support further development of filgotinib in inflammatory bowel disease (IBD).
The company also presented a poster entitled "The JAK1-selective inhibitor, filgotinib, reverses the disease signature of colon mucosa in experimental colitis." The authors reported filgotinib prevents the changes observed in mucosal gene expression induced by colitis, and that several of these genes also display changes in human IBD. This poster was presented in the session "Cytokines, Signaling and Receptors" on 21 May, abstract #2442351, poster # Sa1844.
As per DDW policy, Galapagos is prohibited from distributing the presentation and poster. Please contact the DDW organization (www.ddw.org) to receive a copy. Galapagos did not provide financial support for the above scientific sessions and did not influence the content in any way. However, research presented within these scientific sessions were supported by Galapagos.
Galapagos and Gilead entered into a global collaboration agreement for the global development and commercialization of filgotinib in inflammatory diseases. The agreement became effective on January 19, 2016. 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 and a Phase 2 trial in ulcerative colitis.
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 maturing pipeline comprises Phase 2, Phase 1, pre-clinical and 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.