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FITZROY Phase 2 study with filgotinib in Crohn's Disease presented as late breaker at DDW 2016 | ||||||||||||
By: Nasdaq / GlobeNewswire - 25 May 2016 | Back to overview list |
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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.
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[1] The name, logo and acronym of Digestive Disease Week ® are the exclusive property of and are trademarked by DDW LLC.
This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein. Source: Galapagos NV via GlobeNewswire
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