ABOUT US R&D FIDELTA INVESTORS NEWS & EVENTS CAREERS CONTACT Clinical Pipeline Filgotinib – RA/Crohn's GLPG1837 – CF GLPG1205 – Ulcerative colitis GLPG1690 – IPF MOR106 – Inflammatory diseases GLPG0778/555 – Immun/inflam Alliances Business Development Target & Discovery Approach Clinical Trials GLPG1205 GLPG1205 targets GPR84, a novel target for inflammatory disorders that was identified and validated by Galapagos using its proprietary target discovery engine. Subsequent Galapagos research led to the discovery of GLPG1205, a first-in-class molecule for inflammatory disorders like inflammatory bowel disease. GLPG1205 is fully proprietary to Galapagos. Galapagos announced that GLPG1205 has demonstrated target engagement, a good safety profile, and favorable drug properties in a Phase 1 study. The aim of this study was to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of oral single and multiple ascending doses of GLPG1205. The randomized, double-blind, placebo-controlled, single center study was conducted in 40 healthy volunteers in Belgium. In the first part of the study, single ascending doses were evaluated. In the second part, the new compound was administered daily for 14 days. The data shown in Phase 1 encouraged Galapagos to progress GLPG1205 into a Phase 2A study in Inflammatory Bowel Disease (IBD). Galapagos is currently testing GLPG1205 in a Phase 2 Proof-of-Concept study in ulcerative colitis patients. The aim of this study is to evaluate the efficacy, safety and tolerability and pharmacokinetics of ‘1205, and to explore the effects of ‘1205 on selected biomarkers in this patient population. Recruitment for this study is completed. Patients received either 100 mg of ‘1205 or placebo (2:1 ratio) once-daily, for a period of twelve weeks. The primary endpoint will be the change in Mayo scores versus baseline at 8 weeks, which includes endoscopic confirmation on improvement of ulceration. This randomized, double-blind study recruited patients in multiple sites in 6 countries: Belgium, Hungary, Poland, Czech Republic, Germany and Russia. The trial is anticipated to deliver top line data in Q1 2016. Related publications Human safety, pharmacokinetics and pharmacodynamics of the GPR84 antagonist GLPG1205, a potential new approach to treat IBD F. Vanhoutte, S. Dupont, T. Van Kaem, M-H. Gouy, R. Blanqué, R. Brys, N. Vandeghinste, L. Gheyle, W. Haazen, G. van ‘t Klooster, J. Beetens ECCO2015 Human safety, pharmacokinetics and pharmacodynamics of the GPR84 antagonist GLPG1205, a potential new approach to treat IBD F. Vanhoutte, S. Dupont, T. Van Kaem, M-H. Gouy, L. Gheyle, R. Blanqué, R. Brys, N. Vandeghinste, W. Haazen, G. van 't Klooster, J.Beetens UEGW2014 GPR84, a novel target for the development of therapies for IBD Sonia Dupont, Frédéric Labéguère, Roland Blanqué, Steve de Vos, Philippe Clément-Lacroix, Isabelle Parent, Corinne Saccomani, Luc Nellen, Annick Hagers, Céline Cottereaux, Didier Merciris, Marie-Christine Ceccotti, Cécile Belleville Da Costa, Stephen Fletcher, Reginald Brys UEGW2014 GLPG1690 GLPG1690 is a selective autotaxin inhibitor discovered by Galapagos, with potential application in idiopathic pulmonary disease (IPF). In a Phase 1 study in healthy human volunteers, GLPG1690 demonstrated favorable safety and tolerability, as well as a strong pharmacodynamic signal implying target engagement. Galapagos is currently preparing a Phase 2 study in IPF, to be filed for approval before the end of 2015. GLPG1690 is fully proprietary to Galapagos. Top © Copyright 2015 Galapagos NV | Disclaimer | General Purchase Terms Test