Program to enter first Phase 2 patient study in ulcerative colitis this month
MECHELEN, Belgium, Dec. 16, 2014 (GLOBE NEWSWIRE) -- Galapagos NV (Euronext: GLPG) announced today it has agreed with Janssen Pharmaceutica NV that Galapagos will regain full and unencumbered rights to the entire GPR84 program going forward, which includes the inhibitor GLPG1205 and its backup compound GLPG2196. No further details were disclosed.
GLPG1205 ('1205), works on GPR84, a novel mechanism of action developed by Galapagos for Inflammatory Bowel Diseases (IBD). Earlier this year, Galapagos presented compelling pre-clinical evidence for GPR84 playing a key role in IBD pathology. The discovery of a selective antagonist of GPR84 led to GLPG1205, which shows strong efficacy in relevant pre-clinical models for IBD. Galapagos disclosed last year that '1205 showed good safety, target engagement, and favorable drug-like properties in Phase 1 studies in healthy volunteers. Galapagos plans to initiate Phase 2 trial patient recruitment before year end 2014.
G-coupled protein receptor 84 (GPR84) is a free fatty acid protein involved in the regulation of macrophages, monocytes, and neutrophils in the human immune system. Galapagos identified GPR84 as playing a key role in inflammation, using its proprietary target discovery platform. GPR84 is over-expressed in inflammatory disease patients. Galapagos has confirmed using in vitro models that GPR84 inhibition prevents neutrophil and macrophage chemotaxis induced by specific triggers, and in relevant in vivo models that '1205 prevents IBD disease progression. Novel medicine '1205 is also the first selective inhibitor of GPR84 to be tested in humans, showing good safety, inhibition of GPR84, and favorable drug-like properties in Phase 1 studies.
Galapagos (Euronext: GLPG; OTC: GLPYY) is specialized in novel modes-of-action, with a large pipeline comprising three Phase 2 studies, two Phase 1 studies, five pre-clinical, and 20 discovery small-molecule and antibody programs in cystic fibrosis, inflammation, antibiotics, metabolic disease, and other indications. In the field of inflammation, AbbVie and Galapagos signed an agreement for the development and commercialization of GLPG0634. GLPG0634 is an orally-available, selective inhibitor of JAK1 for the treatment of rheumatoid arthritis and potentially other inflammatory diseases, currently in Phase 2B studies in RA and in Phase 2 in Crohn's disease. Galapagos has another selective JAK1 inhibitor, GSK2586184 (formerly GLPG0778, in-licensed by GlaxoSmithKline in 2012). GLPG0974 is the first inhibitor of FFA2 to be evaluated clinically for the treatment of IBD; this program has completed a Proof-of-Concept Phase 2 study. GLPG1205 is a first-in-class molecule that targets inflammatory disorders and has completed Phase 1. GLPG1690 is a first-in-class compound that targets pulmonary diseases and is currently in a Phase 1 study. AbbVie and Galapagos signed an agreement in cystic fibrosis to develop and commercialize molecules that address mutations in the CFTR gene. Potentiator GLPG1837 is expected to start Phase 1 this month. The first Galapagos corrector GLPG2222 is at the pre-clinical candidate stage. The Galapagos Group, including fee-for-service subsidiary Fidelta, has around 400 employees, operating from its Mechelen, Belgium headquarters and facilities in The Netherlands, France, and Croatia. Further information at: www.glpg.com
Elizabeth Goodwin, Head of Corporate Communications & IR
Tel: +31 6 2291 6240
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