Mechelen, Belgium; 28 February 2014 - Galapagos NV (Euronext: GLPG) announced today that GSK has updated the development status for GSK2586184, involving three clinical studies in psoriasis, lupus, and ulcerative colitis.
GSK2586184 is a selective JAK1 inhibitor which was discovered and developed within Galapagos' inflammation alliance with GSK. GSK in-licensed the molecule in February 2012, gaining worldwide rights to further development and commercialization. Galapagos is eligible, without further financial investment from Galapagos, to receive from GSK up to €34M in additional milestones, plus up to double-digit royalties on global commercial sales of all therapeutic indications of GSK2586184.
All dosing of patients in the Phase 2 study in psoriasis has completed. Topline efficacy and safety results from this study are expected in the first half of 2014. Galapagos is eligible to receive a milestone payment from GSK in the event that GSK achieves a successful Proof-of-Concept in patients treated with GSK2586184. The psoriasis study was designed to recruit 64 patients, with treatment up to 12 weeks.
The Phase 2 study in systemic lupus erythematosis has been stopped at the planned first interim analysis by GSK due to a lack of effect. GSK notified Galapagos that the pre-defined stopping criteria were clearly met, triggering GSK to discontinue the lupus study with GSK2586184.
GSK has put the exploratory Phase 1/2 study in ulcerative colitis on hold. This study is designed to recruit up to 15 ulcerative colitis patients on treatment with GSK2586184.
Further details of the GSK studies with GSK2586184 can be found at www.clinicaltrials.gov.
Galapagos (Euronext: GLPG; OTC: GLPYY) is specialized in novel modes-of-action, with a large pipeline comprising of six Phase 2 studies (three led by GSK), one Phase 1 study, six 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 a worldwide license agreement whereby AbbVie will be responsible for further development and commercialization of GLPG0634 after Phase 2B. 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 out-licensed the selective JAK1 inhibitor GSK2586184, (formerly GLPG0778) to GlaxoSmithKline in 2012. It is currently in Phase 2 for psoriasis and ulcerative colitis. GLPG0974 is the first inhibitor of FFA2 to be evaluated clinically for the treatment of IBD; this program is currently in a Proof-of-Concept Phase 2 study. GLPG1205 is a first-in-class molecule that targets inflammatory disorders and has completed Phase 1. AbbVie and Galapagos signed an agreement in CF where they work collaboratively to develop and commercialize oral drugs that address two mutations in the CFTR gene, the G551D and F508del mutation. Potentiator GLPG1837 is at the pre-clinical candidate stage. The Galapagos Group, including fee-for-service companies BioFocus, Argenta and Fidelta, has around 800 employees and operates facilities in five countries, with global headquarters in Mechelen, Belgium. Further information at: www.glpg.com
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