MECHELEN, Belgium, Nov. 12, 2014 (GLOBE NEWSWIRE) -- Galapagos NV (Euronext: GLPG), a clinical stage biotech company focused on developing novel mode of action medicines, announces that recruitment of rheumatoid arthritis (RA) patients for the Darwin 1 Phase 2B study with GLPG0634 has been completed.
Selective JAK1 inhibitor GLPG0634 (filgotinib) has shown a best-in-class profile in two 4-week Phase 2A studies in RA patients. GLPG0634 is currently in a global Phase 2B program (DARWIN) in 875 RA patients and in a Phase 2 study in 180 patients with Crohn's disease.
DARWIN 1 plans to enroll 595 patients with moderate to severe rheumatoid arthritis who insufficiently respond to methotrexate but remain on their background therapy of methotrexate. DARWIN 1 is a double-blind, placebo-controlled evaluation of three doses of GLPG0634, as once- and twice-daily administration. Following the closure of recruitment, the last patient will now be randomized in the study before the end of the month. Topline, blinded results from the first 12 weeks of treatment in DARWIN 1 are expected around the end of Q1 2015, with topline 24 weeks results expected three months later.
DARWIN 2 plans to enroll 280 patients with moderate to severe rheumatoid arthritis who insufficiently respond to methotrexate. DARWIN 2 is a double-blind, placebo-controlled investigation of three once-daily dose levels of GLPG0634 as monotherapy treatment. Completion of recruitment for DARWIN 2 is expected in the coming weeks. Topline results from 12 week results are expected in Q2 2015, with complete 24 week data package expected in Q3 2015. AbbVie will base its licensing decision on the complete 24 week DARWIN 1 and 2 data packages from GLPG0634.
Dr Piet Wigerinck, Chief Scientific Officer of Galapagos, commented: "We are pleased that recruitment for Darwin 1 has been completed and that Darwin 2 is on track to complete recruitment in the coming weeks. We see a good spread of patients coming in across the major geographic areas and continue to see more than 90% of patients who complete the DARWIN 1 and 2 studies enroll in the DARWIN 3 long-term extension study. We are encouraged by this roll-over rate, and we look forward to seeing all the results next year."
Galapagos (Euronext: GLPG; OTC: GLPYY) is specialized in novel modes-of-action, with a 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 and metabolic disease. 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 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). 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 in 2014. Galapagos also expects to nominate a pre-clinical candidate corrector before year end 2014. 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
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