Galapagos Completes Recruitment for Darwin 2 Monotherapy Study
News Nov 24, 2014
Galapagos NV announces that recruitment of rheumatoid arthritis (RA) patients for the Darwin 2 study with GLPG0634 has been completed. The Darwin Phase 2B program is now fully recruited and will begin a series of topline readouts starting around end of the first quarter 2015.
Selective JAK1 inhibitor GLPG0634 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) of 875 RA patients and in a Phase 2 study in 180 patients with Crohn's disease.
"Completion of recruitment for the Darwin Phased 2B program puts us well on our way toward having Galapagos' first novel mode-of-action medicine tested in 1,000 patients," said Dr Piet Wigerinck, Chief Scientific Officer of Galapagos. "Recruitment for Darwin 2 accelerated to close out recruitment just weeks after DARWIN 1, putting us in position to have topline results from 12 weeks of treatment in Darwin 2 in the second quarter of 2015. With Darwin 2 we will learn the effect of once-daily treatment with GLPG0634 alone. Current standard treatment is a combination of methotrexate with TNFa biologics."
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. Topline results from 12 weeks are expected in April 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.