Galapagos NV announced they completed the recruitment phase for patients with rheumatoid arthritis to enroll their Darwin Phase 2B program evaluating GLPG0634 (filgotinib) as a monotherapy for rheumatoid arthritis.
GLPG0634 is a selective inhibitor of JAK1, a key factor in the JAK-STAT signaling pathway, which mediates key inflammatory responses. Rheumatoid arthritis (RA) is a chronic, systemic inflammatory disorder primarily affecting the joints. GLPG0634 Phase 2B program (DARWIN) recruited 875 rheumatoid arthritis patients and 280 patients with moderate to severe rheumatoid arthritis who failed to respond fully to methotrexate. The study results are expected in April of 2015 and will evaluate GLPG0634 monotherapy administered as a three once-daily dose. GLPG0634 is also being evaluated in a Phase 2 study as a treatment for other inflammatory diseases, such as Crohn’s disease.
Dr. Piet Wigerinck, Chief Scientific Officer of Galapagos noted, “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. Recruitment for Darwin 2 accelerated to close out recruitment just weeks after DARWIN 1, putting us in a position to have top line 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.”
Galapagos also plans to enroll 280 participants into DARWIN 2 with moderate to severe RA who had previously failed to respond positively to methotrexate. DARWIN 2 is being designed as a double-blind, placebo-controlled trial that will prescribe three once-daily dose levels of the experimental GLPG0634 therapy as a monotherapy treatment. Topline results from 12 weeks are expected to be ready in April 2015, and a complete 24 week data package is expected to be ready in Q3 2015. AbbVie has announced that it will make a licensing decision on the therapy based on the complete 24 week DARWIN 1 and 2 data packages from GLPG0634 once they are released.