Galapagos RA drug meets endpoint in Phase II study
Mechelen – Belgian drugmaker Galapagos NV has reported impressive results of a proof-of-concept trial with its oral janus kinase 1 blocker GLPG0634 + Methothrexate in patients with active rheumatoid arthritis. In the 24 patients that were enrolled in a once daily and twice daily arm, the daily 200 mg dose was well-tolerated over 4 weeks. There were no safety signals as in the 12 patients receiving *the standard-of-care treatment Methothrexate plus placebo*. Additionally, GLPG0634 significantly improved ACR20 and ACR50 and significantly reduced the level of inflammation markers such as CRP and DAS28. In detail, ACR 20 reduction was observed in 83,3% (placebo 33,3%) of the 24 RA patients receiving the JAK1 inhibitor. ACR50 reduction was seen in 41,7% (placebo 8.3), and ACR70 reduction in 20.8% (placebo 0%, not significant). Most improvements occurred just one week after start of the treatment and in the group that received the drug twice daily. *Galapagos announced plans to initiate an extended dose-range finding study for GLPG0634 in the first half of 2012 to further define the optimal doses for efficacy and safety. Currently, the programme is not partnered.