RIGEL BEGINS PHASE II TRIAL OF SYK KINASE INHIBITOR
Rigel Pharmaceuticals has initiated enrollment and dosing in a Phase II study evaluating the efficacy and safety of its lead product candidate, R788, an oral syk kinase inhibitor, for the treatment of patients with rheumatoid arthritis.
This multicenter, randomized, double-blind, placebo-controlled, ascending-dose, dose-ranging study will evaluate up to three doses of R788. The study is expected to enroll approximately 180 patients in the U.S. who have had rheumatoid arthritis for a minimum of 12 months and who have active disease despite receiving adequate doses of methotrexate. The primary endpoint of this study is to determine the percent of ACR 20 responders at the end of 12 weeks. An ACR 20 response requires at least a 20 percent improvement in a number of different measures of disease activity and is one of the standard measures to assess efficacy in rheumatoid arthritis clinical trials. Secondary endpoints include other measures of disease activity as well as safety.
R788 blocks the activation of mast cells, macrophages and B cells that promote swelling and an inflammatory response. Phase I trial results have demonstrated that R788 is well-tolerated and showed good pharmaceutical properties when administered both alone and in combination with methotrexate.
Upcoming Events
-
21Oct