Kyowa starts Phase III of brodalumab in axial spondyloarthritis

Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) began a Phase III trial evaluating subcutaneous Lumicef brodalumab (KHK4827) to treat axial spondyloarthritis. The double-blind, placebo-controlled, Asian trial is evaluating the primary endpoint of the proportion of patients achieving an Assessment of SpondyloArthritis International Society (ASAS) 40 response at week 16 in about 120 patients. Secondary endpoints include safety and pharmacokinetics.

Brodalumab, a human IgG2 mAb against IL-17 receptor (IL17R; IL17RA), is marketed in Japan as Lumicef to treat psoriasis vulgaris, psoriatic arthritis, pustular psoriasis and psoriatic erythroderma. Valeant Pharmaceuticals International Inc. (TSX:VRX; NYSE:VRX) plans to launch the product this month as Siliq in the U.S. to treat moderate to severe plaque psoriasis...