Sanofi-Aventis and Regeneron Pharmaceuticals have reported clinical results from two Phase IIb studies of Sarilumab in rheumatoid arthritis and ankylosing spondylitis patients.
Sarilumab is a novel, high-affinity, subcutaneously administered, fully-human antibody that targets the interleukin-6 receptor.
The 306 patient, dose-ranging, multi-national, randomised, multi-arm, double-blind and placebo-controlled MOBILITY trial demonstrated that patients treated with Sarilumab in combination with methotrexate achieved improvement in signs and symptoms of rheumatoid arthritis at 12 weeks.
Sanofi-Aventis global research and development president Elias Zerhouni said that the companies are discussing the dosage of Sarilumab to advance into the Phase III portion of the MOBILITY trial.
Another randomised, double-blind, placebo-controlled, dose ranging study including 300 patients, known as ALIGN, showed the drug did not demonstrate significant and clinically meaningful improvements in signs and symptoms of active ankylosing spondylitis compared to a placebo.