Biogen reports negative data on natalizumab in Phase III multiple sclerosis trial

US biotech company Biogen (Nasdaq: BIIB) has reported negative data from the Phase III trial of natalizumab, its blockbuster drug Tysabri, in secondary progressive multiple sclerosis.

The ASCEND trial evaluated the safety and efficacy of natalizumab to slow the accumulation of disability progression unrelated to relapse in secondary progressive multiple sclerosis patients, where the majority of study participants had EDSS scores of 6.0 to 6.5 which indicates a walking aid is required. They were non-relapsing for two years prior to enrolling in the study. The composite primary endpoint of the study evaluated the percentage of patients whose disability had progressed on one of more of three disability measurements comprising the composite endpoint. Natalizumab showed a significant effect on upper limb function unrelated to relapses.

Alfred Sandrock, chief medical officer at Biogen, said: “While we’re disappointed with these results, we believe this research will provide the MS community important insights into this more advanced patient population, and the benefits that natalizumab may provide in areas such as upper limb function. Given the challenges of treating this advanced stage of MS, these results underscore the importance of treatment early in the course of disease with effective disease-modifying therapies before a patient advances to SPMS.”