Positive topline results announced from two phase III studies (ULTIMATE I and II) of ublituximab for treatment of relapsing forms of multiple sclerosis

Trials of this anti-CD20 antibody met their primary endpoint of statistically significant reductions in annualised relapse rate over the course of the 96-week trials, compared with teriflunomide. A Biologics License Application to FDA is planned for third quarter of 2021.

SPS commentary:

Patients in ULTIMATE I on ublituximab had an annualised relapse rate (ARR) of 0.076 compared with patients receiving teriflunomide (0.188). The results were similar in ULTIMATE II, with ARRs of 0.091 and 0.178, respectively.

Biospace Inc.