Ublituximab is a monoclonal antibody that specifically targets CD20, a protein that is found on the surface of white blood cells called B lymphocytes or B cells. Ublituximab acts as an immunomodulatory drug that targets and removes potentially harmful B cells in the blood and central nervous system of people with MS.
A phase II, double-blind, placebo-controlled, multi-centre clinical trial recruited 48 people with relapsing MS to examine the safety, tolerability and optimal dosing regimen of ublituximab. Participants were randomized to receive either ublituximab (150 mg infusion on day 1, 450 mg infusion on day 15, followed by either 450 or 600 mg at week 24) or placebo. The trial results showed that ublituximab was well-tolerated by study participants with no serious adverse events reported. The treatment also demonstrated a median B-cell depletion of 99% by week 4, and was maintained until 48 weeks post-treatment.
The ULTIMATE studies are phase III, randomized, double-blind, multi-center trials testing the safety and tolerability of ublituximab compared with Aubagio (teriflunomide). The trials recruited a total of 1094 adults with active relapsing forms of MS that were randomly assigned to receive either ublituximab (four-hour infusion of 150 mg on day 1, one-hour infusion of 450 mg on day 15, followed by one-hour infusion of 450 mg every 6 months) or oral Aubagio (14 mg once daily) for 96 weeks. Top-line data from the trials showed that ublituximab was superior to Aubagio in lowering the frequency of relapses in people with relapsing MS by 50-60%. Additional findings will be released in 2021.
Fox E et al. A phase 2 multicenter study of ublituximab, a novel glycoengineered anti-CD20 monoclonal antibody, in patients with relapsing forms of multiple sclerosis. Mult Scler. 2020; 27(3): 420-429.
TG Therapeutics, Inc. TG Therapeutics announces positive topline results from the ULTIMATE I & II Phase 3 studies evaluating ublituximab monotherapy for the treatment of patients with multiple sclerosis. 2020; retrieved from TG Therapeutics Press Release.