Ublituximab continues to be safe and well-tolerated by people with relapsing forms of multiple sclerosis (MS) after a median follow-up of 124.7 weeks — more than 2 years — according to data from an extension Phase 2 trial.
The data were shown in a poster titled “Long-term Follow-up Results from the Phase 2 Multicenter Study of Ublituximab (UTX), a Novel Glycoengineered Anti-CD20 Monoclonal Antibody (mAb), in Patients with Relapsing Multiple Sclerosis (RMS),” at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), held Sept. 11-13 in Stockholm, Sweden.
Ublituximab, developed by TG Therapeutics, is a monoclonal antibody designed to target the CD20 antigen of mature B-cells, leading to the elimination of these immune cells from the blood and central nervous system. B-cells play a key role in MS development. According to the company, ublituximab has superior potency compared with current anti-CD20 antibodies, which may enable the use of lower doses and shorter infusion times.
The multicenter, placebo-controlled Phase 2 trial (NCT02738775) assessed ublituximab’s optimal dose, infusion time, safety, and tolerability in patients with relapsing MS.
All participants — 48 patients, mean age of 40 years — received ublituximab infusions or a placebo on days 1 and 15, and at week 24, and then were followed for 48 weeks.
To determine optimal dose and infusion time for ublituximab, B-cell depletion as well as safety and tolerability were compared among six dosing groups — 450 mg or 600 mg dose, and infusion times between one and four hours.
Prior results showed that ublituximab reduced B-cells by 99%, together with the full regression of MRI (magnetic resonance imaging) lesion, after only four weeks of treatment in people with relapsing MS.
Now, new data at week 48 showed that 93% of patients were relapse free (annualized relapse rate of 0.07), and 74% showed no evidence of disease activity (NEDA). In addition, no MRI lesions were detected at week 24 or 48.
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