SUMMARY: A potential treatment for relapsing multiple sclerosis (MS) - ublituximab - was evaluated in phase three clinical trials. The results from the clinical trials indicate that people with relapsing MS who took ublituximab had lower risk of relapses and fewer brain lesions in comparison to the current MS treatment, teriflunomide.
The investigational therapy, ublituximab, was evaluated in phase three clinical trials to test its safety and efficacy as a potential treatment for relapsing MS (see here for more details on ublituximab). Two identical phase three, double-blind, double-placebo, multicenter clinical trials were performed (ULTIMATE I and ULTIMATE II) comparing ublituximab to teriflunomide, a currently approved MS therapy. The clinical trials recruited a total of 1,094 participants with relapsing MS, including those with relapsing-remitting MS and secondary progressive MS, across 104 sites in 10 countries. Participants were randomly assigned to one of the following treatment arms:
- Intravenous ublituximab (four-hour infusion of 150 mg on day 1, followed by one-hour infusions of 450 mg on day 15, weeks 24, 48, and 72) in addition to an oral placebo
- Oral teriflunomide (14 mg once daily from day 1 to week 95) in addition to an intravenous placebo
The primary outcome of the study was to evaluate annualized relapse rate, the number of confirmed relapses per participant per year. Secondary outcomes included number of new brain lesions on magnetic resonance imaging (MRI) by end of study (96 weeks) and disability worsening in people with relapsing MS.
The clinical trial found that participants receiving ublituximab experienced fewer relapses and had lower number of brain lesions on MRI compared to participants receiving teriflunomide at 96 weeks. The study did not find a significant reduction in the risk of disability worsening. Participants in the ublituximab treatment arm had a higher frequency of infections, with infusion-related infections being the most common, in comparison to those in the teriflunomide treatment arm. Other infections included nasopharyngitis, respiratory tract infections, pharyngitis, urinary tract infections, and herpes virus-associated infections. A total of three deaths were reported in the ublituximab treatment arm, all of which were related to a serious infection. No cases of progressive multifocal leukoencephalopathy (PML), a viral brain disease, were reported.
TG Therapeutics, a biopharmaceutical company focused on developing novel treatments for B-cell diseases and a sponsor of the study, reports they are currently seeking US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approval of ublituximab for the treatment of relapsing forms of MS in adults. Further updates will be provided on this potential new therapeutic.
References:
Article published in New England Journal of Medicine – Ublituximab versus Teriflunomide in Relapsing Multiple Sclerosis. Link to article – here.
Press release by TG Therapeutics – TG Therapeutics Announces Results from the ULTIMATE I & II Phase 3 Trials of Investigational Ublituximab in RMS Published in The New England Journal of Medicine. Link to press release – here.