Ublituximab (also known as TG-1101)

Experimental Medications: Monoclonal Antibody Medications

Company: TG Therapeutics

  • Given via IV infusion; dosing to be determined
  • Being studied in RMS

Previous: Ofatumumab | Next: Siponimod

Like Ocrevus, Rituxan, and ofatumumab, ublituximab targets the CD20 molecule in order to deplete B cells. Its developer, TG Therapeutics, is evaluating the monoclonal antibody for use in treating both hematological malignancies and relapsing forms of MS. One area of inquiry in MS is whether the activity of ublituximab will enable it to be administered in lower doses and shorter infusion times than currently available anti-CD20 agents.47

The initial results of a 52-week, multi-center Phase II study of this medication were reported at the October 2017 Joint ECTRIMS-ACTRIMS Meeting. The study was designed to assess the safety, tolerability, and optimal dose and infusion time of ublituximab. Participants were randomized to ublituximab or placebo for 28 days, receiving infusions on Day 1 and Day 15. Participants randomized to placebo then received ublituximab after the 28-day observational period and were followed for 52 weeks.47

The data pertained to 16 study participants up to Week 24 of the 52-week study. At Week 4, ublituximab-treated patients had 99-percent median B-cell depletion from baseline, with that depletion maintained to Week 24. During the first 24 weeks of the study, no participants reported relapses; 83 percent of participants had at least one relapse in the year prior to screening.47

No gadolinium-enhancing lesions were found on MRI in any of the participants at Week 24, and no serious adverse events or clinically significant laboratory abnormalities were reported. Ublituximab also was infused at a faster rate than that employed for other CD20-targeting agents, including infusing 450 mg of the medication in one hour, without an increased frequency of infusion-related reactions.47

In fall 2017, TG Therapeutics opened enrollment for two Phase III trials that will further evaluate the safety and efficacy of ublituximab. ULTIMATE I and ULTIMATE II are global, randomized, multi-center, double-blinded studies comparing ublituximab to Aubagio in people with relapsing forms of MS. Each trial will enroll roughly 440 individuals who will be randomized in a 1:1 ratio. The primary endpoint for both studies is the annualized relapse rate (ARR) following 96 weeks of treatment.48

Previous: Ofatumumab (also known as Arzerra®) | Next:  Siponimod (BAF312)