DX71
Phase 2 Multicenter Study Results of Ublituximab, a Novel Glycoengineered Anti-CD20 Monoclonal Antibody (mAb), in Patients with Relapsing Forms of Multiple Sclerosis (RMS)
Objectives: To assess the B-cell depletion, safety, clinical and radiological efficacy and changes in the immune cell dynamics of ublituximab in RMS subjects.
Methods: TG1101-RMS201 is a 52-week, Phase 2, placebo-controlled, multicenter study designed to assess the optimal dose and infusion time of ublituximab in RMS subjects. All subjects, including placebo subjects (post-placebo phase), receive 3 ublituximab infusions at Day 1, Day 15, and Week 24.
Results: All subjects (24/24) exceeded the target level of 95% B-cell depletion within 4 weeks of ublituximab treatment. Additional detailed immunological analyses showed novel, transient modulatory effects on T-cell populations. To date, 11 of 24 subjects have completed all assessments in the 52-week trial. 87% remain relapse-free at 52 weeks (from a baseline mean of 1.42±1.1 relapses) and 81% are confirmed to be disability progression free. There was a 100% reduction of T1-Gd enhancing lesions at 52 weeks (baseline = 2.4 lesions (mean); p=0.004). The most common adverse event (AE) was IRRs (all grade 1 or 2, in 17% of subjects). No severe AEs were associated with ublituximab treatment. No correlation between faster infusion time (as low as 1 hour) and increased IRR frequency was observed.
Conclusions: The Phase 2 results suggest that ublituximab, with infusion times as low as one hour, is safe and well tolerated, with favorable clinical and MRI outcomes at 1 year. We will be reporting the data set for all subjects at the date of presentation.