Positive Results for Ublituximab in Phase 2 Clinical Trial
Patients with relapsing-remitting multiple sclerosis (RRMS) who were treated with ublituximab (TG Therapeutics, New York, NY) (n = 46) had rapid depletion of B cells, reduced disease activity on MRI, markedly lower relapse rate, and disability stability. Ublituximab (UTX) is a novel glycoengineered antibody to CD20 that can be delivered via a 1-hour infusion.
At week 4, median B-cell depletion for those treated with UTX was >99% and this was maintained at weeks 24 and 48 for all doses and infusion times. For patients treated with UTX the number of T1-Gd enhancing lesions was reduced by 100% (from 3.63 to 0) by week 24, which was maintained at week 48 (P = .003). Mean T2 lesion volume was decreased by 7.3% at week 24 (P = .006) and by 10.9% from baseline at week 48 (P = .019). At week 48, 93% of those treated with UTX had no relapses and the annualized relapse rate (ARR) was .07. Confirmed disability improvement occurred in 17% of patients treated with UTX and disability worsened in 7%.
In the phase 2 placebo controlled multicenter study (TG1101-RMS201), patients received 3 infusions of UTX or placebo on days 1 and 15 and again at 24 weeks and then followed for another 24 weeks. Levels of B-cell depletion and safety and tolerability were measured for all participants across 6 dosing cohorts that used 450 mg or 600 mg with infusion times from 1 to 4 hours. These data were presented at the American Conference on Treatment and Research in MMS (ACTRIMS) conference in Dallas, TX February 28-March 1.