HomeNewsms, multiple sclerosis, TG Therapeutics, ublituximabPh 2 data for Ublituximab shows encouraging efficacy results in RMS patients

Ph 2 data for Ublituximab shows encouraging efficacy results in RMS patients

  • June 7, 2018
  • Posted by: PharmaScroll
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Phase 2 trial results for TG Therapeutics’ Ublituximab, presented at 2018 CMSC Annual Meeting, displayed superior efficacy results in lowering relapses and efficiently depleting B Cells in patients.

In the study, 48 subjects were randomized to treatment in Cohort 1 through Cohort 6 and 46/48 subjects completed 6 months of ublituximab treatment; 12 (2 per cohort) received placebo infusions, before crossing over to the ublituximab arm. One subject in Cohort 2 withdrew from the study due to pregnancy, after having received 2 ublituximab infusions, but continued to be followed with safety lab monitoring and immunological analyses. One subject in Cohort 6 missed the week 24 infusion, and later withdrew.

Results of the study:

The researchers highlighted the following observations and findings after the conclusion of the study.

  • B-cells were efficiently depleted in most patients within 24 hours of receiving the first dose of ublituximab, with >99% depletion in all patients by Week 4, and significant reductions from baseline maintained at Week 24.
  • Ublituximab was well tolerated and the most frequent AEs were infusion related reactions (IRRs); all Grade 1 or 2
  • A rapid infusion time, as low as one hour, of 450mg was well tolerated, produced high levels of B cell depletion and would now be studied in the Phase 3 ULTIMATE trials.
  • An Annualized Relapse Rate (ARR) of 0.05 was observed at Week 24.
  • No T1 Gd-enhancing lesions were detected in any subjects at Week 24
  • 67% Reduction in T2 lesion volume at Week 24 from baseline, suggestive of a decrease in burden of disease
  • 98% of subjects were relapse free at Week 24
  • 83% of subjects showing improved or stable EDSS and Mean EDSS improvement from baseline of 0.29

 

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