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TG Therapeutics Announces Data from the ULTIMATE I & II Phase 3 Trials of BRIUMVI (ublituximab-xiiy) in Multiple Sclerosis to be Presented at the 2023 Consortium of Multiple Sclerosis Centers Annual Meeting
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0 KommentareNEW YORK, May 31, 2023 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the details of an upcoming oral presentation, highlighting data from the ULTIMATE I & II Phase 3 trials evaluating BRIUMVI (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS), to be presented at the upcoming Consortium of Multiple Sclerosis Centers (CMSC) annual meeting, being held May 31 - June 4, 2023, in Aurora, Colorado. The abstract is now available online and can be accessed on the International Journal of MS Care (IJMSC) website at www.ijmsc.org, or by following this direct link: https://doi.org/10.7224/1537-2073-25.s1.1. Details of the presentation are included below.
Oral Presentation: Ublituximab Is Associated with Significant Improvement in Fatigue: Results from Ultimate I and II
- Presentation Date/Time: Thursday, June 1, 2023/ 3:20 – 3:40 PM MT
- Session: Disease Modifying Therapies – Summit 6-7
- Presentation ID: DMT02
- Lead Author: Enrique Alvarez, MD, University of Colorado, Aurora, CO
Following the presentation, the data will be available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com/publications.cfm.
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ABOUT THE ULTIMATE I & II PHASE 3 TRIALS
ULTIMATE I & II are two randomized, double-blind, double-dummy, parallel group, active comparator-controlled clinical trials
of identical design, in patients with RMS treated for 96 weeks. Patients were randomized to receive either BRIUMVI, given as an IV infusion of 150 mg administered in four hours, 450 mg two weeks
after the first infusion administered in one hour, and 450 mg every 24 weeks administered in one hour, with oral placebo administered daily; or teriflunomide, the active comparator, given orally as
a 14 mg daily dose with IV placebo administered on the same schedule as BRIUMVI. Both studies enrolled patients who had experienced at least one relapse in the previous year, two relapses in the
previous two years, or had the presence of a T1 gadolinium (Gd)-enhancing lesion in the previous year. Patients were also required to have an Expanded Disability Status Scale (EDSS) score from 0 to
5.5 at baseline. The ULTIMATE I & II trials enrolled a total of 1,094 patients with RMS across 10 countries. These trials were led by Lawrence Steinman, MD, Zimmermann Professor of Neurology
and Neurological Sciences, Pediatrics and Genetics, at Stanford University. Additional information on these clinical trials can be found at www.clinicaltrials.gov (NCT03277261; NCT03277248).
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