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TG Therapeutics Announces Presentation of Data from the ULTIMATE I & II Phase 3 Trials of BRIUMVI® (ublituximab-xiiy) in Multiple Sclerosis at the American Academy of Neurology 75th Annual Meeting
NEW YORK, April 25, 2023 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced presentations highlighting data from the ULTIMATE I & II
About this update from Tg Therapeutics, Inc.
[{"type":"text","content":"NEW YORK, April 25, 2023 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced presentations highlighting data from the ULTIMATE I & II Phase 3 trials evaluating BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS), at the American Academy of Neurology (AAN) annual meeting. Links to each of the presentations are below.Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics stated, “We are pleased to present additional analyses from the ULTIMATE I & II Phase 3 trials and further in-vitro characterization of BRIUMVI at the AAN conference this week. We look forward to continuing to share additional exploratory analyses throughout the year.” Poster Presentation: Ublituximab Efficacy in Treatment-Naive Participants With Relapsing Multiple Sclerosis in the Phase 3 ULTIMATE I and II Studies Lead Author: Lawrence Steinman, MD, Stanford University, Stanford, CA Poster Presentation: Disease Outcomes With Ublituximab in Participants With Highly Active Disease: Subpopulation Analyses of the Phase 3 ULTIMATE I and II Studies in Participants With Relapsing Multiple Sclerosis Lead Author: Enrique Alvarez, MD, PhD, University of Colorado, Aurora, CO Poster Presentation: Ublituximab, a Novel, Glycoengineered Anti-CD20 Monoclonal Antibody (mAb), Demonstrates Enhanced Antibody-Dependent Cellular Cytotoxicity (ADCC) Relative to Other Anti-CD20 mAbs Lead Author: John Foley, MD, Rocky Mountain Multiple Sclerosis Clinic, Salt Lake City, UT The data presented are also available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com/publications.cfm. ABOUT THE ULTIMATE I & II PHASE 3 TRIALSULTIMATE 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 experie...