TG Therapeutics Announces Additional Data Presentations for BRIUMVI (ublituximab-xiiy) in Multiple Sclerosis at the American Academy of Neurology 2024 Annual Meeting

NEW YORK, April 18, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced two additional data presentations from the ULTIMATE I & II Phase 3 trials evaluating BRIUMVI (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS), at the 2024 American Academy of Neurology (AAN) annual meeting, being held in Denver, Colorado. Links to the data presented yesterday are included below.

Michael S. Weiss, Chief Executive Officer and Chairman of TG Therapeutics stated “The data presented this week during the AAN annual meeting emphasizes our commitment to research and the multiple sclerosis community. We look forward to continuing to evaluate date from the ULTIMATE Phase 3 trials and presenting additional exploratory data throughout the year.”

Link to Poster Presentation: Ublituximab Significantly Reduces Radiological Disease Activity at 12 Weeks: Post-hoc analysis of Participants with Highly Active Disease in the ULTIMATE I & II Phase 3 Studies

• Lead Author: Derrick Robertson, MD - University of South Florida (USF) Morsani College of Medicine in Tampa, Florida
  

Link to Poster Presentation: Earlier Initiation of Ublituximab Treatment Is Associated with Improved Disability Outcomes Among Treatment Naïve Participants in ULTIMATE I and II

• Lead Author: Derrick Robertson, MD - University of South Florida (USF) Morsani College of Medicine in Tampa, Florida
  

All data presented at AAN is 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 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 & Neurological Sciences, and Pediatrics at Stanford University. Additional information on these clinical trials can be found at www.clinicaltrials.gov (NCT03277261; NCT03277248).