TG Therapeutics Announces Presentation of Data for BRIUMVI in Multiple Sclerosis at the Americas Committee for Treatment and Research in Multiple Sclerosis Annual Forum

NEW YORK, March 01, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the presentation of data from the ULTIMATE I & II Phase 3 trials and the ENHANCE Phase 3b trial evaluating BRIUMVI (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS), at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) annual forum, being held in West Palm Beach, Florida. Links to each presentation are included below.

Michael S. Weiss, Chief Executive Officer and Chairman of TG Therapeutics stated, “We were pleased to present updated data from the ENHANCE trail evaluating patients switching from a current CD20 to BRIUMVI. It was encouraging to see that patients who switched to one-hour BRIUMVI experienced a manageable safety and tolerability profile. We look forward to continuing to present updated data from this trial throughout the year.”

Poster Presentation: MS Relapse Redefined: Addressing the Radiological/Pseudoexacerbation Paradox with High Efficacy Therapy in the ULTIMATE I and II Trials

• Lead Author: Enrique Alvarez, MD, PhD, University of Colorado, Aurora, CO
  

Poster Presentation: Evaluating the Maintenance of Efficacy and Tolerability of Transitioning from IV Anti-CD20 Therapy to Ublituximab: ENHANCE Study Interim Data

• Lead Author: Barry Singer, MD, The MS Center for Innovations in Care - Missouri Baptist Medical Center, St. Louis, MO
  

The above presentations 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 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).