TG Therapeutics Announces Presentation of Data for BRIUMVI at the 2023 European Committee for Treatment and Research in Multiple Sclerosis Annual Meeting

NEW YORK, Oct. 11, 2023 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) today announced the presentation of data from both 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 2023 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) annual meeting, being held in Milan, Italy. A link to each presentation is included below.

Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics, stated, “The exploratory data from the ULTIMATE I & II trials evaluating BRIUMVI in patients with relapsing forms of MS continues to be exciting and highlights the unique attributes of BRIUMVI. Today at the ECTRIMS annual meeting, we were also excited to present the first data from the ENHANCE trial evaluating patients who switch from an IV anti-CD20 antibody to BRIUMVI.”

PRESENTATIONS:
Poster Presentation Title: Ublituximab Reduces Thalamic Volume Loss and New Lesion Formation in Participants of the ULTIMATE I & II Phase 3 Studies

• Lead Authors: Doug Arnold, MD - NeuroRx Research, Montreal, Canada and Bruce Cree, MD, PhD UCSF, San Francisco, California, USA
  

ePoster Presentation Title: Evaluating the Maintenance of Efficacy and Tolerability when Transitioning from IV anti-CD20 Therapy to Ublituximab: ENHANCE Study Design, Patient Demographics and Preliminary Data

• Lead Author: John Foley, MD - Rocky Mountain Multiple Sclerosis, Salt Lake City, UT, USA
  

The above referenced presentations are also available within the Publications 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 and Neurological Sciences, Pediatrics and Genetics, at Stanford University. Additional information on these clinical trials can be found at www.clinicaltrials.gov (NCT03277261; NCT03277248).