TG Therapeutics to Present BRIUMVI Data at 2024 ECTRIMS Annual Meeting

10 September 2024

NEW YORK, Sept. 05, 2024 - TG Therapeutics, Inc. (NASDAQ: TGTX) has unveiled its schedule for upcoming data presentations from its ULTIMATE I & II Phase 3 trials and the ENHANCE Phase 3b trial. These presentations will focus on the evaluation of BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS) and will take place at the 2024 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) annual meeting from September 18-20 in Copenhagen, Denmark.

Presentation Details

Several key presentations are scheduled:

1. Five years of Ublituximab in relapsing multiple sclerosis: additional results from open-label extension of ULTIMATE I and II studies
- Date/Time: September 18, 16.15 – 18.15 CEST
- Session: Poster Session 1 – Room D3
- Abstract Number: 2102/P324
- Lead Author: Dr. Bruce Cree, Weill Institute for Neurosciences, University of California, San Francisco, CA, USA

2. Efficacy and tolerability of ublituximab after transitioning from a different disease modifying therapy: Updates from the ENHANCE study
- Date/Time: September 18, 16.15 – 18.15 CEST
- Session: Poster Session 1 – Room D3
- Abstract Number: 2259/P329
- Lead Author: Dr. John Foley, Rocky Mountain Multiple Sclerosis, Salt Lake City, UT, USA

3. Comparison of Multiple Sclerosis Disease Activity (MSDA) Test Results Between Patients Treated with Ublituximab and Teriflunomide in the Phase 3 ULTIMATE I and II Studies
- Date/Time: September 18, 08:00 CEST
- Session: ePoster (available for 3 months post-congress)
- Abstract Number: 1382/eP1516
- Lead Author: Dr. John Foley, Rocky Mountain Multiple Sclerosis, Salt Lake City, UT, USA

About the ULTIMATE I & II Phase 3 Trials

The ULTIMATE I & II trials are double-blind, double-dummy, parallel group, active comparator-controlled studies that enrolled 1,094 patients with RMS across 10 countries. These trials compared BRIUMVI, an intravenous monoclonal antibody, with teriflunomide, an oral medication. Over 96 weeks, patients received either BRIUMVI or teriflunomide, with the primary measure of effectiveness being the reduction in relapse rates. The studies were directed by Dr. Lawrence Steinman from Stanford University.

About BRIUMVI® (ublituximab-xiiy)

BRIUMVI® is a monoclonal antibody that targets CD20-expressing B-cells, playing a crucial role in managing autoimmune disorders such as RMS. Unlike other treatments, BRIUMVI® is glycoengineered to have enhanced efficiency in depleting B-cells at lower doses.

BRIUMVI® is approved for treating adults with various forms of RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. 

Safety Information

BRIUMVI® can cause infusion reactions and serious infections. Patients must be screened for Hepatitis B Virus before starting treatment, and vaccinations must follow specific guidelines. There are risks related to Progressive Multifocal Leukoencephalopathy (PML) and reduced immunoglobulin levels. Women of childbearing potential should use contraception during treatment and for six months after the last dose due to potential fetal harm.

About Multiple Sclerosis

Relapsing multiple sclerosis is a chronic disease affecting the central nervous system, characterized by relapses followed by recovery periods. It is estimated that around 1 million people in the U.S. have MS, with 85% diagnosed initially with relapsing-remitting MS (RRMS). Worldwide, more than 2.3 million people live with MS.

About TG Therapeutics

TG Therapeutics is committed to developing and commercializing innovative treatments for B-cell diseases. Their FDA-approved product, BRIUMVI®, is now available for treating RMS in the U.S., Europe, and the U.K. The company continues to expand its research pipeline and commercial infrastructure.

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