TGTX - TG Therapeutics Announces Presentation of Data for BRIUMVI® (ublituximab-xiiy) in Multiple Sclerosis at the American Academy of Neurology 2024 Annual Meeting | Benzinga
NEW YORK, April 15, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX), today announced the presentation of data 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. A link to the data presented yesterday is included below. Two additional presentations will be shared on Wednesday April 17, 2024.
Michael S. Weiss, Chief Executive Officer and Chairman of TG Therapeutics stated "The ULTIMATE I & II Phase 3 trials demonstrated robust clinical activity for BRIUMVI compared to teriflunomide and these post-hoc analyses provide interesting new insights and support BRIUMVI's utility as an important treatment option for patients with relapsing forms of multiple sclerosis. We look forward to presenting two additional data sets this week during the AAN annual meeting."
Link to Poster Presentation: MS Relapse Redefined: Distinguishing True Relapses from Pseudoexacerbactions in the ULTIMATE I and II Trials Comparing Ublituximab vs. Teriflunomide
- Lead Author: Stephen Krieger, MD - The Corinne Goldsmith Dickinson Center for MS, The Mount Sinai Hospital NY, NY
UPCOMING PRESENTATIONS AT AAN 2024:
Poster Presentation Title: 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
- Presentation Date/Time: Wednesday, April 17, from 8:00 AM - 9:00 AM MST
- Session: P9: Multiple Sclerosis: Clinical Trials and Therapeutics (including Safety) 2
- Abstract Number/Poster Number: 6023/017 in Neighborhood 6
- Lead Author: Derrick Robertson, MD - University of South Florida (USF) Morsani College of Medicine in Tampa, Florida
Poster Presentation Title: Earlier Initiation of Ublituximab Treatment Is Associated with Improved Disability Outcomes Among Treatment Naïve Participants in ULTIMATE I and II
- Presentation Date/Time: Wednesday, April 17, from 8:00 AM - 9:00 AM MST
- Session: P9: Multiple Sclerosis: Clinical Trials and Therapeutics (including Safety) 2
- Abstract Number/Poster Number: 6400/001 in Neighborhood 6
- Lead Author: Derrick Robertson, MD - University of South Florida (USF) Morsani College of Medicine in Tampa, Florida
Following the presentations, the data presented will be 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).
ABOUT BRIUMVI® (ublituximab-xiiy) 150 mg/6 mL Injection for IV
BRIUMVI is a novel monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for the management of autoimmune disorders, such as RMS. BRIUMVI is uniquely designed to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, allows for efficient B-cell depletion at low doses.
BRIUMVI is indicated for the treatment of adults with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
A list of authorized specialty distributors can be found at www.briumvi.com.
IMPORTANT SAFETY INFORMATION
Contraindications: BRIUMVI is contraindicated in patients with:
- Active Hepatitis B Virus infection
- A history of life-threatening infusion reaction to BRIUMVI
WARNINGS AND PRECAUTIONS
Infusion Reactions: BRIUMVI can cause infusion reactions, which can include pyrexia, chills, headache, influenza-like illness, tachycardia, nausea, throat irritation, erythema, and an anaphylactic reaction. In MS clinical trials, the incidence of infusion reactions in BRIUMVI-treated patients who received infusion reaction-limiting premedication prior to each infusion was ...