TG Therapeutics Reports on Phase 3 Studies of Drug for Relapsing MS
Commercial stage biopharmaceutical company, TG Therapeutics (Nasdaq: TGTX), has presented data from its 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. The company also plans to highlight data from the same studies at the American Academy of Neurology 2024 annual meeting which will take place in April 2024.
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.
Michael S. Weiss, Chief Executive Officer and Chairman of TG Therapeutics stated, “We were pleased to present updated data from the ENHANCE trial 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.”
TG Therapeutics’ ULTIMATE I & II trials 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. The studies enrolled a total of 1,094 patients with RMS across 10 countries.
ABOUT TG THERAPEUTICS
TG Therapeutics is a fully integrated, commercial stage, biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG has received U.S. Food and Drug Administration (FDA) approval for BRIUMVI® (ublituximab-xiiy), for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval by the European Commission (EC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features in Europe and the United Kingdom, respectively. For more information, visit www.tgtherapeutics.com, and follow us on X (formerly Twitter) @TGTherapeutics and on LinkedIn.
