TG Therapeutics: TG Therapeutics Announces Data Presentations for BRIUMVI in Multiple Sclerosis at the American Academy of Neurology 2025 Annual Meeting

NEW YORK, April 08, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX), today announced the presentation of data highlighting BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS), at the American Academy of Neurology 2025 annual meeting. Links to each presentation are included below.Michael S. Weiss, Chief Executive Officer and Chairman of TG Therapeutics stated, "We were pleased to share three presentations yesterday which we believe demonstrate our continued commitment to improving the patient experience and understanding the long term and real-world profile of BRIUMVI." Mr. Weiss continued, "The results of the retrospective ENAMOR survey, which includes data from approximately 400 individuals across 21 MS centers who have been treated with BRIUMVI in the real-world setting, showed a favorable tolerability profile, including a lower rate of infusion related reactions at the first BRIUMVI dose than was observed in the ULTIMATE Phase 3 trials. Interestingly, approximately 90% of surveyed patients were given acetaminophen as a pre-medication in this real-world setting, whereas it was excluded as a premed as per protocol in the ULTIMATE Phase 3 trials potentially offering a rationale for the lower rate of infusion related reactions observed. We plan to further evaluate the efficacy and tolerability of BRIUMVI in the real world setting through the ENABLE Phase 4 96-week observational study which will enroll approximately 500 patients across approximately 100 MS centers in the United States. Lastly, we were encouraged to see in the presentation by Dr. Steinman, that after five years of BRIUMVI treatment, the frequency of serious infections remained consistent with the ULTIMATE Phase 3 trials and there were no observed cases of PML."TG PRESENTATIONS:Poster Title: Retrospective Evaluation of Infusion Tolerability: Ublituximab Real-World Observational Survey (ENAMOR)Lead Author: Dr. Ed Fox - TG Therapeutics - National Physician Liaison - VP, MS Global OperationsPoster Title: ENABLE: The First Phase 4 Observational Study for Patients with Relapsing MS Treated with Ublituximab in Real World Clinical SettingLead Author: Dr. Ed Fox - TG Therapeutics - National Physician Liaison - VP, MS Global OperationsPoster Title: No Association Between Decreases in Serum Immunoglobulin (Ig) Levels Below Lower Limit of Normal (LLN) and Serious Infections (SI) with Long-term Ublituximab (UBL) Treatment in Patients with Relapsing Multiple Sclerosis (RMS)Lead Author: Lawrence Steinman, MD, Standford University, Standford, CAThe 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 TRIALSULTIMATE 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 IVBRIUMVI 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 INFORMATIONContraindications: BRIUMVI is contraindicated in patients with:Active Hepatitis B Virus infectionA history of life-threatening infusion reaction to BRIUMVIWARNINGS AND PRECAUTIONSInfusion Reactions: BRIUMVI can cause infusion reactions, which can include ...Full story available on Benzinga.com