Data Published in Neurology and Therapy Demonstrate Significant Reductions in Relapse and MRI Activity with BRIUMVI® in People with Highly Active Relapsing Multiple Sclerosis

Core Insights - TG Therapeutics announced significant efficacy results for BRIUMVI (ublituximab-xiiy) in treating highly active relapsing multiple sclerosis (RMS) based on a post hoc pooled analysis of Phase 3 ULTIMATE I and II studies [1][2] Group 1: Efficacy Results - The analysis included 168 participants with highly active disease, showing BRIUMVI reduced the annualized relapse rate (ARR) to 0.145 compared to 0.496 for teriflunomide, a 70.8% relative reduction (P<0.001) [6] - At Week 12, BRIUMVI reduced the least squares mean number of gadolinium-enhancing (Gd+) T1 lesions by 83.3% compared to teriflunomide (0.114 vs 0.683; P<0.001) [6] - Over 96 weeks, Gd+ T1 lesions were reduced by 95.6% with BRIUMVI versus teriflunomide (0.038 vs 0.875; P<0.001) [6] - NEDA-3 rates at Week 12 were 29.5% for BRIUMVI versus 10.1% for teriflunomide, indicating a 4.8-fold higher likelihood of achieving NEDA-3 with BRIUMVI during Weeks 24-96 (77.9% vs 16.4%; P<0.001) [6] Group 2: Study Design and Population - ULTIMATE I and II trials were randomized, double-blind, and included 1,094 patients across 10 countries, with participants receiving either BRIUMVI or teriflunomide for 96 weeks [5][8] - Patients had to have experienced at least one relapse in the previous year or had a T1 gadolinium-enhancing lesion, with an Expanded Disability Status Scale (EDSS) score from 0 to 5.5 at baseline [5] Group 3: Company Overview - TG Therapeutics is focused on developing and commercializing treatments for B-cell diseases, with BRIUMVI approved for various forms of RMS [8][10] - The company emphasizes the importance of early, high-efficacy treatment for patients with aggressive disease, as highlighted by the study results [2][3]