New Data for BRIUMVI® (ublituximab-xiiy) Demonstrate that 92% of Patients with Relapsing Multiple Sclerosis Were Free from Disability Progression After 5 Years of Treatment

During year 5 of treatment with BRIUMVI the annualized relapse rate was 0.020, equivalent to one relapse occurring every 50 years of patient treatment

Overall safety profile of BRIUMVI remained consistent over 5 years of continuous treatment, with no new safety signals emerging with prolonged treatment

NEW YORK, Sept. 18, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced updated data presentations including new five-year 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 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) annual meeting, where we and our partner, Neuraxpharm, are exhibiting. Highlights from the presentations are outlined below.

Bruce Cree, MD, PhD, MAS, Zimmermann Endowed Professor in Multiple Sclerosis, and Professor of Neurology at UCSF Weill Institute for Neurosciences, University of California, San Francisco stated, “The long-term data presented today continues to demonstrate BRIUMVI’s potential for impacting the lives of RMS patients worldwide. The sustained clinical efficacy as illustrated by extremely low rates of relapse and limited disability progression combined with a tolerable safety profile at this 5 year follow up is important for clinicians and patients alike when considering high-efficacy therapy options.”

Michael S. Weiss, the Company’s Chairman and Chief Executive Officer stated, “We are pleased today to present long-term data for BRIUMVI from the open-label extension of our pivotal ULTIMATE I & II Phase 3 studies. These data demonstrate that patients treated with BRIUMVI for up to 5 years had sustained clinical benefit, including further reductions in the risk of relapse in later years of treatment and an impressively low rate of confirmed disability progression. The data further demonstrate that patients who started BRIUMVI early had improved long-term outcomes compared to those who were initially treated with teriflunomide and then switched to BRIUMVI in the open-label extension.”  Mr. Weiss continued, “Importantly, these long-term benefits were observed in the context of a consistent safety profile to that seen in our pivotal studies, with no new safety signals emerging with longer-term treatment. We believe that these data continue to support BRIUMVI’s role as a valuable treatment option for patients with relapsing forms of MS.”

DATA HIGHLIGHTS:

Poster Presentation: Five years of BRIUMVI (ublituximab) in relapsing multiple sclerosis: Results from the open-label extension of ULTIMATE I and II studies                                     

·         Patients who continued BRIUMVI treatment exhibited low and decreasing annualized relapse rate (ARR) throughout the observation period, ARR: 0.053, 0.032, and 0.020 for Years 3, 4, and 5, respectively.

·         During Year 1 of the open label extension (OLE), patients who switched from teriflunomide to BRIUMVI experienced a significant reduction (-58.4%) in ARR (0.182 vs 0.076).

·         After 5 years of continuous BRIUMVI treatment, 8% of patients had Confirmed Disability Progression (CDP) lasting 24 weeks compared to 14.3% of patients who switched from teriflunomide to BRIUMVI [HR (95% CI): 0.612 (0.414, 0.904); p=0.0126], and 92% remained progression free with continuous BRIUMVI treatment.

·         17% of patients treated with BRIUMVI continuously for 5 years achieved Confirmed Disability Improvement (CDI) lasting at least 24 weeks compared to 12.2% of patients who switched from teriflunomide to BRIUMVI [HR (95% CI): 1.472 (1.048, 2.067); p=0.0249], resulting in one in six patients experiencing improvement in disability after 5 years of continuous BRIUMVI treatment.

·         The overall safety profile of BRIUMVI remained consistent over 5 years of continuous treatment in an exposure-adjusted analysis of adverse events (AEs), with no new safety signals emerging with prolonged treatment.

·         Immunoglobulin levels remained stable with prolonged BRIUMVI treatment, and the mean IgM and IgG levels remained above the lower limit of normal. There was no association between decreased immunoglobulin levels and risk of serious infections.

Updated data were also presented from a post-hoc analysis of the ULTIMATE I and II studies.

E Poster Presentation: Comparison of Multiple Sclerosis Disease Activity (MSDA) Test Results Between Patients Treated with BRIUMVI (ublituximab) and Teriflunomide in the Phase 3 ULTIMATE I and II Studies

·         BRIUMVI treatment over 96 weeks resulted in significant average treatment effects versus the teriflunomide arm for the overall Disease Activity Score and each of the 4 Disease Pathway Scores (all scores decrease for the BRIUMVI arm), and 10 individual biomarkers over the duration of the study.

The data presentations are also available on the Publications page, located within the Pipeline section, of the Company’s website at http://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 http://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.

  
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.

BRIUMVI® is a registered trademark of TG Therapeutics, Inc.