TG Therapeutics is set to present comprehensive data on BRIUMVI® (ublituximab-xiiy) at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) annual forum, taking place February 27 – March 1, 2025, in West Palm Beach, Florida.
Clinical Trial Updates and Real-World Evidence
The presentations will highlight findings from multiple studies, including the pivotal ULTIMATE I & II Phase 3 trials and the ENHANCE Phase 3b trial. Dr. John Foley from Rocky Mountain Multiple Sclerosis will present new safety and tolerability data for 30-minute BRIUMVI infusions from the ENHANCE study, addressing an important aspect of treatment administration efficiency.
Real-world experience data from a single U.S. MS center will provide valuable insights into BRIUMVI's performance in clinical practice. Additionally, researchers will present findings comparing disease activity trajectories between BRIUMVI and teriflunomide using the MSDA Test, potentially offering new perspectives on treatment outcomes.
Novel Mechanism and Trial Design
BRIUMVI represents an innovative approach in MS treatment as a glycoengineered anti-CD20 monoclonal antibody. The removal of specific sugar molecules from the antibody enables efficient B-cell depletion at lower doses, potentially offering advantages over existing therapies.
The ULTIMATE I & II trials were rigorously designed as randomized, double-blind, double-dummy studies comparing BRIUMVI to teriflunomide. The trials included patients who had experienced at least one relapse in the previous year or two relapses in the previous two years, with baseline EDSS scores ranging from 0 to 5.5.
Treatment Protocol and Administration
The BRIUMVI treatment regimen consists of:
- Initial 150 mg IV infusion administered over four hours
- 450 mg dose two weeks later administered over one hour
- Subsequent 450 mg doses every 24 weeks administered over one hour
Clinical Impact and Market Significance
Multiple sclerosis affects nearly 1 million people in the United States alone, with approximately 85% initially diagnosed with relapsing-remitting MS. BRIUMVI's approval for treating relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, positions it as an important addition to the treatment landscape.
The drug's development represents a significant advancement in MS therapy, particularly given the unmet needs in the field. The upcoming presentations at ACTRIMS will provide healthcare professionals with crucial information about BRIUMVI's efficacy, safety profile, and real-world performance, helping inform treatment decisions for patients with relapsing forms of MS.
