New Data: 30-Minute Infusions of BRIUMVI® Well Tolerated in Relapsing MS

TG Therapeutics, Inc. has shared promising updated data from the ENHANCE Phase 3b trial of BRIUMVI® (ublituximab-xiiy) at the 2024 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) annual meeting. This trial focuses on patients with relapsing forms of multiple sclerosis (RMS).

Michael S. Weiss, Chairman and CEO of TG Therapeutics, expressed enthusiasm about the findings, which aim to optimize the dosing regimens for BRIUMVI. The study initially centered on patients transitioning from other anti-CD20 therapies in a B-cell depleted state. Notably, these patients were able to successfully switch to BRIUMVI without the initial 150 mg, 4-hour infusion. The latest data also explores faster infusion times, reducing them from one hour to as little as 30 minutes starting at week 24. These rapid infusions were achieved without post-infusion observation time, adhering to the BRIUMVI prescribing information.

The ENHANCE trial is a multi-center, open-label study spanning 48 weeks. It aims to evaluate optimized dosing regimens through two key objectives: eliminating the initial 150 mg BRIUMVI infusion for B-cell depleted patients and exploring shorter durations for the subsequent 450 mg infusions. The findings indicate that the 450 mg dose can be safely administered in one hour, with 97% of infusions completed without interruptions. Moreover, 12 patients received the 450 mg BRIUMVI infusions in 30 minutes at week 24, all of which were completed smoothly. Infusion-related reactions were mild, with only two Grade 1 instances.

The study's data bolster the possibility of administering BRIUMVI more efficiently while maintaining safety and efficacy. This could significantly enhance patient convenience and tolerability, potentially leading to label-enabling studies with regulatory agencies.

In parallel, the ULTIMATE I & II trials are two randomized, double-blind, parallel-group clinical trials evaluating BRIUMVI against teriflunomide in patients with RMS over 96 weeks. The trials enrolled 1,094 patients across 10 countries and were spearheaded by Dr. Lawrence Steinman of Stanford University. Patients were randomized to receive either BRIUMVI or teriflunomide, with the former showing promising results in reducing relapses and improving patient outcomes.

BRIUMVI (ublituximab-xiiy) is a monoclonal antibody targeting a specific epitope on CD20-expressing B-cells, offering an effective therapeutic approach for RMS. The glycoengineered nature of BRIUMVI ensures efficient B-cell depletion at low doses. It is indicated for treating adults with various relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

TG Therapeutics, a biopharmaceutical company, is committed to developing and commercializing novel treatments for B-cell diseases. With FDA approval for BRIUMVI in the U.S. and additional approvals in Europe and the U.K., the company is establishing a strong foothold in the market.

Patients treated with BRIUMVI should be aware of certain safety concerns. Infusion reactions, infections, and potential Hepatitis B Virus (HBV) reactivation are among the primary risks. Proper pre-medication and monitoring are recommended to mitigate these risks. No cases of progressive multifocal leukoencephalopathy (PML) have been reported with BRIUMVI, though vigilance is advised given its occurrence with other anti-CD20 therapies.

For healthcare professionals and patients, comprehensive support programs are available to ensure a smooth treatment journey with BRIUMVI. The company remains focused on advancing its research pipeline to offer better solutions for patients with B-cell diseases.

In summary, the updated data from the ENHANCE study enhances the potential of BRIUMVI as a more convenient and effective treatment for RMS, underscoring TG Therapeutics' commitment to improving patient care in the realm of multiple sclerosis.