TG Announces Phase 3 Trial for Subcutaneous BRIUMVI Commenced Enrollment

Core Insights - TG Therapeutics has initiated a Phase 3 trial for subcutaneous BRIUMVI (ublituximab-xiiy) targeting relapsing forms of multiple sclerosis (RMS) [1][2] - The trial aims to evaluate the pharmacokinetics, safety, and clinical effects of subcutaneous BRIUMVI compared to the currently approved intravenous (IV) formulation [2][3] - If successful, subcutaneous BRIUMVI could capture a significant portion of the market, particularly the estimated 40% of RMS patients who prefer self-injectable therapies [2] Company Overview - TG Therapeutics is a biopharmaceutical company focused on developing treatments for B-cell diseases, with BRIUMVI approved for RMS in the U.S. and several other regions [27] - The company aims to provide innovative treatment options and enhance patient choice in managing RMS [2][27] Product Information - BRIUMVI is a monoclonal antibody that targets CD20-expressing B-cells, designed to efficiently deplete B-cells at low doses through glycoengineering [3] - The drug is currently administered as a one-hour IV infusion twice a year, and the new subcutaneous option aims to offer greater flexibility for patients [1][2] Clinical Trial Details - The Phase 3 trial is a non-inferiority, randomized, open-label study comparing subcutaneous BRIUMVI administered every 8 weeks and every 12 weeks against the IV regimen [2] - The primary endpoint is to demonstrate non-inferior exposure of subcutaneous BRIUMVI compared to IV BRIUMVI at week 24 [2] Market Potential - The introduction of a subcutaneous formulation could significantly broaden the market opportunity for BRIUMVI, potentially increasing its adoption among patients who prefer self-administration [2] - The company anticipates that positive trial results could support regulatory approval by 2028 [2]