TG Therapeutics presents updated data from ENHANCE Phase 3b trial of BRIUMVI

TG Therapeutics presented updated data from the ENHANCE Phase 3b trial evaluating BRIUMVI in patients with relapsing forms of multiple sclerosis, at the 2024 European Committee for Treatment and Research in Multiple Sclerosis annual meeting. Michael Weiss, CEO stated, “We are excited to present an update from our ENHANCE Phase 3b study which is evaluating potential optimized dosing regimens for BRIUMVI. This study initially focused on patients switching from a prior anti-CD20 therapy in a B-cell depleted state, and we believe the data emerging from this study continues to support that these patients can successfully make that transition conveniently and safely without the initial 150 mg, 4-hour BRIUMVI infusion.Separately, we are excited to present, for the first time, data exploring even faster infusions of BRIUMVI, from 1 hour down to 30 minutes for full doses starting at week 24. Notably, these rapid infusions are being accomplished with non-drowsy pre-medications and no required post-infusion observation time as per the protocol, consistent with the BRIUMVI prescribing information. We look forward to continuing to find ways to improve patient tolerability and convenience and working with regulatory agencies to transition these efforts into label-enabling studies.” DATA HIGHLIGHTS: Poster Presentation: Efficacy and Tolerability of BRIUMVI after Transitioning from a Different Disease-Modifying Therapy: Updates from the ENHANCE Study: ENHANCE is a multi-center, open-label, 48-week study in participants with relapsing forms of multiple sclerosis designed to evaluate optimized dosing regimens for BRIUMVI with two primary objectives: Evaluating the elimination of the initial 150 mg BRIUMVI infusion in patients who are B-cell depleted; Exploring shorter infusion durations for the full 450 mg BRIUMVI infusions. Data continue to support that 450 mg of BRIUMVI may be safely administered in 1 hour as an initial infusion for participants who are B-cell depleted, with 97% of infusions being completed without interruption or slowing. 12 patients received 450 mg BRIUMVI infusions in 30 minutes at week 24, with all infusions completed without interruption or slowing, and infusions related reactions were limited to Grade 1.