TG Therapeutics has completed enrolment in its Phase III trial investigating subcutaneous Briumvi (ublituximab-xiiy) in adults with relapsing multiple sclerosis (RMS).
Currently approved in the US and selected regions outside the US, Briumvi is now given as a one-hour intravenous (IV) infusion biannually following the initial dose.
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The randomised, non-inferiority, parallel-group, multi-centre, open-label trial will compare the pharmacodynamics, pharmacokinetics, radiological, safety, and clinical outcomes of subcutaneous Briumvi with IV Briumvi among adults with RMS.
Participants have been randomly assigned to receive either an every eight-week regimen or an every 12-week regimen of subcutaneous Briumvi, or the approved IV dosing schedule.
The trial’s primary endpoint is to demonstrate non-inferior drug exposure for subcutaneous Briumvi compared to IV administration, measured as area under the curve (AUC) at week 24.
Briumvi is a monoclonal antibody that targets a specific epitope on cluster of differentiation 20 (CD20)-expressing B-cells.
It is approved in the US for adults with RMS, and in the European Union and the UK for adults with active disease, as defined by clinical or imaging data.
RMS is a chronic demyelinating central nervous system disorder, comprising relapsing-remitting MS and secondary progressive MS with ongoing relapses.
TG Therapeutics chairman and CEO Michael Weiss said: “The completion of enrolment in our Phase III subcutaneous Briumvi trial represents a significant step forward for our development programme and underscores our continued execution across the Briumvi franchise.
“We thank the investigators, site personnel, and, importantly, the study participants who are living with MS who made this milestone possible. We believe subcutaneous Briumvi has the potential to significantly broaden our reach by offering patients greater flexibility, including a self-administered at-home option, and we look forward to sharing topline data from this trial around year-end 2026 or early 2027.”
