TG Therapeutics Announces Positive Topline Phase 1 Data for Subcutaneous BRIUMVI in Patients with Myasthenia Gravis and Initiation of Potential Registration Directed Randomized Phase 2 Trial
TG Therapeutics reported positive topline Phase 1 data for subcutaneous BRIUMVI in myasthenia gravis, showing 82% of patients achieved a Minimal Clinically Important Difference in MG-ADL scores with a mean improvement of 4.6 points at Week 24. The safety profile appeared consistent with the established intravenous formulation, supporting the continued development of the subcutaneous delivery method. Based on these results, the company initiated a potentially registration-directed Phase 2 trial evaluating BRIUMVI as a maintenance therapy following induction with efgartigimod in approximately 120 patients.
Key figures
- Drug Name
- BRIUMVI (ublituximab-xiiy)
- Phase Of Trial
- Phase 1 / Phase 2
- Mg adl mcid percent
- 82%
- Phase1 patient count
- 11
- Phase2 patient count
- approximately 120
- Mg adl improvement mean points
- 4.6
- Phase2 randomized period weeks
- 24
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