TG Therapeutics Sees 4.6-Point MG-ADL Improvement, Initiates Phase 2 Trial
TGTX•Subcutaneous BRIUMVI achieved a mean 4.6-point improvement in MG-ADL at Week 24, with 82% of patients (n=11) reaching at least a 2-point MCID in a Phase 1 myasthenia gravis trial. TG Therapeutics has launched a 120-patient, registration-directed Phase 2 study combining efgartigimod induction with BRIUMVI maintenance.
1. Phase 1 Subcutaneous BRIUMVI Efficacy
In the Phase 1 study of subcutaneous BRIUMVI, 11 AChR-antibody-positive myasthenia gravis patients (mean age 74, 73% male) had a mean baseline MG-ADL score of 8.24 and QMG score of 12.0. At Week 24, 82% achieved a ≥2-point MCID in MG-ADL with an average 4.6-point improvement and a median time to response of 30 days.
2. Phase 2 Trial Initiation and Sequential Design
TG Therapeutics has initiated a 120-patient Phase 2 trial in adult MG patients who first receive four weekly infusions of the FcRn inhibitor efgartigimod. Responders—defined by at least a 2-point MG-ADL improvement—will be randomized 1:1 to receive intravenous BRIUMVI or placebo over 24 weeks, with time to clinical worsening as the primary endpoint and a subsequent 72-week open-label extension.
3. Safety Profile and Development Milestones
Subcutaneous BRIUMVI was generally well tolerated, consistent with the established IV safety profile in multiple sclerosis. Full Phase 1 data are expected at an upcoming medical meeting, paving the way for a potential registration-directed pathway in myasthenia gravis.
