TG Therapeutics Reports Positive Phase 1 Results for BRIUMVI in Myasthenia Gravis and Launches Phase 2 Trial
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
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TG Therapeutics announced positive Phase 1 results for subcutaneous BRIUMVI in treating myasthenia gravis, with 82% of participants achieving a significant improvement. A Phase 2 trial has begun to evaluate BRIUMVI as a maintenance therapy following efgartigimod induction.
- 0182% of patients achieved a Minimal Clinically Important Difference (MCID) in MG-ADL after treatment with subcutaneous BRIUMVI.
- 02The Phase 1 study involved 11 patients, showing a mean improvement of 4.6 points in MG-ADL after 24 weeks.
- 03The Phase 2 trial aims to enroll about 120 patients to assess BRIUMVI's efficacy as a maintenance therapy after efgartigimod.
- 04The primary endpoint of the Phase 2 trial is the time to clinical worsening, defined as a ≥2-point increase in MG-ADL score.
- 05BRIUMVI is a monoclonal antibody targeting CD20-expressing B-cells, currently approved for multiple sclerosis treatment.
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TG Therapeutics, Inc. has announced promising topline results from a Phase 1 study of subcutaneous BRIUMVI (ublituximab-xiiy) for patients with myasthenia gravis (MG). In the study involving 11 patients, 82% achieved a Minimal Clinically Important Difference (MCID) in the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale, with an average improvement of 4.6 points observed at 24 weeks. Following these results, the company has initiated a Phase 2 clinical trial to evaluate BRIUMVI as a maintenance therapy after induction with the FcRn inhibitor efgartigimod. This trial will enroll approximately 120 patients who will first receive efgartigimod before being randomized to receive either BRIUMVI or placebo. The primary endpoint is the time to clinical worsening, aiming to establish a new treatment paradigm for MG that combines rapid symptom control with sustained disease modification. BRIUMVI is already approved for use in treating relapsing forms of multiple sclerosis, and these developments may expand its therapeutic applications.
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The development of BRIUMVI as a treatment for myasthenia gravis could provide patients with a more effective and less burdensome therapy, improving their quality of life.
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