Remegen Reports P-III Trial Data of Telitacicept for Generalized Myasthenia Gravis (gMG)
Shots:
- Remegen has reported P-III trial data assessing Telitacicept (RC18; 240mg; n=57) vs PBO (n=57) in 114 chinese gMG pts, with baseline MG-ADL score ≥6 & QMG score ≥8; trial incl. 24wk. double-blind phase followed by an open-label phase. BLA is under the NMPA’s review, with decision expected in Q2’25
- Trial showed 98.1% vs 12% pts achieved ≥3-point MG-ADL reduction (-5.74 vs -0.91) as well as 87% vs 16% pts had ≥5-point QMG reduction (-8.66 vs -2.27) at 24wks., with improvements seen as early as 4wks., & continued till Wk. 24; Data was presented at AAN 2025
- Telitacicept is a novel fusion protein that acts as a dual inhibitor of BLyS & APRIL for the treatment of autoimmune diseases
Ref: Prnewswire | Image: Remegen
Related News:- RemeGen Reports the First Patient Enrollment in the P-III Study of Telitacicept to Treat Myasthenia Gravis
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