Dianthus Therapeutics宣布Claseprubart第2阶段结果支持每两周一次方便的自皮下自动注射器剂量用于gMG

2025-09-08 19:08

Claseprubart 300mg and 600mg Q2W doses both achieved statistically significant and clinically meaningful improvements in Myasthenia Gravis Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) scores at Week 13
Claseprubart demonstrated a rapid and sustained onset of action, with both doses achieving statistically significant improvements in MG-ADL and QMG scores at Week 1
Claseprubart 300mg Q2W dose was also statistically significant and clinically meaningful across other key efficacy endpoints, including Minimal Symptom Expression (MSE), Myasthenia Gravis Composite (MGC) Score and the Myasthenia Gravis Quality of Life Scale (MG-QoL-15r)
Both 300mg and 600mg doses of claseprubart were comparable across key efficacy endpoints, supporting its target product profile of a single, convenient 300mg/2mL self-administered, subcutaneous autoinjector dosed once every two weeks
Claseprubart had a favorable safety profile with no related serious infections, clinical symptoms of emergent autoimmune disease, or drug-related serious adverse events or discontinuations, supporting its target product profile of no Boxed Warning or REMS for meningococcal infections
Phase 3 gMG trial evaluating 300mg/2mL Q2W and Q4W vs. placebo anticipated to initiate in 2026
Investor conference call and webcast to be held today, September 8, 2025 at 8:00 a.m. ET