Dianthus announces data from Phase 2 MaGic trial of claseprubart

Dianthus (DNTH) Therapeutics announced top-line data from the Phase 2 MaGic trial evaluating the safety and efficacy of claseprubart in adults with acetylcholine receptor antibody positive generalized Myasthenia Gravis. Claseprubart 300mg and 600mg demonstrated rapid, statistically significant and clinically meaningful improvements over placebo as measured by both MG-ADL and QMG, including at Week 1 and at Week 13. The claseprubart 300mg Q2W dose was also statistically significant and clinically meaningful across other key efficacy endpoints, including Minimal Symptom Expression, Myasthenia Gravis Composite Score and the Myasthenia Gravis Quality of Life Scale. Claseprubart was generally well tolerated with no drug-related Serious Adverse Events or discontinuations due to any related adverse event. Claseprubart had a favorable clinical safety profile comparable to placebo with no treatment-related serious bacterial infections and no clinical symptoms of emergent autoimmune disorders observed. “Based on the comparable efficacy data demonstrated in MaGic by the 300mg and 600mg Q2W doses, as well as encouraging early data from the open-label extension, we are planning for an end-of-Phase 2 meeting with the FDA to align on the proposed design of a Phase 3 trial for claseprubart in Myasthenia Gravis that investigates both 300mg Q2W and 300mg Q4W doses vs. placebo,” said Marino Garcia, President and Chief Executive Officer of Dianthus Therapeutics. “2026 will be a catalyst-rich year, with the initiation of the Phase 3 gMG trial followed by results from the interim responder analysis of the Phase 3 CAPTIVATE trial in Chronic Inflammatory Demyelinating Polyneuropathy and top-line results from the Phase 2 MoMeNtum trial in Multifocal Motor Neuropathy, both in 2H’26.”