Dianthus Therapeutics Announces Positive Data for Claseprubart (DNTH103) from the Phase 2 MaGic Trial in Generalized Myasthenia Gravis, Supporting Its Potential Best-In-Class Profile

Core Insights - Dianthus Therapeutics announced positive top-line data from the Phase 2 MaGic trial for claseprubart, demonstrating significant efficacy and safety in treating generalized Myasthenia Gravis (gMG) [1][2][4] Efficacy Results - Claseprubart at both 300mg and 600mg doses showed statistically significant and clinically meaningful improvements in Myasthenia Gravis Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) scores at Week 13, with improvements observed as early as Week 1 [1][4][12] - The 300mg Q2W dose achieved a mean improvement of 4.6 points in MG-ADL (placebo-adjusted: 1.8 points, P=0.0113) and 4.4 points in QMG (placebo-adjusted: 2.4 points, P=0.0144) at Week 13 [10][12] - The 600mg Q2W dose achieved a mean improvement of 5.4 points in MG-ADL (placebo-adjusted: 2.6 points, P=0.0006) and 4.5 points in QMG (placebo-adjusted: 2.5 points, P=0.0111) at Week 13 [10][12] Safety Profile - Claseprubart demonstrated a favorable safety profile with no drug-related serious adverse events or discontinuations, and no serious bacterial infections were reported [5][21] - Injection site reactions were infrequent and mild, indicating good tolerability [21] Future Developments - The Phase 3 trial for claseprubart in gMG is anticipated to begin in 2026, with plans for an end-of-Phase 2 meeting with the FDA to discuss trial design [15][17] - The company is also preparing for interim analyses from other ongoing trials in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Multifocal Motor Neuropathy (MMN) in the second half of 2026 [15][17] Company Overview - Dianthus Therapeutics is focused on developing next-generation antibody complement therapeutics for severe autoimmune diseases, with claseprubart being a key product in their pipeline [20]