New York, Waltham, Mass. — September 8, 2025. — Leads & Copy — Dianthus Therapeutics, Inc. (Nasdaq: DNTH) announced positive top-line data from its Phase 2 MaGic trial. The trial evaluated the safety and efficacy of claseprubart (DNTH103) in adults with acetylcholine receptor antibody positive (AChR+) generalized Myasthenia Gravis (gMG).
The results from MaGic mark a significant milestone for Dianthus and are an important step forward for people living with gMG, said Marino Garcia, President and Chief Executive Officer of Dianthus Therapeutics.
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. The trial also demonstrated a rapid and sustained onset of action, with both doses achieving statistically significant improvements in MG-ADL and QMG scores at Week 1.
The 300mg Q2W dose was 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 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. A Phase 3 gMG trial evaluating 300mg/2mL Q2W and Q4W vs. placebo is anticipated to initiate in 2026.
Jennifer Davis Ruff, Dianthus Therapeutics, jdavisruff@dianthustx.com
Source: Dianthus Therapeutics
