Classical Complement Pathway Inhibition
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Dianthus Therapeutics Highlights New Claseprubart Data Presented During 2025 AANEM Annual Meeting
Globenewswire· 2025-10-29 19:30
Core Insights - Dianthus Therapeutics presented positive data from the Phase 2 MaGic trial for claseprubart in generalized Myasthenia Gravis (gMG), indicating potential for 300mg/2mL Q4W dosing [1][3][4] - A Phase 3 gMG trial is planned to start in 2026, including QMG ≥10 screening criteria and two treatment arms: 300mg/2mL Q2W and 300mg/2mL Q4W, compared to placebo [1][4][7] - New preclinical data suggest efficacy benefits of upstream (active C1s) versus downstream (C5) complement inhibition [1][5] Company Overview - Dianthus Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing next-generation therapies for severe autoimmune diseases [3][9] - The company aims to build a neuromuscular franchise with claseprubart and plans to initiate a Phase 3 trial in gMG in 2026 [7][9] Clinical Data Highlights - The Phase 2 MaGic trial showed a robust decline in MG-ADL of -2.5 points at week 4 in the open-label extension, with a QMG score reduction of -3.2 points for placebo patients who received only two doses of claseprubart [5][6] - A subgroup analysis indicated a 3-point difference in MG-ADL treatment effect for patients with a QMG score ≥10 at baseline receiving 300mg/2mL Q2W [5][6] Future Outlook - The company is motivated to proceed to Phase 3 trials based on the impressive Phase 2 data and encouraging post hoc analyses [4][7] - Upcoming trials include the interim responder analysis of the Phase 3 CAPTIVATE trial in Chronic Inflammatory Demyelinating Polyneuropathy in the second half of 2026 and top-line data from the Phase 2 MoMeNtum trial in Multifocal Motor Neuropathy [7]