Dianthus Therapeutics Completes Enrollment of Phase 2 MaGic Trial of DNTH103 in Generalized Myasthenia Gravis With Top-Line Results Expected in September

Core Insights - Dianthus Therapeutics has completed enrollment in the Phase 2 MaGic trial for DNTH103, targeting generalized Myasthenia Gravis (gMG) with a total of 65 patients enrolled, surpassing the initial target of 60 patients [2][3] - Initial top-line results from the MaGic trial are expected in September 2025, marking the first of three anticipated catalysts for DNTH103 by the end of 2026 [2][8] - DNTH103 is designed as a self-administered autoinjector, dosed once every two weeks, and aims to address significant unmet needs in the gMG market, which is estimated to exceed 100,000 patients in the U.S. [4][6] Company Overview - Dianthus Therapeutics is a clinical-stage biotechnology company focused on developing next-generation antibody complement therapeutics for severe autoimmune diseases [10] - The company is building a neuromuscular franchise with DNTH103, which is also being evaluated in ongoing trials for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Multifocal Motor Neuropathy (MMN) [4][8] - DNTH103 is a potent monoclonal antibody that selectively inhibits the classical pathway by targeting the active form of the C1s protein, potentially offering a best-in-class treatment option [7][8] Clinical Trial Details - The MaGic trial is a global, randomized, double-blind, placebo-controlled Phase 2 study focusing on safety and tolerability as the primary endpoint, with secondary endpoints including Myasthenia Gravis Activities of Daily Living Scale (MG-ADL) and Quantitative Myasthenia Gravis (QMG) score assessments [3][5] - Following an initial loading dose, DNTH103 will be administered via subcutaneous injection every two weeks, with a treatment duration of 12 weeks and a 52-week open-label extension [5][6] Market Context - The gMG market in the U.S. is characterized by a significant number of patients seeking better treatment options, with approximately 85% of gMG patients having AChR autoantibody-driven disease [4][6] - Despite existing treatment options, there remains a substantial unmet need for therapies that provide continuous symptom control, lower infection risk, and more convenient dosing [4][6]