MedPath

DNTH-103

Generic Name
DNTH-103

Dianthus Therapeutics Completes Enrollment in Phase 2 MaGic Trial for Generalized Myasthenia Gravis Treatment

• Dianthus Therapeutics has successfully enrolled 65 patients in its Phase 2 MaGic trial of DNTH103 for generalized Myasthenia Gravis, exceeding the target of 60 patients with top-line results expected in September 2025. • DNTH103 is a monoclonal antibody designed to selectively inhibit the classical complement pathway by targeting the C1s protein, potentially offering patients a convenient self-administered subcutaneous injection dosed once every two weeks. • The company is building a neuromuscular franchise with DNTH103, which is also being evaluated in Phase 3 trials for Chronic Inflammatory Demyelinating Polyneuropathy and Phase 2 trials for Multifocal Motor Neuropathy, with results expected in the second half of 2026.

Complement Inhibitors Show Promise in Diverse Clinical Trials

• The complement inhibitors market is experiencing growth due to increased understanding of the complement system's role in rare and chronic diseases. • Over 40 companies are actively developing more than 50 complement inhibitor therapies, targeting conditions like PNH, aHUS and Guillain-Barré syndrome. • Clinical trials are underway for novel inhibitors like Gefurulimab, ANX005 and DNTH103, showing potential in myasthenia gravis and multifocal motor neuropathy. • Recent FDA clearances and orphan drug designations highlight the increasing regulatory support for complement-targeted therapies, fostering innovation.

Hesperos' Human-on-a-Chip Technology Supports Phase II Trial of DNTH103 for Generalized Myasthenia Gravis

• Hesperos' Human-on-a-Chip technology supported Dianthus Therapeutics' Investigational New Drug submission for DNTH103, a monoclonal antibody, to the FDA. • DNTH103 is currently in a Phase II clinical trial for the treatment of generalized myasthenia gravis (gMG), a chronic autoimmune disorder. • Preclinical data using Hesperos' neuromuscular junction model demonstrated DNTH103 improved nerve cell transmission and decreased muscle fatigue in gMG patient serum. • The Human-on-a-Chip platform offers physiologically relevant functional readouts, potentially predicting therapeutic profiles and accelerating drug development.
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