Dianthus Completes Enrollment in Phase 2 MaGic Trial for DNTH103

Dianthus Therapeutics, Inc., a clinical-stage biotechnology company dedicated to advancing the next generation of antibody complement therapeutics to treat severe autoimmune diseases, announced completion of enrollment in the phase 2 MaGic trial of DNTH103 in patients with generalized myasthenia gravis (gMG). DNTH103 is an investigational, clinical-stage, potent monoclonal antibody engineered to selectively target the classical pathway by inhibiting only the active form of the C1s protein. Initial top-line results from the MaGic trial are anticipated in September 2025.

MaGic is a global, randomized, double-blind, placebo-controlled phase 2 trial that enrolled 65 patients with acetylcholine receptor (AChR) antibody positive gMG, exceeding the enrollment target of 60 patients. The primary endpoint of the trial is safety and tolerability, and key secondary endpoints include myasthenia gravis activities of daily living scale (MG-ADL) and quantitative myasthenia gravis (QMG) score assessments.

“We are pleased to have reached this important milestone in the development of DNTH103 for gMG, which is well understood to be a classical pathway-driven disease,” said Marino Garcia, chief executive officer of Dianthus Therapeutics. “Latest estimates indicate that the gMG market in the US exceeds 100,000 patients, approximately 85% of whom have AChR autoantibody-driven disease, with growing first-line biologic use. Despite currently approved treatment options, a significant unmet need exists for patients seeking continuous symptom control, lower risk for infections, and more convenient dosing and administration, which we believe DNTH103 has the potential to address as a first-line therapy.”

DNTH103 is an investigational, clinical-stage, potent monoclonal antibody engineered to selectively target the classical pathway by inhibiting only the active form of the C1s protein, a clinically validated complement target. DNTH103 is designed to enable a more convenient subcutaneous, self-administered injection dosed as infrequently as once every two weeks. DNTH103 has the potential to be a best-in-class pipeline-in-a-product across a range of autoimmune disorders with high unmet need and is also being evaluated in the ongoing phase 3 CAPTIVATE trial in chronic inflammatory demyelinating polyneuropathy (CIDP) and the ongoing phase 2 MoMeNtum trial in Multifocal Motor Neuropathy (MMN). The company is on track for the interim responder analysis of the phase 3 CAPTIVATE trial in CIDP and top-line data from the phase 2 MoMeNtum trial in MMN in 2H’26.

The MaGic trial is a global, randomized, double-blind, placebo-controlled phase 2 study in patients with generalized Myasthenia Gravis who are acetylcholine receptor (AChR) antibody positive. Following an initial loading dose, DNTH103 will be administered every two weeks (Q2W) via subcutaneous (SC) injection. The SC treatment duration will initially be 12 weeks with a 52-week open-label extension. The primary endpoint of the study is safety and tolerability. Secondary endpoints include Myasthenia Gravis Activities of Daily Living Scale (MG-ADL) and quantitative myasthenia gravis (QMG) score assessments. Initial top-line results from this trial are anticipated in September 2025.

Generalized myasthenia gravis (gMG) is a chronic autoimmune disorder driven by the classical pathway that causes progressive muscle weakness. Over 100,000 people in the US are living with gMG and approximately 85% have AChR autoantibody-driven disease. Despite availability of current treatment options, a significant number of patients remain uncontrolled and are seeking better treatment options which may offer sustained efficacy, lower potential risk for infections, and convenient dosing and administration.

DNTH103 is an investigational, clinical-stage, potent monoclonal antibody engineered to selectively target the classical pathway by inhibiting only the active form of the C1s protein, a clinically validated complement target. DNTH103 is enhanced with YTE half-life extension technology designed to enable a more convenient subcutaneous, self-administered injection dosed as infrequently as once every two weeks. Additionally, selective inhibition of the classical complement pathway may lower patient risk of infection from encapsulated bacteria by preserving immune activity of the lectin and alternative pathways. As the classical pathway plays a significant role in disease pathology, DNTH103 has the potential to be a best-in-class pipeline-in-a-product across a range of autoimmune disorders with high unmet need. Dianthus is building a neuromuscular franchise with DNTH103 and anticipates reporting top-line data from the phase 2 MaGic trial in generalized Myasthenia Gravis in September 2025, the interim responder analysis of the phase 3 CAPTIVATE trial in chronic inflammatory demyelinating polyneuropathy in 2H’26, and top-line data from the phase 2 MoMeNtum trial in Multifocal Motor Neuropathy in 2H’26.

DNTH103 is an investigational agent that is not approved as a therapy in any indication in any jurisdiction worldwide.

Dianthus Therapeutics is a clinical-stage biotechnology company dedicated to designing and delivering novel, best-in-class monoclonal antibodies with improved selectivity and potency.

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