Phase 2 MaGic Trial for DNTH103 in gMG Launched by Dianthus

Dianthus Therapeutics, a clinical-stage biotechnology firm, has initiated a Phase 2 clinical trial for DNTH103, an investigational drug for generalized Myasthenia Gravis (gMG). The FDA has cleared the IND application for the drug, and the trial's primary focus is on safety and tolerability, with secondary endpoints involving activity and quality of life assessments. The study will involve up to 60 patients and is expected to deliver initial results in the second half of 2025.

DNTH103 is a monoclonal antibody designed to inhibit the active form of the C1s protein, a key component in the classical complement pathway, which is implicated in gMG. The drug is enhanced with technology that extends its half-life, allowing for less frequent subcutaneous injections. It is anticipated to be a more convenient and safer alternative to existing treatments.

Simrat Randhawa, the Chief Medical Officer of Dianthus Therapeutics, expressed excitement about advancing DNTH103 into the Phase 2 study following positive Phase 1 data. Mazen M. Dimachkie, a neurology professor, highlighted the importance of addressing the complement classical pathway in gMG and the potential of DNTH103 to meet patient needs.

DNTH103's development is part of Dianthus's broader strategy to build a neuromuscular franchise. The company plans to expand its trials to include other neuromuscular conditions such as Multifocal Motor Neuropathy and Chronic Inflammatory Demyelinating Polyneuropathy in 2024.

Dianthus Therapeutics is based in New York City and Waltham, Massachusetts, and is committed to developing next-generation antibody complement therapeutics to treat severe autoimmune diseases. The company's experienced team is focused on creating transformative medicines for individuals with severe autoimmune and inflammatory conditions.