Dianthus Therapeutics Announces Initiation of Phase 2 MaGic Trial of DNTH103 In Generalized Myasthenia Gravis (gMG)
2024-02-27
临床2期临床申请
Top-line results from gMG MaGic trial anticipated in 2H 2025
Building a neuromuscular franchise with DNTH103 through additional planned Phase 2 trials in Multifocal Motor Neuropathy (MMN) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
DNTH103 is a potential best-in-class, potent classical pathway inhibitor planned for self-administration as a low volume, subcutaneous injection once every two weeks
Feb. 26, 2024 -- Dianthus Therapeutics, Inc. (Nasdaq: DNTH), a clinical-stage biotechnology company dedicated to advancing the next generation of antibody complement therapeutics to treat severe autoimmune diseases, today announced the initiation of the Phase 2 MaGic trial of DNTH103 in patients with generalized Myasthenia Gravis. The initiation follows U.S. Food and Drug Administration (FDA) clearance of the Phase 2 Investigational New Drug (IND) application for DNTH103. Top-line results from this trial are anticipated in the second half of 2025.
“Following our encouraging Phase 1 data demonstrating a 60-day half-life and potent, specific classical pathway inhibition, we are excited to rapidly advance DNTH103, our investigational active C1s inhibitor, into a Phase 2 study in generalized Myasthenia Gravis,” said Simrat Randhawa, M.D., Chief Medical Officer of Dianthus Therapeutics. “DNTH103 provides a unique approach to complement inhibition in gMG, which could result in a more convenient and safer alternative for patients versus current options.”
The MaGic trial is a global, randomized, double-blind, placebo-controlled Phase 2 study in up to 60 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 (S.C.) injection. The S.C. 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 to be available in the second half of 2025.
“For patients with AchR-positive gMG, inappropriate activation of the complement classical pathway is a major driver of disease pathology and therefore patient symptoms,” said Mazen M. Dimachkie, M.D., Professor of Neurology and Director of Neuromuscular Division at the University of Kansas Medical Center. “I am excited to collaborate with Dianthus to evaluate this investigational, highly specific classical pathway inhibitor that could fill the need for a more convenient and safe complement inhibitor for my gMG patients.”
About DNTH103
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 has initiated a Phase 2 trial in generalized Myasthenia Gravis and plans to initiate additional Phase 2 trials in other neuromuscular indications, including Multifocal Motor Neuropathy and Chronic Inflammatory Demyelinating Polyneuropathy, in 2024.
About Dianthus Therapeutics
Dianthus Therapeutics is a clinical-stage biotechnology company dedicated to designing and delivering novel, best-in-class monoclonal antibodies with improved selectivity and potency. Based in New York City and Waltham, Mass., Dianthus is comprised of an experienced team of biotech and pharma executives who are leading the development of next-generation antibody complement therapeutics, aiming to deliver transformative medicines for people living with severe autoimmune and inflammatory diseases.
Dianthus has initiated a Phase 2 trial of DNTH103, a potential best-in-class active C1s inhibitor, in generalized Myasthenia Gravis and plans to initiate additional Phase 2 trials in other neuromuscular indications, including Multifocal Motor Neuropathy and Chronic Inflammatory Demyelinating Polyneuropathy, in 2024.
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