Dianthus Therapeutics Announces FDA Clearance to Initiate Phase 2 Trial of DNTH103 in Multifocal Motor Neuropathy (MMN)
临床2期临床申请
Top-line results from Phase 2 MoMeNtum trial in Multifocal Motor Neuropathy anticipated in 2H 2026
Building a neuromuscular franchise with DNTH103 following the initiation of the Phase 2 MaGic trial in generalized Myasthenia Gravis (gMG) in 1Q’24 and planned initiation of a Phase 2 trial in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in 2H’24
Recently disclosed head-to-head affinity and PD potency data reinforce DNTH103 is a highly potent, potential best-in-class active C1s inhibitor designed for self-administration in a low-volume, subcutaneous autoinjector once every two weeks
June 12, 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 U.S. Food and Drug Administration (FDA) clearance of its Phase 2 Investigational New Drug (IND) application for the MoMeNtum trial of DNTH103 in patients with Multifocal Motor Neuropathy (MMN).
“Pre-clinical and clinical evidence support the classical pathway’s role in the pathology seen in MMN,” said Simrat Randhawa, MD, Chief Medical Officer of Dianthus Therapeutics. “DNTH103 is a potent and highly selective inhibitor of active C1s resulting in classical pathway inhibition, without inhibiting the alternative and lectin pathways that are critical in the defense against infection. The Dianthus medical team and our MMN steering committee are excited to investigate the potential benefits DNTH103 may bring to MMN patients.”
The MoMeNtum trial is a global, randomized, double-blind, placebo-controlled Phase 2 study designed to evaluate the safety, tolerability, and efficacy of DNTH103 in 36 patients with MMN. Following determination of Ig dependency and responsiveness, patients will be randomized to receive placebo or DNTH103 administered subcutaneously (S.C.) every two weeks (Q2W). The initial S.C. treatment duration is expected to be 17 weeks followed by a 52-week open label extension. The primary endpoint of this study is safety and tolerability. Secondary endpoints include time to IVIg retreatment, time to relapse, and assessments of muscle and grip strength. Initial top-line results from this trial are anticipated to be available in the second half of 2026.
“There is a significant unmet medical need for a targeted biologic to treat patients living with MMN,” said Hans Katzberg, MD, MSc, FRCPC, Associate Professor of Neurology, University of Toronto, Prosserman Centre of Neuromuscular Disease. “Today, treatments for MMN are limited to intravenous or subcutaneous infusions of Ig, which can be both inconvenient for patients and difficult to tolerate. Treating MMN with an active C1s inhibitor, like DNTH103, has the potential to transform the lives of these 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 is building a neuromuscular franchise with DNTH103 following the initiation of the Phase 2 MaGic trial in generalized Myasthenia Gravis in 1Q’24, regulatory clearance for Multifocal Motor Neuropathy in 2Q’24, and planned initiation of a Phase 2 trial in Chronic Inflammatory Demyelinating Polyneuropathy in 2H’24.
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.
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