Business
Dianthus Therapeutics Highlights Recent Business Achievements and Reports Q3 Financial Results
Initiation of a single, two-part, pivotal Phase 3 trial of DNTH103 in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) anticipated by YE’24 Phase 2
About this update from Dianthus Therapeutics, Inc.
[{"type":"text","content":"Initiation of a single, two-part, pivotal Phase 3 trial of DNTH103 in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) anticipated by YE’24 Phase 2 MaGic trial of DNTH103 in generalized Myasthenia Gravis (gMG) ongoing; top-line results anticipated in 2H’25 Phase 2 MoMeNtum trial of DNTH103 in Multifocal Motor Neuropathy (MMN) ongoing; top-line results anticipated in 2H’26 Approximately $343 million of cash provides runway into 2H’27 NEW YORK and WALTHAM, Mass., Nov. 07, 2024 (GLOBE NEWSWIRE) -- 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 reported financial results for the third quarter ending September 30, 2024 and provided an update on recent business achievements. “We are excited to expand DNTH103 beyond gMG and MMN into CIDP before year end. Like gMG and MMN, CIDP has significant unmet needs where a best-in-class, potent classical pathway inhibitor can potentially make a meaningful difference in the lives of patients. We believe this single, two-part, pivotal Phase 3 trial will support BLA filing in adult patients with CIDP and we anticipate initiating the trial by year-end 2024,” said Marino Garcia, Chief Executive Officer of Dianthus Therapeutics. “We continue to be confident in the pipeline-in-a-product potential of DNTH103 across multiple autoimmune diseases, supported by our proof-of-concept in vitro data most recently presented at AANEM and ICNMD and competitor clinical data that further validate targeting the classical pathway and active C1s.” DNTH103 Clinical Development 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. DNTH103 has the potential to be a best-in-class pipeline-in-a-product across a range of autoimmune disorders with high unmet need. Generalized Myasthenia Gravis (gMG) Phase 2 MaGic gMG trial ongoing: The MaGic trial is a global, randomized, double-blind, placebo-controlled Phase 2 ...