Dianthus Therapeutics Gets FDA Nod for Phase 2 Trial of DNTH103 in MMN

Dianthus Therapeutics, Inc., a clinical-stage biotech firm focused on innovating antibody complement therapeutics for severe autoimmune diseases, has announced that the U.S. Food and Drug Administration (FDA) has cleared its Phase 2 Investigational New Drug (IND) application for the MoMeNtum trial. This trial will investigate DNTH103 in patients with Multifocal Motor Neuropathy (MMN).

According to Simrat Randhawa, MD, the Chief Medical Officer at Dianthus Therapeutics, DNTH103 is a highly selective inhibitor of active C1s, which is part of the classical complement pathway. This pathway is often implicated in the pathology of MMN. DNTH103 inhibits this pathway without affecting the alternative and lectin pathways that are essential for infection defense. The forthcoming MoMeNtum trial will be a global, randomized, double-blind, placebo-controlled Phase 2 study. It aims to assess the safety, tolerability, and efficacy of DNTH103 in 36 MMN patients. Participants will initially undergo treatment for 17 weeks, followed by a 52-week open label extension. The main goal is to evaluate safety and tolerability, with secondary goals including time to IVIg retreatment, time to relapse, and muscle and grip strength assessments. The first top-line results from this trial are anticipated in the second half of 2026.

Dr. Hans Katzberg, Associate Professor of Neurology at the University of Toronto, emphasized the significant unmet medical need for targeted MMN treatments. Current treatments are limited to intravenous or subcutaneous infusions of immunoglobulins (Ig), which may be inconvenient and difficult to tolerate. Katzberg highlighted that DNTH103, as an active C1s inhibitor, could potentially transform the treatment landscape for MMN patients.

DNTH103 is a potent investigational monoclonal antibody engineered to selectively inhibit the active form of C1s within the classical complement pathway. It incorporates YTE half-life extension technology, which allows for a more convenient subcutaneous, self-administered injection every two weeks. By specifically targeting the classical complement pathway and preserving the lectin and alternative pathways, DNTH103 may reduce the risk of infections from encapsulated bacteria. The drug has the potential to be a best-in-class therapeutic across various autoimmune disorders with high unmet needs.

Dianthus Therapeutics is also building a broader neuromuscular franchise around DNTH103. Following the initiation of the Phase 2 MaGic trial in generalized Myasthenia Gravis (gMG) in the first quarter of 2024, the company plans to start a Phase 2 trial for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in the second half of 2024. These trials will further investigate DNTH103’s potential across a range of severe autoimmune conditions.

Based in New York City and Waltham, Massachusetts, Dianthus Therapeutics consists of a team of experienced biotech and pharmaceutical executives. The company is dedicated to developing next-generation antibody complement therapeutics to deliver transformative treatments for people living with severe autoimmune and inflammatory diseases.