Dianthus Therapeutics, Inc. (DNTH), a clinical-stage biotechnology firm, has announced that the U.S. Food and Drug Administration has granted clearance for its Phase 2 Investigational New Drug (IND) application, allowing the commencement of the MoMeNtum trial of DNTH103 in patients suffering from Multifocal Motor Neuropathy (MMN).
DNTH103 is a potent monoclonal antibody in the investigational and clinical stages, engineered to selectively target the classical pathway by inhibiting only the active form of the C1s protein, a clinically validated complement target.
The MoMeNtum trial is a global, randomized, double-blind, placebo-controlled Phase 2 study that aims to assess the safety, tolerability, and efficacy of DNTH103 in 36 patients with MMN. Initial top-line results from this Phase 2 trial are expected in the second half of fiscal 2026.
Participants in the trial will be randomly assigned to receive either a placebo or DNTH103, administered subcutaneously every two weeks. The initial treatment period is expected to last 17 weeks, followed by a 52-week open-label extension.
The primary endpoint of the trial is to evaluate safety and tolerability, while secondary endpoints include the time to IVIg retreatment, time to relapse, as well as assessments of muscle and grip strength.
Simrat Randhawa, Chief Medical Officer of Dianthus, stated, "Pre-clinical and clinical evidence supports the role of the classical pathway in the pathology observed in MMN. DNTH103 is a potent and highly selective inhibitor of active C1s, resulting in the inhibition of the classical pathway without affecting the alternative and lectin pathways that are crucial for infection defense."
It's important to note that DNTH103, still an investigational agent, has not been approved as a therapy for any indication in any jurisdiction globally. Dianthus further highlighted that DNTH103 holds the potential to be a best-in-class pipeline-in-a-product for a range of autoimmune disorders with significant unmet needs.
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