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(RTTNews) - Dianthus Therapeutics, Inc. (DNTH), a clinical-stage biotechnology company, announced Wednesday the U.S. Food and Drug Administration clearance for its Phase 2 Investigational New Drug or IND application to initiate the MoMeNtum trial of DNTH103 in patients with Multifocal Motor Neuropathy.

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.

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 Multifocal Motor Neuropathy or MMN.

Initial top-line results from the Phase 2 trial in MMN are anticipated in the second half of fiscal 2026.

In the trial, patients will be randomized to receive placebo or DNTH103 administered subcutaneously every two weeks. The initial treatment duration is expected to be 17 weeks followed by a 52-week open label extension.

The trial's primary endpoint is safety and tolerability, while secondary endpoints include time to IVIg retreatment, time to relapse, and assessments of muscle and grip strength.

Simrat Randhawa, Chief Medical Officer of Dianthus, said, "Pre-clinical and clinical evidence support the classical pathway's role in the pathology seen in MMN. 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."

DNTH103, which is an investigational agent, is not approved as a therapy in any indication in any jurisdiction worldwide.

The company noted that DNTH103 has the potential to be a best-in-class pipeline-in-a-product across a range of autoimmune disorders with high unmet need.

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