Dianthus Therapeutics has received authorisation from the US Food and Drug Administration (FDA) to begin a new trial with its candidate DNTH103, as the company looks to lay out a neuromuscular franchise with the drug.

The FDA gave clearance to a Phase II investigational new drug (IND) application to study DNTH103 in the treatment of multi-focal motor neuropathy (MMN).

The global, randomised, double-blind, placebo-controlled trial, named MoMeNtum, will assess the safety, tolerability, and efficacy of DNTH103 in 36 patients with MMN – a disease that affects the motor nerves of the body. Patients will either receive Dianthus’ drug or a placebo subcutaneously administered every two weeks.

Dianthus expects the initial treatment window to last 17 weeks followed by a year-long open-label extension.

The primary endpoint of safety and tolerability is accompanied by secondary endpoints of time to IVIg [intravenous immunoglobulin] retreatment, time to relapse, and muscle and grip strength assessments.

University of Toronto’s associate neurology professor Hans Katzberg said: “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.”

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Initial top-line results are slated for the second half of 2026, according to the US biotech.

DNTH103 is a long-acting monoclonal antibody that inhibits the active form of C1s, a protein involved in a pathway that promotes inflammation. Usually used to clear microbes and damaged cells, the pathway – called the classical complement system – is suggested to play a role in some autoimmune diseases.

Dianthus says DNTH103 “holds the potential to be a pipeline in a product”, citing potential indications in generalised myasthenia gravis (gMG), chronic inflammatory demyelinating polyneuropathy, as well as MMN.

The biotech currently has a Phase II trial underway investigating the drug for the treatment of gMG. Top-line data from this trial is expected in the second half of 2025.

In May 2023, Dianthus signed a merger agreement with Magenta Therapeutics in an all-stock deal that saw the new entity keep the Dianthus Therapeutics brand name.