Grandbrothers/iStock Editorial via Getty Images Dianthus Therapeutics ( NASDAQ: DNTH ) announced Wednesday that the U.S. FDA cleared its investigational new drug (IND) application, allowing it to start a Phase 2 trial for its lead asset DNTH103 in multifocal motor neuropathy (MMN), a rare neuromuscular disorder.
The MoMeNtum trial is designed to enroll 36 patients with MMN. According to the company, they will be subject to an initial treatment duration of 17 weeks and a subsequent 52-week open-label extension. The globally conducted trial is set to generate topline data in H2 2026.
DNTH103, which targets C1s protein in the complement pathway, is a subcutaneous, self-administered injection as opposed to intravenous or subcutaneous infusions used as MMN therapies in current medical practice. “Treating MMN with an active C1s inhibitor, like DNTH103, has the potential to transform the lives of these patients,” said Hans Katzberg, an Associate Professor of Neurology at the University of Toronto. More on Dianthus Therapeutics H.
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