Dianthus Therapeutics Gets FDA Clearance for DNTH103 Phase 2 Trial

By Chris Wack

Dianthus Therapeutics said that the U.S. Food and Drug Administration cleared its Phase 2 Investigational New Drug application for a trial of DNTH103 in patients with multifocal motor neuropathy.

The biotechnology company said Wednesday the trial is a study designed to evaluate the safety, tolerability, and efficacy of DNTH103 in 36 patients with multifocal motor neuropathy. The primary endpoint of the study is safety and tolerability with secondary endpoints including time to IVIg retreatment, time to relapse, and assessments of muscle and grip strength.

DNTH103 is a treatment for multifocal motor neuropathy, a disease affecting the body's motor nerves.

Initial top-line results from this trial are anticipated to be available in the second half of 2026.

Write to Chris Wack at [e-mail]

(END) Dow Jones Newswires

06-12-24 0801ET