Aug 17 (Reuters) – Belgian-Dutch immunology company argenxARGX.BR said its drug efgartigimod met the primary endpoint in a late-stage study treating adults with autoimmune myositis, showing significant improvement in disease activity.
The Phase 3 trial demonstrated rapid and sustained benefits over a placebo for two subtypes of the muscle-weakening disease, including one that currently has no approved therapies.
TRIAL RESULTS
• Patients treated with the drug had a 15.4-point greater improvement in mean total improvement score at 52 weeks compared to a placebo.
• The study is the first Phase 3 trial to show significant improvements in immune-mediated necrotizing myopathy, a disease subtype lacking approved options.
• While patients with the dermatomyositis subtype saw similar clinical improvements, the smaller cohort did not reach statistical significance, the company said.
• The drug was well-tolerated by patients, showing a safety profile consistent with prior trials, argenx said.
• “These are the first Phase 3 results to show that precision targeting of FcRn with efgartigimod can deliver meaningful benefit in this disease,” Chief Medical Officer Luc Truyen said.
(Reporting by Lucie Barbier; Editing by Matt Scuffham)
