BRUSSELS (dpa-AFX) - argenx SE (ARGX), an immunology company, on Monday announced positive topline results from the Phase 3 ALKIVIA study evaluating VYVGART Hytrulo in adults with autoimmune myositis.
The study met its primary endpoint, with patients treated with VYVGART Hytrulo demonstrating a statistically significant and clinically meaningful 15.4-point greater improvement in mean Total Improvement Score (TIS) at Week 52 versus placebo in the combined immune-mediated necrotizing myopathy (IMNM) and dermatomyositis (DM) population.
Patient improvements were observed early and sustained throughout the study, with a consistent treatment effect across both IMNM and DM patients.
VYVGART Hytrulo was well tolerated in the study, with the observed safety profile consistent with prior studies and the known safety profile of VYVGART.
The company said ALKIVIA is the first Phase 3 study to demonstrate statistically significant and clinically meaningful improvements in disease activity in IMNM, a subtype of autoimmune myositis for which there is currently no approved therapy.
On Friday, argenx shares closed down 0.66% at $851.29 in the regular hours on the Nasdaq. But in the overnight trading the stock was rising nearly 9%.
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