Argenx to continue development of efgartigimod subcutaneous

Argenx (ARGX) announced the decision to continue development of efgartigimod subcutaneous in the ongoing Phase 2/3 ALKIVIA study in adults with idiopathic inflammatory myopathies, following analysis of topline data from the Phase 2 portion of the study. ALKIVIA will continue to enroll patients across each of the three myositis subtypes in the study, including immune-mediated necrotizing myopathy, anti-synthetase syndrome, and dermatomyositis. The decision to continue clinical development of efgartigimod SC in each of the three myositis subtypes is supported by the efficacy and safety results from the Phase 2 portion of the seamless Phase 2/3 ALKIVIA study. Overall, the study met its primary endpoint, demonstrating a statistically significant treatment effect in mean total improvement score at Week 24, and showed improvement across all six core set measures of the TIS in favor of efgartigimod SC compared to placebo. The observed safety and tolerability profile was consistent to that demonstrated with other clinical trials.