Argenx Halts Sjögren’s Disease Trial After Efficacy Failure
Argenx halted a late-stage Phase 3 trial of its drug efgartigimod after an interim analysis showed it was unlikely to meet its primary endpoint.
Shares of argenx fell more than 16% on Thursday after the Belgian biotech company halted the Phase 3 UNITY study of its drug efgartigimod for the treatment of Sjögren’s disease. An independent data monitoring committee recommended stopping the trial following an interim analysis, which concluded the drug was unlikely to meet its primary endpoint of measuring changes in overall disease activity at Week 48.
Despite the failure to show efficacy, the company reported that safety results remained consistent with the drug's established profile. Argenx plans to conduct a full data analysis after the study closes to inform future research directions.
Luc Truyen, the Chief Medical Officer at argenx, expressed disappointment over the outcome, stating that the result is most impactful for people living with Sjögren’s disease who are still waiting for treatments that fundamentally change the course of their disease. Efgartigimod remains approved for other conditions, including immune thrombocytopenia in Japan and generalized myasthenia gravis.
