"Promising Results: Novartis' Atrasentan Phase III Study Shows Significant Proteinuria Reduction in IgA Nephropathy Patients"
Novartis has announced positive results from the interim analysis of its Phase III ALIGN study, which is evaluating the efficacy of atrasentan, an oral endothelin A receptor antagonist, in patients with IgA nephropathy (IgAN). The study met its primary endpoint, demonstrating superiority of atrasentan over placebo in reducing proteinuria (protein in urine) in patients with IgAN. The safety profile of atrasentan was consistent with previous data. Novartis plans to submit an application for accelerated approval based on these results, with the final readout of the study expected in the first quarter of 2026. IgAN is a progressive kidney disease that affects mostly young adults and is a major cause of chronic kidney disease and kidney failure worldwide. Novartis is developing three therapies for IgAN to address unmet needs in the treatment of the disease.