Novartis presents results from interim analysis of Phase III ALIGN study

Novartis today presented results from a pre-specified interim analysis of the Phase III ALIGN study of atrasentan, an investigational oral selective endothelin A receptor antagonist, in patients with IgA nephropathy. Patients treated with atrasentan, in addition to supportive care, achieved a 36.1% reduction in proteinuria at 36 weeks when compared to placebo on top of supportive care. The results were presented during a late-breaking clinical trials session at the European Renal Association Congress. The study also showed atrasentan has a favorable safety profile consistent with previously reported data. Proteinuria reduction is a recognized surrogate marker correlating with delaying progression to kidney failure and has been used as an endpoint in IgAN clinical trials to support accelerated regulatory approvals.U.S. FDA submission for atrasentan in IgAN is on track for the first half of 2024. The ALIGN study continues in a blinded manner, and therefore only limited interim analysis results can be presented. The final analysis, including the key secondary endpoint of change from baseline in estimated glomerular filtration rate at 136 weeks, and the results in participants receiving a sodium-glucose co-transporter-2 inhibitor as background care in an exploratory cohort, is expected in 2026.