Novartis today announced positive topline results from the interim analysis of the ongoing pivotal Phase 3 ALIGN study of atrasentan, an oral endothelin A receptor antagonist (ERA), in patients with IgAnephropathy (IgAN).
The study met its primary efficacy endpoint at the 36-week interim analysis, with atrasentan demonstrating superiority versus placebo with a clinically meaningful and highly statistically significant reduction in proteinuria (protein in urine) in patients with IgAN receiving supportive care (maximally tolerated and stable dose of a renin-angiotensin system [RAS] inhibitor).
In the study, the safety profile of atrasentan was consistent with previously reported data from the Phase 2 AFFINITY study IgAN cohort. Based on the results from this interim proteinuria endpoint analysis, Novartis plans to submit an application in 2024 for possible accelerated approval in the US.
“These positive topline Phase 3 data showcase the potential of atrasentan to improve outcomes for patients with IgAN by demonstrating clinically meaningful proteinuria reduction,” said Shreeram Aradhye, M.D., President, Development and Chief Medical Officer, Novartis. “Along with investigational iptacopan, which recently also showed positive topline Phase 3 results, and investigational zigakibart, our development portfolio of three highly differentiated late-stage therapies in IgAN has the potential to provide much-needed treatment options for people living with this debilitating disease.”
👉 Novartis investigational atrasentan Phase III study demonstrates clinically meaningful and highly statistically significant proteinuria reduction in patients with IgA nephropathy (IgAN) | Novartis
