Novartis has reported positive results from the interim analysis of its pivotal Phase III ALIGN study, which assessed the effectiveness of atrasentan, an oral endothelin A receptor antagonist (ERA), in treating IgA nephropathy (IgAN). The interim analysis, conducted at 36 weeks, revealed that atrasentan was superior to placebo in reducing proteinuria (the presence of excess protein in the urine) among IgAN patients receiving supportive care, with a clinically significant and statistically significant proteinuria reduction.
IgAN is a progressive kidney disease that predominantly affects young adults and is a major contributor to chronic kidney disease and kidney failure worldwide. Up to 30% of individuals with IgAN who have persistently high levels of proteinuria (≥1 g/day) develop kidney failure within a decade. Effective therapies that can slow IgAN’s progression to kidney failure are urgently needed.
The findings from this interim analysis are promising, and Novartis intends to seek accelerated approval from the US Food and Drug Administration (FDA) based on these results, with the submission planned for 2024. This accelerated approval application is a significant step forward in advancing the development of atrasentan as a potential therapy for IgAN. It marks the second success for Novartis in IgAN treatment development, with investigational iptacopan, a factor B inhibitor, also demonstrating positive Phase III interim results.
Novartis recently acquired atrasentan and zigakibart (BION-1301) through its acquisition of Chinook Therapeutics. Atrasentan is an investigational ERA that shows promise not only in treating IgAN but also other rare kidney diseases. Zigakibart, on the other hand, is an anti-APRIL monoclonal antibody in Phase III development for IgAN. The addition of these promising late-stage therapies to the Novartis portfolio significantly enhances the company’s offerings for treating rare kidney diseases, including IgAN. Novartis’ commitment to addressing the unmet needs in this area is reflected in the development of these three potential therapeutic options, each with distinct mechanisms of action, to improve the lives of people living with IgAN and other rare kidney diseases.
The ALIGN study will continue in a blinded fashion to evaluate changes in kidney function over 136 weeks, measured by estimated glomerular filtration rate (eGFR). Topline results from the study’s confirmatory endpoint analysis are anticipated in the first quarter of 2026.
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