Novartis AG NVS released topline results from the interim analysis of the ongoing pivotal Phase 3 ALIGN study of atrasentan in patients with IgA nephropathy (IgAN).
IgAN is a major cause of chronic kidney disease and kidney failure and mostly affects young adults.
Atrasentan, an investigational oral endothelin A receptor antagonist in development for IgAN and other rare kidney diseases, was added to the Novartis portfolio through the recent acquisition of Chinook Therapeutics.
The study met its primary efficacy endpoint at the 36-week interim analysis.
Atrasentan demonstrated 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.
The ALIGN study continues in a blinded manner to evaluate the change in kidney function over 136 weeks as measured by estimated glomerular filtration rate, with topline results from the confirmatory endpoint analysis expected in Q1 of 2026.
Price Action: NVS shares are up 1.68% at $93.82 on the last check Monday.
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