Novartis Announces Positive Results From Phase III Study Of Atrasentan In IgA Nephropathy

(RTTNews) - Novartis (NVS) announced positive results from the interim analysis of the ongoing pivotal Phase III ALIGN study of atrasentan, an oral endothelin A receptor antagonist or ERA, in patients with IgA nephropathy or IgAN.

IgAN is a major cause of chronic kidney disease and kidney failure, and mostly affects young adults.

The company noted that the Phase III ALIGN 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.

In the study, the safety profile of atrasentan was consistent with previously reported data from the Phase II AFFINITY study IgAN cohort. Novartis plans to submit an application in 2024 for possible accelerated approval in the US.

Novartis noted that it is advancing the development of three potential therapeutic options, with different mechanisms of action, to address unmet needs in IgAN and other rare kidney diseases.

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 (eGFR), with topline results from the confirmatory endpoint analysis expected in the first quarter of 2026.

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