Novartis Announces Positive Topline Results from Phase III ALIGN Study of Atrasentan in IgA Nephropathy

On October 30, Novartis announced that the Phase III ALIGN study of its oral, highly selective endothelin A (ETA) receptor antagonist Atrasentan for the treatment of IgA nephropathy achieved positive results in a 36-week interim analysis, meeting the primary efficacy endpoint with a significant reduction in proteinuria.

IgA nephropathy is a glomerular disease characterized by the deposition of immune complexes predominantly composed of immunoglobulin A in the mesangial area of the glomerulus. It is also the most common primary glomerulonephritis worldwide, frequently observed in young individuals, and is a major cause of chronic kidney disease and renal failure globally.

Atrasentan, acquired by Novartis in June this year for $3.5 billion from Chinook Therapeutics, is being developed for IgA nephropathy and other rare kidney diseases.

The ALIGN study, announced this time, is a global, randomized, multicenter, double-blind, placebo-controlled Phase III clinical trial aimed at evaluating the efficacy and safety of Atrasentan compared to placebo in IgA nephropathy patients at risk of progressive loss of kidney function. In the study, approximately 340 patients with biopsy-confirmed IgA nephropathy and baseline total proteinuria exceeding 1g/day were randomly assigned to receive either 0.75mg of Atrasentan once daily or a placebo for about 2.5 years. During this period, patients continued to receive maximally tolerated and dose-stable RAS blockers as supportive therapy.

The primary endpoint of the study was the change in patients' urine protein-to-creatinine ratio (UPCR) from baseline at 36 weeks. Secondary endpoints included the change in estimated glomerular filtration rate (eGFR) from baseline at 136 weeks, as well as safety and tolerability.

Analysis of the 36-week period showed that, compared with placebo, the Atrasentan treatment group demonstrated a statistically and clinically significant reduction in proteinuria, with safety consistent with previous studies. Based on these results, Novartis plans to submit a marketing application in 2024 to obtain FDA accelerated approval, with the primary results of the confirmatory endpoint analysis expected to be announced in the first quarter of 2026.

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