RARE Daily

Novartis Reports Positive Interim Results from Phase 3 Study of Treatment for IgAN

May 28, 2024

Rare Daily Staff

Novartis reported positive results for its experimental therapy atrasentan for the rare kidney disease IgA nephropathy from a pre-specified interim analysis in its phase 3 ALIGN study.

Patients treated with atrasentan, in addition to supportive care, achieved a 36.1 percent reduction in proteinuria at 36 weeks when compared to placebo on top of supportive care. Proteinuria reduction is a recognized surrogate marker correlating with delaying progression to kidney failure and has been used as an endpoint in IgAN clinical trials to support accelerated regulatory approvals.

The study also showed that atrasentan has a favorable safety profile consistent with previously reported data. The results were presented during a late-breaking clinical trials session at the European Renal Association Congress. Novartis said U.S. Food and Drug Administration submission for atrasentan in IgAN is on track for the first half of 2024.

IgA nephropathy (IgAN), also known as Berger’s disease, is a serious and progressive autoimmune disease of the kidney, for which there remains a high unmet medical need. IgAN is driven by the production of immunogenic Gd-IgA, which triggers autoantibodies that lead to the formation of pathogenic immune complexes, which become trapped in the kidney’s glomeruli, causing inflammation and progressive damage. In up to half of patients, IgAN can lead to end-stage kidney disease or kidney failure, which has considerable morbidity and impact on patients’ lives.

Atrasentan is an experimental potent and selective oral ETA receptor antagonist, currently in Phase III development for IgAN and early-stage development for other rare kidney diseases. Activation of the ETA receptor contributes to elevated proteinuria, which is associated with kidney damage, fibrosis and loss of kidney function in IgAN. Atrasentan has potential to be added to current supportive therapy to reduce persistent proteinuria and preserve kidney function for a broad patient population. Preclinical models have also suggested that atrasentan may reduce inflammation and fibrosis in IgAN.

“Atrasentan has the potential to help transform how IgAN is managed for many people living with this complex illness,” said David Soergel, global head of Cardiovascular, Renal and Metabolism Development Unit at Novartis. “Our multi-product IgAN portfolio aims to address the needs of a broad, heterogenous patient population with different modes of action to target distinct drivers of the disease, with the ultimate goal of improving patient care in this therapeutic area.”

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