Novartis has unveiled interim results from the Phase III ALIGN clinical trial where atrasentan showed to reduce proteinuriain Immunoglobulin A nephropathy (IgAN) patients.
The global, double-blind, randomised, multicentre, placebo-controlled trial is designed to assess the efficacy and safety of atrasentan versus placebo in IgAN patients at risk of progressive kidney function loss.
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The trial enrolled 340 subjects with biopsy-proven IgAN and proteinuria levels of a minimum of 1g/day, despite optimised treatment with renin-angiotensin system (RAS) inhibitors.
Participants received either a daily oral dose of atrasentan 0.75mg or a placebo, alongside a stable dose of RAS inhibitors, over a period of approximately 2.5 years.
An additional cohort of 64 patients on a stable dose of SGLT2 inhibitors for a minimum of 12 weeks was also included.
The primary efficacy goal of the study is to assess the variation in proteinuria.
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By GlobalDataAnalysing kidney function changes over 136 weeks and evaluating safety and tolerability are the trial’s secondary and exploratory objectives, respectively.
The interim analysis revealed that atrasentan treatment led to a 36.1% reduction in proteinuria at 36 weeks, a statistically significant improvement over placebo.
Atrasentan’s safety profile in the trial was deemed favourable, aligning with previous data.
Proteinuria reduction is a key surrogate marker for delaying kidney failure and is often used to support accelerated regulatory approvals in IgAN clinical trials.
The company plans to make the US Food and Drug Administration (FDA) submission for atrasentan in IgAN indication in the first half of this year.
While the ALIGN study is ongoing and remains blinded, the final analysis, including the secondary endpoint and results from the exploratory cohort, is expected in 2026.
Novartis Cardiovascular, Renal and Metabolism Development Unit global head David Soergel said: “Atrasentan has the potential to help transform how IgAN is managed for many people living with this complex illness.
“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.”
In April this year, the company reported pre-specified interim analysis data from the Phase III APPLAUSE-IgAN trial of Fabhalta (iptacopan) in IgAN patients.
