Novartis’ atrasentan shows significant reduction in proteinuria in seasonal allergic rhinitis patients

Novartis presented compelling interim results from the Phase III ALIGN study evaluating the efficacy of atrasentan, an investigational oral selective endothelin A (ETA) receptor antagonist, in patients with IgA nephropathy (IgAN). This data was highlighted at the European Renal Association (ERA) Congress, showcasing a significant 36.1% reduction in proteinuria at 36 weeks compared to placebo, along with a favorable safety profile consistent with previous studies.

Clinical Trial Insights and Patient Impact

The ALIGN trial enrolled 340 patients with biopsy-proven IgAN, who were at risk of progressive kidney function loss despite receiving optimized renin-angiotensin system (RAS) inhibitor treatment. Patients treated with atrasentan experienced a marked reduction in proteinuria—a key indicator linked to the slowing of kidney disease progression and a surrogate marker often used to support accelerated drug approvals.

Bonnie Schneider, Director and Co-Founder of the IgAN Foundation, shared her personal connection to the disease: “When my son Eddie was diagnosed with IgAN 20 years ago, there were no FDA-approved medicines. That was as devastating as the diagnosis itself. It’s a disease that affects people differently, and we are excited for a future where the community will have more treatment options.”

Novartis Reports Promising Interim Results from Phase III ALIGN Study on Atrasentan for IgA Nephropathy

Ongoing Research and Future Directions

The ALIGN study is ongoing and remains blinded, with further results anticipated in 2026. This includes a key secondary endpoint assessing the change from baseline in estimated glomerular filtration rate (eGFR) at 136 weeks. Additionally, an exploratory cohort of patients receiving a sodium-glucose co-transporter-2 (SGLT2) inhibitor is also part of the study.

Professor Hiddo Heerspink, Chair of the ALIGN Steering Committee, emphasized the need for targeted treatments: “Patients with persistent proteinuria have a poorer prognosis and are more likely to progress to kidney failure. These data from the ALIGN study further demonstrate atrasentan’s potential as a foundational treatment for IgAN.”

Novartis’ Commitment to Advancing IgAN Treatment

David Soergel, M.D., Global Head of the Cardiovascular, Renal and Metabolism Development Unit at Novartis, highlighted the broader implications: “Atrasentan has the potential to transform IgAN management for many. Our multi-product IgAN portfolio aims to address the needs of a diverse patient population with different modes of action, improving care in this therapeutic area.”

Novartis also presented new data across its rare disease portfolio at the ERA Congress, including results from studies on Fabhalta (iptacopan) in C3 glomerulopathy (C3G), additional data for Fabhalta in IgAN, and investigational treatments in other rare kidney diseases.