The ALIGN study, focusing on atrasentan, an investigational oral selective endothelin A (ETA) receptor antagonist, revealed a remarkable 36.1% reduction in proteinuria compared to placebo in patients receiving supportive care with a renin-angiotensin system (RAS) inhibitor. Proteinuria reduction, a pivotal marker for disease progression in IgAN, is a recognized surrogate endpoint correlating with delaying progression to kidney failure.

Commenting on the significance of these findings, Professor Hiddo Heerspink, ALIGN Blinded Steering Committee Chair, emphasized, "ETA receptor activation contributes to elevated proteinuria, often an initial clinical sign of IgAN. The ability of atrasentan to significantly reduce proteinuria underscores its potential as a foundational treatment option for individuals living with IgAN, addressing a critical unmet need in the management of this complex disease."

Bonnie Schneider, Director and Co-Founder of the IgAN Foundation, expressed her optimism, stating, "For those affected by IgAN, the impact extends beyond the physical realm, affecting mental well-being as well. The prospect of new treatments like atrasentan offers hope for a future where individuals have tailored options to manage their condition effectively."

David Soergel, M.D., Global Head, Cardiovascular, Renal and Metabolism Development Unit at Novartis, highlighted the company's commitment to addressing rare kidney diseases, stating, "Atrasentan's potential to transform IgAN management aligns with Novartis' dedication to providing diverse treatment options for a broad patient population, ultimately aiming to improve patient care in this therapeutic area."

The ALIGN study continues in a blinded manner, with final analysis expected to include key secondary endpoints such as changes in estimated glomerular filtration rate (eGFR) and results from participants receiving additional background care. Novartis remains steadfast in its mission to explore innovative treatment options across its rare disease portfolio, with ongoing research efforts showcased at the ERA Congress.