Novartis has presented the results of a pre-specified interim analysis of the Phase III ALIGN study of atrasentan, an investigational oral selective endothelin A receptor (ETA) antagonist, in patients with IgA nephropathy (IgAN).

Patients treated with atrasentan achieved a 36.1% (p < 0.0001) reduction in proteinuria (measured by the 24-hour urine protein/creatinine ratio [UPCR]) at 36 weeks versus placebo, in addition to supportive care.

The results were presented at a late-breaking clinical trial session at the European Renal Association (ERA) congress.

The US FDA application for atrasentan in IgAN is on track for the first half of 2024.

' ''These data from the ALIGN study once again demonstrate atrasentan's ability to significantly reduce proteinuria and, if approved, its potential to become a fundamental new treatment for people living with IgAN that can be seamlessly added to current supportive therapy,'' said Professor Hiddo Heerspink of Groningen University Medical Center and chairman of ALIGN's blinded steering committee.

' Our multi-product IgAN portfolio aims to address the needs of a broad and heterogeneous patient population with different modes of action to target different disease drivers, with the ultimate goal of improving patient care in this therapeutic area. said David Soergel, M.D., Global Head of Novartis Cardiovascular, Renal and Metabolic Development.

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