Novartis’ atrasentan shows promise in Phase 3 trial for IgA nephropathy
Novartis announced encouraging interim results from its pivotal Phase III ALIGN study (NCT04573478) involving atrasentan, an oral endothelin A receptor antagonist, for patients with IgA nephropathy (IgAN), in a press release.
The study has successfully met its primary efficacy endpoint at the 36-week interim analysis, showcasing atrasentan’s superiority over placebo. The treatment demonstrated a clinically substantial and statistically significant reduction in proteinuria (protein in urine) for patients with IgAN receiving supportive care, defined as the maximally tolerated and stable dose of a renin-angiotensin system inhibitor.
The safety profile of atrasentan aligns with previously published data from the Phase 2 AFFINITY study IgAN cohort. Given these promising results in proteinuria reduction, Novartis is poised to submit an application for potential accelerated approval in the United States in 2024.
Shreeram Aradhye, MD, President, Development and Chief Medical Officer at Novartis, expressed optimism, stating, “These positive Phase 3 data highlight atrasentan’s potential to enhance outcomes for IgAN patients by demonstrating a clinically significant reduction in proteinuria.”
The ALIGN study will persist in a blinded format to evaluate changes in kidney function over 136 weeks, measured by estimated glomerular filtration rate (eGFR). Topline results from the confirmatory endpoint analysis are anticipated in the first quarter of 2026.