Novartis says Phase 3 APPLAUSE-IgAN study met interim analysis primary endpoint

Novartis announced positive top-line results from the pre-specified interim analysis of the Phase III APPLAUSE-IgAN study at 9 months. Iptacopan, an investigational factor B inhibitor targeting the alternative complement pathway, demonstrated superiority versus placebo in proteinuria reduction and provided a clinically meaningful and highly statistically significant proteinuria reduction on top of supportive care in patients with IgA nephropathy, or IgAN. In the study, the safety profile of iptacopan 200 mg twice daily was consistent with previously reported data. The study continues in a double-blind fashion to evaluate iptacopan’s ability to slow IgAN progression by measuring estimated glomerular filtration rate slope over 24 months – the primary endpoint at the study end with topline results expected in 2025. “These positive data from the Phase III APPLAUSE study reinforce the potential of iptacopan to provide clinically meaningful benefit to patients with IgAN, a debilitating disease that affects mostly young adults,” said Shreeram Aradhye, M.D., President, Development and Chief Medical Officer, Novartis. “We are excited about this milestone in the development of our factor B inhibitor of the alternative complement pathway and remain focused on further advancing our portfolio of renal programs through pivotal trials.”