Novartis' iptacopan meets goals in rare kidney disease - IgAN

Swiss pharma giant Novartis (NOVN: VX) has announced new mid-stage clinical on iptacopan, one of its lead pipeline products, which are seen as helping the product to set the bar for its rival in the sector.

Phase II primary endpoint data showing investigational iptacopan (LNP023) – a first-in-class, oral, targeted factor B inhibitor – reduced protein in the urine (proteinuria), an increasingly recognized surrogate marker correlating with progression to kidney failure and showed promise in stabilizing kidney function in patients with IgA nephropathy (IgAN). The data were presented at the 58th ERA-EDTA Congress held virtually from June 5–8, 2021.

In the Phase II study (NCT03373461), patients (n=112) with IgAN were randomized to placebo or different doses of iptacopan. The primary endpoint was met with a statistically-significant (p=0.038) dose response effect on reduction in proteinuria (as measured by 24-hour urinary protein to creatine ratio [UPCR 24h]) with iptacopan vs. placebo, at 90 days1. At the highest dose of 200mg twice daily a 23% reduction in proteinuria was predicted, compared with placebo, at 90 days.