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Novartis's Iptacopan Aces Mid-Stage Kidney Disease Trial

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  • Novartis AG (NYSE: NVS) announced data from Phase 2 trial evaluating iptacopan (LNP023) in rare kidney disease IgA nephropathy (IgAN). Data were presented at the 58th ERA-EDTA Congress.

  • IgA nephropathy, also known as Berger's disease, occurs when an antibody called immunoglobulin A (IgA) builds up in kidneys, resulting in local inflammation that, over time, can hamper kidneys' ability to filter waste.

  • The trial met its primary endpoint data showing the targeted factor B inhibitor reduced protein in the urine (proteinuria), an increasingly recognized surrogate marker correlating with progression to kidney failure.

  • In the study, a statistically significant dose-response effect on reduction in proteinuria with iptacopan was observed compared to placebo at 90 days.

  • At the highest dose of 200mg twice daily, a 23% reduction in proteinuria was predicted, compared with placebo, at 90 days.

  • Iptacopan also demonstrated a trend towards stabilizing kidney function, as assessed by estimated glomerular filtration rate (eGFR), a key measure of kidney clearance function.

  • Additionally, iptacopan showed a favorable safety and tolerability profile.

  • Iptacopan is in development for several complement-driven renal diseases (CDRDs), including IgAN and C3 glomerulopathy (C3G), and the blood disorder paroxysmal nocturnal hemoglobinuria (PNH), targeting a vital driver of these diseases.

  • Price Action: NVS shares are down 0.01% at $89.79 during the market session on the last check Monday.

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