The results from the placebo-controlled Phase III Applause-IgAN study (NCT04578834) are the third positive Phase III trial for iptacopan. Image Credit: JHVEPhoto / Shutterstock.

Novartis has announced positive interim results for iptacopan from the Phase III Applause-IgAN study showing significant proteinuria reduction in patients with IgA nephropathy (IgAN).

IgAN is a complement-mediated chronic kidney disease where the immunoglobulin A (IgA) gets trapped in the kidney glomeruli, causing damage and scarring to the whole kidney.

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Iptacopan is a factor B binding proximal complement inhibitor that inhibits the alternative complement pathway.

The drug has not been successful across all trials, as Novartis had to terminate the Phase II trial, which compared iptacopan with Roche’s Rituxan (rituximab) in membranous glomerulonephritis.

The results from the placebo-controlled Phase III Applause-IgAN study (NCT04578834) are the third positive Phase III trial for iptacopan. In light of these findings, Novartis plans to submit for possible accelerated approval with the US Food and Drug Administration (FDA) in 2024.

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“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, chief medical officer at Novartis.

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The Applause-IgAN trial’s primary endpoint is to evaluate iptacopan’s ability to slow IgAN progression by measuring the estimated glomerular filtration rate (eGFR) slope over 24 months. The topline results from the study are expected in 2025.

Iptacopan clinical trials

It is being investigated across five indications including paroxysmal nocturnal haemoglobinuria (PNH). The rare blood order trial (NCT04558918) met its primary endpoint in April.

The drug is being evaluated for the treatment of C3 glomerulopathy in a Phase III study (NCT04817618). Other indications that iptacopan is being investigated for include atypical haemolytic uremic syndrome (NCT04889430) and immune complex membranoproliferative glomerulonephritis (NCT05755386).

In August, Novartis acquired Chinook Therapeutics to bolster its portfolio of drugs targeting kidney disease. The deal included two IgAN drugs, atrasentan and zigakibart, which are in Phase III development. A pivotal data readout for the Phase III atrasentan trial is planned for Q4 2023.