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.

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.

“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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.