- An experimental kidney disease drug Novartis acquired via a $3 billion deal earlier this year succeeded in a late-stage trial, the Swiss pharmaceutical company said Monday.
- The drug, called atrasentan, reduced protein in the urine of people with IgA nephropathy by significantly more than placebo, meeting the Phase 3 trial’s goal. IgA nephropathy is a leading cause of chronic kidney disease and often causes persistently high urine protein, or proteinuria.
- With the positive data in hand, Novartis plans to submit an application to U.S. regulators for accelerated approval of the drug. The company’s trial will continue to run for another two years to assess changes in kidney function over time.
Novartis put a bet on atrasentan succeeding in its Phase 3 trial when it agreed in June to buy the drug’s developer, Chinook Therapeutics, for up to $3.5 billion. The deal also gave Novartis another IgAN drug called zigakibart that, together with its internally developed therapy iptacopan, the company envisions forming the foundation of a kidney disease portfolio.
While there are approved drugs on the U.S. market for IgAN, none are curative. Treatments like those from Chinook, as well as other developers like Alnylam Pharmaceuticals, could expand the number of options available.
The data disclosed by Novartis suggests atrasentan could be one. The company didn’t disclose detailed study findings, but said the drug outperformed placebo with a “clinically meaningful and highly statistically significant reduction in proteinuria.” Atrasentan’s safety profile was consistent with past data, it added.
“Along with investigational iptacopan, which recently also showed positive topline Phase III results, and investigational zigakibart, our development portfolio of three highly differentiated late-stage therapies in IgAN has the potential to provide much-needed treatment options for people living with this debilitating disease,” said Novartis Chief Medical Officer Shreeram Aradhye in a statement.
The trial enrolled about 340 people with IgAN who had high urine protein levels despite ongoing treatment. Participants were then randomized to receive either atrasentan or placebo. Change in urine protein levels was measured at 36 weeks, leading to Novartis’ announcement Monday.
The study will also assess kidney function via a measure known as estimated glomerular filtration rate at 136 weeks. That data is expected in the first quarter of 2026.
A progressive and rare autoimmune condition, IgAN typically affects young adults. Approximately 160,000 people are estimated to have the disease in the U.S. and major European countries, according to Novartis.