Novartis has shared positive results from a late-stage trial of its experimental drug atrasentan in patients with IgA nephropathy (IgAN), a rare kidney disease.
Affecting approximately 110,000 people in the US, IgAN occurs when IgA accumulates in the kidneys and damages them. This impairs their filtering function and, as a result, the kidneys start to let substances such as blood and protein leak into the urine.
IgAN is a major cause of chronic kidney disease and kidney failure, with up to 30% of IgAN patients with persistently higher levels of proteinuria progressing to kidney failure within ten years.
The phase 3 ALIGN study has been evaluating atrasentan, an investigational oral endothelin A receptor antagonist, in patients with IgAN at risk of progressive loss of kidney function.
The study met its primary efficacy endpoint at the 36-week interim analysis, with atrasentan demonstrating superiority versus placebo with a clinically meaningful and highly statistically significant reduction in proteinuria (protein in urine) in patients with IgAN receiving supportive care.
The safety profile of atrasentan was also consistent with previously reported data from the phase 2 AFFINITY study IgAN cohort, Novartis said, adding that it plans to submit an application next year for the possible accelerated approval of the candidate in the US.
Shreeram Aradhye, president, development and chief medical officer at Novartis, said: “This positive topline phase 3 data showcases the potential of atrasentan to improve outcomes for patients with IgAN by demonstrating clinically meaningful proteinuria reduction.”
Atrasentan was added to Novartis’ portfolio earlier this year through the company’s $3.5bn acquisition of Chinook Therapeutics, along with zigakibart, a subcutaneously administered anti-APRIL monoclonal antibody in late-stage development for IgAN.
Novartis’ pipeline also includes iptacopan, an experimental factor B inhibitor that recently achieved positive phase 3 interim results in IgAN.
“Along with investigational iptacopan, which recently also showed positive topline phase 3 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 Aradhye.