Roche is looking to take on Novartis after a Phase III trial of sefaxersen in primary IgA nephropathy (IgAN) met its endpoints.
In the IMAgINATION study (NCT05797610), prespecified interim data found the trial had met its primary endpoint of statistically significant and clinically meaningful improvements in proteinuria reduction, compared to placebo at 37 weeks, as measured by 24-hour urine protein-to-creatinine ratio (UPCR).
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Proteinuria is a key indicator of kidney damage, and a reduction in UPCR is strongly associated with the preservation of long-term kidney function.
Bonnie Schneider, director and co-founder of the IgA Nephropathy Foundation, said: “For patients and families navigating IgAN, the prospect of kidney failure, dialysis, or transplantation creates overwhelming uncertainty. As someone who has advocated for this community for over two decades, positive results from the IMAgINATION study give us hope that emerging therapies could help preserve kidney function and transform the treatment landscape.”
The IMAgINATION study will continue as a blinded study to evaluate the change in kidney function over two years, as measured by estimated glomerular filtration rate (eGFR) at week 105.
Roche will share interim data of the $55m Ionis-partnered drug at an upcoming medical congress, as well as with health authorities as it seeks accelerated approval on the 37-week data.
IgAN, also known as Berger’s disease, is a chronic and progressive autoimmune disease that leads to end-stage kidney disease in up to 50% of patients within 20 years of diagnosis.
Novartis gained US Food and Drug Administration (FDA) approval for its drug Fabhalta (iptacopan) to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression in July 2026.
This marked the first complement inhibitor to gain approval, with both Novartis and Roche targeting complement factor B with their respective drugs. While there were approved medications for IgAN before this, this modality of drugs is seen as an advancement for patients.
Sefaxersen is a once-monthly subcutaneous injection designed to enable self-administration for people with IgAN and acts by stopping the production of factor B at the messenger RNA level. Meanwhile, Novartis’ Fabhalta is an oral, small molecule taken twice daily that directly binds to and inhibits complement factor B.
Vertex is also seeking approval of povetacicept in IgAN after the Phase III RAINER trial (NCT06564142) met its primary endpoint.
Otsuka’s Voyxact (sibeprenlimab-szsi) recently gained FDA approval in November 2025, and there are more established therapies on the market, including Calliditas Therapeutics’ Tarpeyo (budesonide) and Travere Therapeutics’ Filspari (sparsentan).
