A 43.1% reduction in proteinuria is a number that demands attention in IgA nephropathy, where slowing kidney function decline has historically depended on blood pressure control and immunosuppression rather than anything targeting the disease’s upstream driver. Roche presented those results from the Phase 3 IMAgINATION study at a late-breaking oral session on October 23, 2026, covering adults with primary IgAN on optimized standard of care who received investigational sefaxersen, an antisense therapy developed with Ionis Pharmaceuticals. The 95% confidence interval ran from 32.5% upward, placing the floor of the effect well above what a noisy trial might produce by chance.
The design detail that sharpens the finding is the “optimized standard of care” backdrop. Patients were already on the best available supportive therapy, which means sefaxersen’s proteinuria reduction came on top of that baseline, not instead of it. Proteinuria is a validated surrogate in IgAN trials because sustained elevation predicts glomerular filtration rate loss over years, so a nearly 43% cut at the population level translates directly to the kidney-function trajectory regulators and nephrologists care about most.
Sefaxersen targets APRIL, a cytokine that drives the galactose-deficient IgA1 overproduction sitting at the root of IgAN pathology. Antisense inhibition of a hepatically expressed target fits the Ionis platform well, and IMAgINATION is ongoing, meaning the proteinuria data presented here are not the trial’s final word. Whether the eventual primary or secondary endpoints include hard kidney-function outcomes will determine how much regulatory weight this readout ultimately carries, and the filing does not specify what those later milestones look like on a timeline.
For trial watchers, the number to follow from here is the estimated glomerular filtration rate slope in IMAgINATION’s longer-term follow-up cohort. Proteinuria response alone can support approval in some regulatory pathways, but durability of kidney protection is what will settle the drug’s clinical position.
Source link: https://www.sec.gov/Archives/edgar/data/874015/000114036126040631/ef20084325_8k.htm
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
