Ionis partner Roche reports sefaxersen cut kidney-damage marker 43% in Phase 3 IgA nephropathy study

Ionis Pharmaceuticals said Friday that its experimental kidney drug sefaxersen, licensed to Roche, reduced proteinuria by 43.1% compared with placebo at 37 weeks in a Phase 3 study of adults with IgA nephropathy, according to an 8-K filing.

The result from the IMAgINATION trial was statistically significant (P<0.0001), and Roche presented the late-breaking data at the American Society of Nephrology's Kidney Week 2026, the filing said. Proteinuria, measured by the 24-hour urine protein-to-creatinine ratio, is a key indicator of kidney damage.

Why it matters for Ionis

Roche licensed sefaxersen from Ionis for complement-mediated diseases. Ionis has already received an upfront payment, a license fee and development milestone payments, and is eligible for regulatory and sales milestones plus tiered royalties on net sales, according to the 8-K.

Roche will share the data with health authorities "with the goal of bringing this treatment to patients as soon as possible," the company said.

"Based on these positive data, we believe it has the potential to be an important new treatment option for people living with IgA nephropathy," Ionis Chief Executive Brett P. Monia said in the press release attached to the filing.

What the trial showed

The treatment effect was consistent across all prespecified subgroups, and among patients with blood in their urine at baseline, more patients on sefaxersen than on placebo saw it resolve by week 37. The drug was well tolerated, with no new safety signals compared with the earlier Phase 2 study, Ionis said.

Sefaxersen is a once-monthly injection under the skin designed for self-administration. The 459-patient study continues blinded to measure kidney function over two years, using estimated glomerular filtration rate at week 105.

IgA nephropathy, also called Berger's disease, is a chronic autoimmune kidney disease that leads to end-stage kidney disease in up to 50% of patients within 20 years of diagnosis, according to the release.

By the numbers

• Proteinuria reduction vs. placebo at 37 weeks: 43.1%
• 95% confidence interval: 32.5% to 52.0%
• Patients enrolled: 459
• Dosing: once monthly, subcutaneous
• Kidney-function readout: week 105

Sources

1. Ionis Pharmaceuticals, Inc., Form 8-K with Exhibit 99.1 filed Oct. 23, 2026, accession 0001140361-26-040631

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