Ionis partner Roche reports sefaxersen cut proteinuria 43.1% in Phase 3 study
Data from the IMAgINATION study in adults with primary IgA nephropathy were presented at ASN Kidney Week 2026, the filing said.
Key takeaways
- Ionis Pharmaceuticals Inc. (IONS) said in a regulatory filing that partner Roche reported Phase 3 IMAgINATION study data on Oct. 23 showing investigational sefaxersen reduced proteinuria by 43.1% relative to placebo at 37 weeks in adults with primary IgA nephropathy. The data were presented at ASN Kidney Week 2026.
Ionis Pharmaceuticals Inc. (IONS) said in a regulatory filing that its partner Roche announced on Oct. 23 late-breaking oral presentation data from the Phase 3 IMAgINATION study.
The study tested investigational sefaxersen in adults with primary IgA nephropathy, or IgAN, who were receiving optimized standard of care. Sefaxersen achieved a 43.1% reduction in proteinuria relative to placebo at 37 weeks, measured by 24-hour urine protein-to-creatinine ratio.
The 95% confidence interval was 32.5 to 52.0, and the P value was below 0.0001.
Proteinuria is an indicator of kidney damage. The release said a reduction in urine protein is strongly associated with the preservation of long-term kidney function.
Results presented at the American Society of Nephrology Kidney Week 2026 also showed that, among patients with baseline hematuria, a greater proportion achieved hematuria resolution at Week 37 with sefaxersen than with placebo.
The treatment effect was consistent across all prespecified subgroups. The company said sefaxersen was well tolerated, with a safety profile consistent with the previously reported Phase 2 study and no new safety signals.
Chief executive officer Brett P. Monia, Ph.D., said the data "support our belief that sefaxersen is uniquely positioned to treat IgA nephropathy."
Sefaxersen is an investigational once-monthly subcutaneous injection designed for self-administration. The IMAgINATION study will continue as a blinded study to evaluate change in kidney function over two years, measured by estimated glomerular filtration rate at week 105.
Roche will share the data with health authorities, with the goal of bringing the treatment to patients as soon as possible. The filing did not give a regulatory submission or approval date.
Roche licensed sefaxersen from Ionis for the treatment of complement-mediated diseases. Ionis received an upfront payment, a license fee and development milestone payments, and is eligible for regulatory and sales milestone payments as well as tiered royalties on net sales.