Roche's sefaxersen meets phase III kidney study endpoint

Roche announced on 23 September 2026 positive prespecified interim results from its ongoing phase III IMAgINATION study. The trial evaluates investigational sefaxersen in adults with primary IgA nephropathy, also known as Berger's disease.

The study met its primary endpoint, showing statistically significant and clinically meaningful reductions in proteinuria compared to placebo at 37 weeks. The outcome was measured by the 24-hour urine protein-to-creatinine ratio, an indicator linked to long-term kidney function preservation. Safety and tolerability matched previous trials, with no new safety signals detected.

Sefaxersen is an investigational antisense oligonucleotide designed for once-monthly subcutaneous self-administration, licensed by Roche from Ionis. It targets complement factor B production in the liver. The IMAgINATION trial enrolled 459 participants randomised 1:1 against placebo for 105 weeks, and the double-blind study will continue to evaluate estimated glomerular filtration rate at week 105.

Primary IgA nephropathy is an autoimmune disease affecting at least 25 adults per million each year globally, often diagnosed before age 40. Up to 50% of patients progress to end-stage kidney failure within 20 years. Roche plans to present the interim data at an upcoming medical congress and share findings with health authorities.