Roche reports 43.1% reduction in proteinuria in Phase 3 kidney-disease trial

Roche reported detailed Phase 3 IMAgINATION results for sefaxersen, an investigational treatment for primary IgA nephropathy (IgAN). At week 37, it reduced proteinuria by 43.1% versus placebo (95% CI 32.5%–52.0%; p<0.0001), on top of optimised standard care.

Proteinuria is a marker of kidney damage. The trial also found that more participants with blood in their urine at baseline had resolution of haematuria on sefaxersen than on placebo.

The company said the drug was well tolerated, with no new safety signals and a profile consistent with earlier Phase 2 results.

The 459-participant study remains ongoing:
treatment is planned for 105 weeks, allowing researchers to assess longer-term kidney function. Roche plans to share the interim findings with regulators.

Sefaxersen is a monthly injection licensed from Ionis Pharmaceuticals. Roche has cited potential peak sales of 1–2 billion Swiss francs, though that is a company forecast, not a guaranteed outcome. The reported week-37 result is an improvement in a kidney-damage marker; longer-term outcomes and regulatory decisions remain outstanding.