SOUTH SAN FRANCISCO (dpa-AFX) - Roche (RHHBY) announced new late-breaking data from the ongoing Phase III IMAgINATION study showing that its investigational therapy sefaxersen delivered a statistically significant and clinically meaningful reduction in proteinuria in adults with primary IgA nephropathy (IgAN) receiving optimized standard of care.
Results presented at the American Society of Nephrology (ASN) Kidney Week 2026 showed that patients treated with sefaxersen achieved a 43.1% reduction in proteinuria relative to placebo at Week 37, as measured by the 24-hour urine protein-to-creatinine ratio (UPCR), the study's primary endpoint.
Proteinuria, or excess protein in urine, is a key marker of kidney damage in IgAN, and lowering proteinuria is strongly associated with preserving long-term kidney function. The study also demonstrated that among patients with baseline haematuria (blood in the urine), a greater proportion of those receiving sefaxersen achieved haematuria resolution by Week 37 compared with placebo.
According to Roche, treatment benefits were consistent across all prespecified patient subgroups, supporting the robustness of the findings. The company also reported that sefaxersen was well tolerated, with a safety profile consistent with results from the previously reported Phase II study and no new safety signals identified.
Sefaxersen is an investigational once-monthly subcutaneous injection designed for self-administration, potentially offering a convenient treatment option for people living with IgAN, a chronic kidney disease that can progress to kidney failure.
The IMAgINATION trial will continue in a blinded phase to assess long-term kidney function outcomes. The study's key secondary endpoint evaluates changes in estimated glomerular filtration rate (eGFR) at Week 105, providing insight into the therapy's potential to slow disease progression over time.
Roche obtained rights to develop and commercialize sefaxersen from Ionis Pharmaceuticals under a licensing agreement covering the treatment of complement-mediated diseases.
RHHBY closed Friday's regular trading at $61.17 up $1.55 or 2.60%.
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