Research

Roche and Ionis report positive Phase 3 interim results for IgAN drug

Roche said sefaxersen lowered urine protein in a Phase 3 interim analysis, but detailed results have not been disclosed.

Reported by 2 outlets Thursday, September 24, 2026

Gloved hands pouring liquid in a laboratory — Photo: Public domain, U.S. Department of Agriculture

Roche and Ionis said a prespecified interim analysis of the Phase 3 trial found sefaxersen produced a statistically significant and clinically meaningful reduction in urine protein levels in people with immunoglobulin A nephropathy, or IgAN. The companies did not disclose detailed results.

Sefaxersen is an antisense oligonucleotide designed to suppress production of complement factor B. It is given as a monthly injection, according to BioPharma Dive. Roche said patients may administer it at home. By comparison, the existing drug Fabhalta is a twice-daily pill.

The trial remains blinded and will continue to assess the drug’s effect on kidney function over two years, MedCity News reported. Roche said results will be presented at an upcoming medical conference and shared with regulatory authorities. MedCity News reported that the urine-protein results could support an application for accelerated FDA approval.

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