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Roche's sefaxersen cuts proteinuria 43.1% versus placebo in interim phase III IgA nephropathy data

Roche · Fri 23 Oct 2026

Interim IMAgINATION results presented at ASN Kidney Week show a proteinuria reduction at week 37 and no new safety signals, with eGFR data still to come.

Roche has reported interim phase III results for sefaxersen in primary IgA nephropathy. The data from the IMAgINATION study were presented at ASN Kidney Week on 23 October 2026.

Sefaxersen is an investigational antisense inhibitor of complement factor B, given as a once-monthly subcutaneous injection. In adults with primary IgA nephropathy, it reduced proteinuria by 43.1% compared with placebo at week 37.

Roche said the study showed no new safety signals. The summary available does not give further detail on adverse events, patient numbers or the exact proteinuria measure used.

IMAgINATION remains blinded through week 105, when eGFR will be assessed. Roche said it plans to share the data with health authorities, but it has not stated a timeline or which regulators it will approach.

What it means for your team

  • The 43.1% proteinuria reduction is an interim, week-37 result; kidney function (eGFR) outcomes through week 105 are still blinded and will matter most for the regulatory case.
  • Roche intends to discuss the data with health authorities, but no submission dates have been disclosed, so filing timelines remain unclear.
  • Safety teams should note the 'no new safety signals' statement is high level; full safety tables will be needed for proper assessment.
  • Market-access teams should treat this as early evidence for a complement-targeting option in IgA nephropathy, with pricing and positioning dependent on final eGFR data.

Company's press release: Roche ↗

Article written by VigiEye from the official source (Roche). Claims are the company's own. AI-assisted; check the source before acting.

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