Ionis: Sefaxersen Phase 3 interim data meet primary endpoint in IgA nephropathy
Ionis and partner Roche reported positive prespecified interim results from the ongoing Phase 3 IMAgINATION study of investigational sefaxersen in adults with primary IgA nephropathy. The study met its primary endpoint, with statistically significant and clinically meaningful reductions in proteinuria versus placebo at 37 weeks, and no new safety signals were identified. The results advance a candidate that Roche licensed from Ionis, and Ionis is eligible for regulatory and sales milestone payments and royalties under that agreement.
Key points
- Primary endpoint met: statistically significant reduction in 24-hour urine protein-to-creatinine ratio versus placebo at 37 weeks
- Study enrolled 459 people, randomized 1:1 to sefaxersen or placebo for 105 weeks
- Safety and tolerability were consistent with previously reported data, with no new safety signals
- The study continues as a blinded study to assess change in eGFR at week 105; interim data will be presented at an upcoming medical congress, date not given
The filing
Written by AI on Nov 9, 2026, 8:28 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on September 23, 2026.
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