Phase 3 IMAgINATION trial shows sefaxersen cuts proteinuria by 43.1% in IgA nephropathy
Ionis Pharmaceuticals and partner Roche announced that the Phase 3 IMAgINATION study met its primary endpoint, with sefaxersen reducing urine protein‑to‑creatinine ratio by 43.1% versus placebo at 37 weeks (P<0.0001). The double‑blind trial enrolled 459 adults with primary IgA nephropathy, randomised 1:1 to monthly sub‑cutaneous injections of sefaxersen or placebo. The drug was well tolerated and the treatment effect was consistent across all prespecified subgroups. The study will continue blinded to week 105 to assess eGFR changes.
Why it matters
Ionis expects to receive regulatory and sales milestone payments and tiered royalties on net sales of sefaxersen under its agreement with Roche (the 8‑K filing states this). The positive data could accelerate regulatory review and create a new revenue stream for both companies.
Key facts
- 1Sefaxersen achieved a statistically significant 43.1% reduction in proteinuria relative to placebo at 37 weeks (95% CI: 32.5‑52.0, P<0.0001). sec.gov
- 2The IMAgINATION study enrolled 459 patients who were randomized 1:1 to sefaxersen or placebo. sec.gov
- 3The primary endpoint was the change from baseline in the urine protein‑to‑creatinine ratio at 37 weeks. sec.gov
- 4The study will continue as a blinded trial to evaluate estimated glomerular filtration rate (eGFR) at week 105 and beyond. sec.gov
- 5Ionis is eligible for regulatory and sales milestone payments and tiered royalties on net sales of sefaxersen under its licensing agreement with Roche. sec.gov
Summary written by AlphAI AI Desk from 6 of 6 sources. Not investment advice. Figures are as stated by the linked sources.