Ionis partner Roche's sefaxersen cuts proteinuria 43.1% versus placebo in Phase 3 IgAN trial
IONS•Roche reported that sefaxersen reduced proteinuria by 43.1% versus placebo at week 37 in the Phase 3 IMAgINATION trial for IgA nephropathy. The reduction was statistically significant, and the blinded trial will continue to assess kidney function at week 105.
1. Trial results
Sefaxersen reduced proteinuria by 43.1% versus placebo at week 37, with a 95% confidence interval of 32.5%-52% and P<0.0001. Treatment effects were consistent across prespecified subgroups; the investigational monthly injection was well tolerated, with no new safety signals. The blinded trial will assess kidney function at week 105, and Roche plans to share results with health authorities.
2. Licensing terms
The licensing agreement makes Ionis eligible for regulatory and sales milestone payments, as well as tiered royalties on sefaxersen net sales.
