SignalFDA/Bio
Ionis partner Roche announces new Phase 3 data showing sefaxersen significantly reduced proteinuria in people with IgA nephropathy (IgAN)
Roche's Phase 3 data show sefaxersen significantly reduced proteinuria in IgA nephropathy.
Context
What happened: Ionis partner Roche announced Phase 3 IMAgINATION data showing sefaxersen reduced proteinuria in adults with primary IgA nephropathy on optimized standard of care.
Key numbers: 43.1% reduction in proteinuria versus placebo at 37 weeks (95% CI: 32.5 to 52.0, P<0.0001); 459 patients enrolled, randomized 1:1 for 105 weeks; eGFR at week 105 to be evaluated.
Why it matters: Ionis CEO Brett Monia said the data support the belief that sefaxersen is uniquely positioned to treat IgAN. Roche will share data with health authorities.
Market: -2.6% today ($42.77), -46.3% YTD, 0.4x vol — as of 18:17 UTC
What changed
Ionis partner Roche announced Phase 3 IMAgINATION data showing sefaxersen reduced proteinuria in adults with primary IgA nephropathy on optimized standard of care.
Why it matters
Ionis CEO Brett Monia said the data support the belief that sefaxersen is uniquely positioned to treat IgAN. Roche will share data with health authorities.
Market: -2.6% today ($42.77), -46.3% YTD, 0.4x vol — as of 18:17 UTC