RNA-targeted medicine company Ionis Pharmaceuticals Inc (Nasdaq: IONS) and healthcare company Roche on Wednesday reported positive interim results from the Phase 3 IMAgINATION study of investigational sefaxersen in adults with primary IgA nephropathy (IgAN). The study met its primary endpoint, with sefaxersen producing statistically significant and clinically meaningful reductions in proteinuria versus placebo at 37 weeks.
The once-monthly subcutaneous treatment showed a safety and tolerability profile consistent with previous data, with no new safety signals identified. The study will continue in a blinded phase to assess kidney function at week 105.
Interim results will be presented at an upcoming medical congress and shared with health authorities. The study enrolled 459 patients at high risk of disease progression.
IgAN is a chronic, progressive autoimmune kidney disease typically diagnosed before age 40, with up to 50% of patients progressing to end-stage kidney disease within 20 years of diagnosis. Roche licensed sefaxersen from Ionis for complement-mediated diseases, with Ionis eligible for regulatory and sales milestones and tiered royalties on net sales.
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