Ionis Pharmaceuticals and its partner, Roche, announced positive prespecified interim results from the ongoing Phase 3 IMAgINATION study for their investigational drug, sefaxersen, in adults with IgA nephropathy (IgAN), a progressive autoimmune kidney disease. The study successfully met its primary endpoint, demonstrating significant potential for the treatment.
Key Details
- Primary Endpoint Met: Sefaxersen achieved a statistically significant and clinically meaningful reduction in proteinuria (a key indicator of kidney damage) compared to placebo at 37 weeks.
- Next Steps: The study will continue as a blinded trial to evaluate kidney function over two years (at week 105). The interim data will be shared with health authorities to potentially accelerate availability.
- Partnership Terms: Sefaxersen is licensed to Roche. Ionis has received upfront and milestone payments and is eligible to receive additional regulatory and sales milestones, as well as tiered royalties on net sales.