Roche reported positive interim results from its Phase III IMAgINATION study for sefaxersen. The trial evaluated the investigational drug in patients with IgA nephropathy (IgAN), a chronic autoimmune kidney disease. Sefaxersen met its primary endpoint by achieving a statistically significant reduction in proteinuria compared to a placebo at 37 weeks.
Roche licensed the RNA-targeted therapy from Ionis Pharmaceuticals. The drug inhibits the production of complement factor B to limit kidney damage. Patients receive the treatment via a monthly subcutaneous injection.
The safety profile remained consistent with previous studies. Roche will present these findings at an upcoming medical meeting. The company plans to discuss the data with health authorities to pursue a potential accelerated approval pathway.