Ionis and Roche report positive Phase 3 interim data for sefaxersen in IgA nephropathy
The IMAgINATION study hit its primary endpoint at 37 weeks, with the trial continuing blinded to assess kidney function through week 105.
Ionis Pharmaceuticals and partner Roche announced on September 23, 2026 that the Phase 3 IMAgINATION study of investigational sefaxersen met its primary endpoint in adults with primary IgA nephropathy (IgAN). The study met its primary endpoint with sefaxersen achieving statistically significant and clinically meaningful improvements in proteinuria reduction, compared to placebo at 37 weeks, as measured by 24-hour urine protein-to-creatinine ratio (UPCR).1
Sefaxersen is a once-monthly subcutaneous injection designed to enable self-administration for people with IgAN, and its safety and tolerability profile was consistent with previously reported data, with no new safety signals identified.1
The trial design calls for continued blinded follow-up. The IMAgINATION study will continue as a blinded study to evaluate the change in kidney function over two years, as measured by estimated glomerular filtration rate (eGFR) at week 105.1 Interim analysis data will be presented at an upcoming medical congress and shared with health authorities, with the goal of bringing this treatment to patients as soon as possible, the company said.1
Study details: IMAgINATION (NCT05797610) is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluating subcutaneous sefaxersen in patients with primary IgA nephropathy at high risk of progression, and enrolled 459 people randomized 1:1 to sefaxersen or placebo for 105 weeks.1
On the commercial arrangement, Roche licensed sefaxersen from Ionis for the treatment of complement-mediated diseases, with Ionis receiving an upfront payment, license fee and development milestone payments, and eligibility for regulatory and sales milestone payments plus tiered royalties on net sales.1
Regarding the disease itself, IgAN, also known as Berger's disease, is a chronic and progressive autoimmune disease that leads to end-stage kidney disease in up to 50% of patients within 20 years after diagnosis, and is typically diagnosed before age 40, affecting at least 25 adults per million worldwide each year.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.