Roche has announced positive prespecified interim results from the ongoing phase 3 IMAgINATION study evaluating investigational sefaxersen 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).

Proteinuria is a key indicator of kidney damage and a reduction in UPCR is strongly associated with the preservation of long-term kidney function. Sefaxersen is a once-monthly subcutaneous injection designed to enable self-administration for people with IgAN. The safety and tolerability profile of sefaxersen was consistent with previously reported data, with no new safety signals identified.

Levi Garraway, MD, PhD, Chief Medical Officer and Head of Global Product Development, Roche, said, “These interim phase 3 results show the clinical potential of sefaxersen to modify a key surrogate endpoint of kidney function in people with IgA nephropathy. Sefaxersen may therefore offer a new treatment option to help slow disease progression and potentially reduce the long-term need for dialysis or kidney transplantation.”

The IMAgINATION study will continue as a blinded study to evaluate the change in kidney function over 2 years, as measured by estimated Glomerular Filtration Rate (eGFR) at week 105. 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.

Bonnie Schneider, Director and Co-Founder, IgA Nephropathy Foundation, said, “For patients and families navigating IgAN, the prospect of kidney failure, dialysis, or transplantation creates overwhelming uncertainty. As someone who has advocated for this community for over 2 decades, positive results from the IMAgINATION study give us hope that emerging therapies could help preserve kidney function and transform the treatment landscape.”

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 percent of patients within 20 years of diagnosis. Typically diagnosed before the age of 40 years, it affects at least 25 adults per million worldwide each year. It is the most common form of primary glomerulonephritis (inflammation of the tiny filters, glomeruli, in the kidneys) and is a major cause of Chronic Kidney Disease (CKD) as well as kidney failure.