Roche and its partner Ionis Pharmaceuticals have announced positive interim data from their ongoing Phase III IMAgINATION clinical trial. The study is testing an investigational drug called sefaxersen in adults with primary IgA nephropathy (IgAN), a progressive kidney disease.

The trial successfully met its primary objective: at week 37, patients treated with sefaxersen showed a highly significant and meaningful reduction in excess urine protein (proteinuria) compared to those given a placebo. This improvement was tracked using a standard 24-hour urine protein-to-creatinine ratio (UPCR) test.

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.

“These interim phase III results show the clinical potential of sefaxersen to modify a key surrogate endpoint of kidney function in people with IgA nephropathy’’ said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “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.”

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