Roche has reported positive prespecified interim results from the ongoing phase III IMAgINATION study evaluating investigational sefaxersen in adults with primary IgA nephropathy (IgAN).
The study met its primary endpoint, with sefaxersen demonstrating statistically significant and clinically meaningful reductions in proteinuria compared with placebo at week 37, as measured by the 24-hour urine protein-to-creatinine ratio (UPCR).
Proteinuria is an indicator of kidney damage, while a reduction in UPCR is associated with preservation of long-term kidney function.
IgA nephropathy, also known as Berger’s disease, is a chronic and progressive autoimmune disease that can lead to end-stage kidney disease. 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 and kidney failure.
Sefaxersen is described as the first mRNA-targeted therapy for IgA nephropathy. It is an investigational, liver-directed antisense oligonucleotide designed to inhibit the production of complement factor B. Elevated levels of serum complement factor B have been observed in people with IgAN. Reducing these levels leads to a reduction in the level of protein in urine, which is a key indicator of improved kidney function.
The company noted that sefaxersen is designed to provide sustained control of the alternative complement pathway, which plays an important role in the disease
The therapy is being developed as a once-monthly subcutaneous injection intended for self-administration. Roche licensed sefaxersen from Ionis Pharmaceuticals for the treatment of complement-mediated diseases.
“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, Chief Medical Officer and Head of Global Product Development at Roche.
Garraway added that sefaxersen could potentially offer a new treatment option aimed at slowing disease progression and reducing the long-term need for dialysis or kidney transplantation.
The IMAgINATION study will continue as a blinded study to assess changes in kidney function over two years, with estimated glomerular filtration rate (eGFR) at week 105 serving as the measure. Roche said interim analysis data will be presented at an upcoming medical congress and shared with health authorities.
Roche Proposes Former Takeda CEO Christophe Weber for Board
Separately, Roche announced that its Board of Directors has approved the proposal of Dr Christophe Weber, former CEO of Takeda Pharmaceuticals, for election to Roche’s Board of Directors at the company’s Annual General Meeting on March 9, 2027.
Roche Chairman Severin Schwan said Weber’s healthcare industry knowledge and leadership experience would further strengthen the company’s Board.
Weber stepped down as CEO of Takeda Pharmaceuticals in June 2025 after more than 10 years leading the Japanese drugmaker.
