Roche reports positive Phase III interim results for sefaxersen in IgA nephropathy

Roche has reported positive prespecified interim results from the Phase III IMAgINATION study evaluating investigational sefaxersen in adults with primary IgA nephropathy, also known as IgAN.

The study met its primary endpoint, with sefaxersen producing a statistically significant and clinically meaningful reduction in proteinuria compared with placebo at week 37.

Proteinuria was assessed using 24 hour urine protein to creatinine ratio, or UPCR, which is an important indicator of kidney damage and is associated with long term kidney function.

Sefaxersen is designed to inhibit production of complement factor B at its main source in the liver. By targeting this component of the complement pathway, the treatment aims to block a key process involved in kidney damage associated with IgAN.

The investigational therapy is administered as a once monthly subcutaneous injection and has been designed to allow patients to self administer treatment.

Roche said the safety and tolerability profile observed in the interim analysis was consistent with previously reported findings, with no new safety signals identified.

Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development, said the interim findings demonstrate the potential for sefaxersen to improve an important surrogate measure of kidney function in people with IgAN.

He said the treatment could potentially help slow progression of the disease and reduce the longer term need for interventions including dialysis or kidney transplantation.

Bonnie Schneider, Director and Co Founder of the IgA Nephropathy Foundation, said the possibility of kidney failure and the need for dialysis or transplantation creates significant uncertainty for patients and their families.

She said the positive IMAgINATION results provide hope that new treatments may be able to preserve kidney function and change the future management of the disease.

The Phase III IMAgINATION study will continue under blinded conditions to assess longer term kidney function.

The trial will evaluate changes in estimated glomerular filtration rate, or eGFR, over two years, with the assessment scheduled for week 105.

Roche plans to present the interim data at an upcoming medical congress and share the findings with health authorities.

IgA nephropathy, also known as Berger’s disease, is a chronic and progressive autoimmune kidney condition.

The disease can ultimately lead to end stage kidney disease, with up to 50% of patients progressing to kidney failure within 20 years of diagnosis.

IgAN is commonly diagnosed before the age of 40 and affects at least 25 adults per million people worldwide each year.

It is the most common form of primary glomerulonephritis, which involves inflammation of the small filtering structures within the kidneys, and represents an important cause of chronic kidney disease and kidney failure.

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Related Topics and Keywords

autoimmune disease, clinical trials, IgAN, kidney disease, kidney health, nephrology, pharma news, proteinuria, Roche, sefaxersen