Roche Reports Positive Phase 3 Data For Sefaxersen In IgA Nephropathy
(RTTNews) - Roche (RHHBY) announced positive interim results from its ongoing Phase 3 IMAgINATION study evaluating investigational therapy sefaxersen in adults with primary IgA nephropathy, a progressive kidney disease that can eventually lead to kidney failure.
The company said the treatment significantly reduced proteinuria, a key marker of kidney damage, compared with placebo.
IgA nephropathy (IgAN), also known as Berger's disease, occurs when antibodies called immunoglobulin A accumulate in the kidneys, causing inflammation and gradual damage. The disease is often diagnosed in young adults, and up to half of patients may progress to kidney failure within 20 years, potentially requiring dialysis or a kidney transplant.
Sefaxersen is an investigational therapy designed to inhibit complement factor B production in the liver, targeting a key driver of kidney damage associated with IgAN. The treatment is administered as a once-monthly subcutaneous injection and is intended to be suitable for self-administration.
The findings were reported from Roche's Phase 3 IMAgINATION trial, which is evaluating the efficacy and safety of sefaxersen in adults with primary IgA nephropathy.
According to the company, the study met its primary endpoint, with sefaxersen demonstrating statistically significant and clinically meaningful reductions in proteinuria compared with placebo at 37 weeks, as measured by the 24-hour urine protein-to-creatinine ratio (UPCR). Roche noted that lower proteinuria levels are strongly associated with preservation of long-term kidney function.
The company said the results highlight the potential of sefaxersen to address a key indicator of kidney damage and support its development as a treatment option for people living with IgAN.
Safety and tolerability findings were consistent with previously reported data, and no new safety signals were identified during the interim analysis, according to Roche.
Roche licensed sefaxersen from Ionis Pharmaceuticals Inc. (IONS) under an agreement focused on the development and commercialization of treatments for complement-mediated diseases. Ionis remains eligible to receive milestone payments and royalties tied to the potential commercialization of the therapy.
The IMAgINATION study will continue in a blinded manner to assess changes in kidney function over a two-year period. Researchers will evaluate long-term kidney function using estimated glomerular filtration rate (eGFR) at week 105.
Roche said interim data from the study will be presented at an upcoming medical congress and submitted to health authorities as the company advances development of the therapy.
RHHBY has traded between $39.50 and $60.85 over the past year. The stock closed Wednesday's trading at $55.66, up 0.65%.
