SOUTH SAN FRANCISCO (dpa-AFX) - Genentech, affiliated to Swiss drug major Roche Holding AG (RHHBY, RO.SW, ROG.SW), and partner Ionis Pharmaceuticals, Inc. (IONS) announced Wednesday positive prespecified interim results from the ongoing Phase III IMAgINATION study evaluating investigational sefaxersen in adults with primary IgA nephropathy or IgAN.
Roche licensed sefaxersen from Ionis for the treatment of complement mediated diseases.
IgAN, also known as Berger's disease, is a chronic and progressive autoimmune kidney disease, which is typically diagnosed in young adults. In the patients, up to 50% of people progress to kidney failure within 20 years, requiring dialysis or transplantation.
Proteinuria is a key indicator of kidney damage, and a reduction in UPCR is strongly associated with the preservation of long-term kidney function.
The companies said Sefaxersen inhibits complement factor B production at its primary source in the liver, thus blocking a key driver of IgAN-related kidney damage.
Sefaxersen is a once-monthly subcutaneous injection designed to enable self-administration for people with IgAN.
The trial 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.
The safety and tolerability profile of sefaxersen was consistent with previously reported data, with no new safety signals identified.
Levi Garraway, chief medical officer and head of Global Product Development, stated, '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. 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.'
Genentech said the IMAgINATION study will continue as a blinded study to evaluate the change in kidney function over two years, as measured by estimated glomerular filtration rate (eGFR) at week 105.
The company plans to present interim analysis data at an upcoming medical congress and to share with health authorities, aiming to bring the treatment to patients as soon as possible.
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