Biopharmaceutical company Anthera Pharmaceuticals has started the BRIGHT-SC Phase II study of an inhibitor of B-Cell Activating Factor (BAFF), blisibimod, to treat IgA nephropathy.
The multicentre, placebo-controlled, double-blind study will enrol a minimum of 48 patients from Asia Pacific geographies and randomise them into one active treatment arm or one placebo.
Following an eight-week treatment, an interim analysis of proteinuria is scheduled to be conducted as part of the study.
The study's primary endpoint is reduction in proteinuria at week-32, while the secondary endpoints include the effects of blisibimod on estimated Glomerular Filtration Rate (eGFR), plasma B cells, and other biomarkers of kidney disease.
Anthera regulatory affairs and compliance vice president Dr Paula Adams said that the use of proteinuria as a primary endpoint in studies of IgA nephropathy has been well-received by the FDA.
"Data from the BRIGHT-SC study design will be helpful in our efforts to obtain an accelerated approval for blisibimod in this potential orphan indication," Adams added.
A novel protein compromised of high-affinity BAFF binding domains fused to a human Fc domain, blisibimod is a broad inhibitor of BAFF and distinct from an antibody being explored for potential clinical use in autoimmune diseases.
Characterised by proteinuria and progression to end stage renal disease, IgA nephropathy is a chronic autoimmune renal disease.
Image: Immunostaining for IgA in a patient with Henoch-Schönlein nephritis. Photo courtesy of Lazarus Karamadoukis, Linmarie Ludeman and Anthony J Williams.