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news.Anthera Pharmaceuticals has begun the BRIGHT-SC Phase 2 IgA nephropathy study of an inhibitor of B-Cell Activating Factor (BAFF), blisibimod.
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Scheduled to enroll a minimum of 48 patients from Asia Pacific geographies, the multicenter, placebo-controlled, double-blind study will randomize the subjects into one active treatment arm or one placebo.
An interim analysis of proteinuria will be conducted in the study after an eight-week treatment.
The primary endpoint is reduction in proteinuria at week-32 whereas the secondary endpoints are 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 the FDA has accepted the use of proteinuria as a primary endpoint in studies of IgA nephropathy.
"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.