A multicenter, placebo-controlled, double-blind Phase 2 clinical study, the BRIGHT-SC trial is anticipated to enroll a minimum of 48 patients from Asia Pacific geographies, who will then be randomized into one active treatment arm or one placebo arm. The study’s primary endpoint will be a reduction in proteinuria at 32 weeks. After the patients have completed eight weeks of therapy, Anthera intends to conduct an interim analysis of proteinuria. The study’s secondary endpoints will include the effects of blisibimod on estimated glomerular filtration rate (eGFR), plasma B cells and other kidney disease biomarkers.
Anthera met with the United States Food and Drug Administration (FDA) in May of this year to discuss the future of the IgA nephropathy development plan. The company has been encouraged by the outcome of its pre-Investigational New Drug meeting with the FDA, and the agency’s reception was positive regarding the use of proteinuria as a primary endpoint in studies of IgA nephropathy. The data from the BRIGHT-SC study design will aid Anthera in its efforts to obtain an accelerated approval for blisibimod in this potential orphan indication.
Anthera will meet with the Japanese Pharmaceutical Medical Devices Agency in the coming weeks to explore development strategies in Japan.
For more information, visit www.anthera.com
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