HAYWARD, CA, USA I June 24, 2013 I Anthera Pharmaceuticals, Inc. (ANTH), a biopharmaceutical company developing drugs to treat serious diseases associated with autoimmune disorders, today announced it has initiated the BRIGHT-SC Phase 2 study of blisibimod, a novel inhibitor of B-Cell Activating Factor (BAFF) for the treatment of IgA nephropathy. IgA nephropathy is a chronic autoimmune renal disease characterized by proteinuria and progression to end stage renal disease.
BRIGHT-SC is a multicenter, placebo-controlled, double-blind, Phase 2 clinical study that is expected to enroll at least 48 patients from Asia Pacific geographies. Patients will be randomized into one active treatment arm or one placebo arm. The primary endpoint of the study will be a reduction in proteinuria at 32 weeks. The Company plans to conduct an interim analysis of proteinuria after patients have completed 8 weeks of therapy. Secondary endpoints will include the effects of blisibimod on estimated Glomerular Filtration Rate (eGFR), plasma B cells, and other biomarkers of kidney disease.
In May, the company met with the US FDA to discuss the future of the IgA nephropathy development plan. “We are encouraged by the outcome of our pre-Investigational New Drug meeting with the FDA. The use of proteinuria as a primary endpoint in studies of IgA nephropathy was well received by the agency,” said Paula Adams, PhD, Anthera‘s Vice President of Regulatory Affairs and Compliance. “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.” In the coming weeks the Company will be meeting with the Japanese Pharmaceutical Medical Devices Agency to explore development strategies in Japan.
About B-Cell Activating Factor (BAFF) and Blisibimod
BAFF has been associated with a wide range of B-cell-mediated autoimmune diseases, including systemic lupus erythematosus, IgA nephropathy, lupus nephritis, rheumatoid arthritis, multiple sclerosis, Sjogren’s Syndrome, Graves’ Disease and others. Multiple clinical studies with other BAFF antagonists recently have reported on the potential positive role on BAFF inhibitors in treating lupus and rheumatoid arthritis with concomitant decreases in B-cells, plasma cells and autoantibodies. Anthera is advancing its development of blisibimod, a broad inhibitor of BAFF, to expand its potential clinical utility in autoimmune diseases. Blisibimod is a novel protein compromised of high-affinity BAFF binding domains fused to a human Fc domain, called a peptibody and is distinct from an antibody. Anthera owns worldwide rights to blisibimod in all potential indications.
About Anthera Pharmaceuticals
Anthera Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products to treat serious diseases associated with inflammation and autoimmune disorders.
SOURCE: Anthera Pharmaceuticals
Post Views: 193
HAYWARD, CA, USA I June 24, 2013 I Anthera Pharmaceuticals, Inc. (ANTH), a biopharmaceutical company developing drugs to treat serious diseases associated with autoimmune disorders, today announced it has initiated the BRIGHT-SC Phase 2 study of blisibimod, a novel inhibitor of B-Cell Activating Factor (BAFF) for the treatment of IgA nephropathy. IgA nephropathy is a chronic autoimmune renal disease characterized by proteinuria and progression to end stage renal disease.
BRIGHT-SC is a multicenter, placebo-controlled, double-blind, Phase 2 clinical study that is expected to enroll at least 48 patients from Asia Pacific geographies. Patients will be randomized into one active treatment arm or one placebo arm. The primary endpoint of the study will be a reduction in proteinuria at 32 weeks. The Company plans to conduct an interim analysis of proteinuria after patients have completed 8 weeks of therapy. Secondary endpoints will include the effects of blisibimod on estimated Glomerular Filtration Rate (eGFR), plasma B cells, and other biomarkers of kidney disease.
In May, the company met with the US FDA to discuss the future of the IgA nephropathy development plan. “We are encouraged by the outcome of our pre-Investigational New Drug meeting with the FDA. The use of proteinuria as a primary endpoint in studies of IgA nephropathy was well received by the agency,” said Paula Adams, PhD, Anthera‘s Vice President of Regulatory Affairs and Compliance. “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.” In the coming weeks the Company will be meeting with the Japanese Pharmaceutical Medical Devices Agency to explore development strategies in Japan.
About B-Cell Activating Factor (BAFF) and Blisibimod
BAFF has been associated with a wide range of B-cell-mediated autoimmune diseases, including systemic lupus erythematosus, IgA nephropathy, lupus nephritis, rheumatoid arthritis, multiple sclerosis, Sjogren’s Syndrome, Graves’ Disease and others. Multiple clinical studies with other BAFF antagonists recently have reported on the potential positive role on BAFF inhibitors in treating lupus and rheumatoid arthritis with concomitant decreases in B-cells, plasma cells and autoantibodies. Anthera is advancing its development of blisibimod, a broad inhibitor of BAFF, to expand its potential clinical utility in autoimmune diseases. Blisibimod is a novel protein compromised of high-affinity BAFF binding domains fused to a human Fc domain, called a peptibody and is distinct from an antibody. Anthera owns worldwide rights to blisibimod in all potential indications.
About Anthera Pharmaceuticals
Anthera Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products to treat serious diseases associated with inflammation and autoimmune disorders.
SOURCE: Anthera Pharmaceuticals
Post Views: 193
