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Anthera Initiates CHABLIS-SC1 Phase 3 Clinical Study in Lupus with Blisibimod
Date:3/27/2013

tudy is predicated on a prospective subgroup analysis conducted in the Phase 2b PEARL-SC study, which was reported in July 2012. In this analysis, a significant improvement in SRI-8 was observed in patients who received subcutaneous blisibimod (200mg QW) compared to those treated standard steroid therapy (N=95, 41.7% versus 10.4% respectively, p<0.001). This finding was corroborated by the separate analysis of SRI-8 responder rates conducted in the entire study population (N=547). The CHABLIS-SC1 study was reviewed by the US Food and Drug Administration as part of an "End of Phase 2" meeting in September 2012.

"The initiation of the CHABLIS-SC1 study marks a critical milestone for Anthera. The insight from our Phase 2b clinical study supports our belief that blisibimod may be a highly effective treatment option for the more severely ill lupus patients compared to currently available therapeutics," said Colin Hislop , MD, Anthera's Chief Medical Officer. "We are excited to advance blisibimod's development. Today we have taken another step towards making a much needed treatment available for this unpredictable and devastating disease."

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,
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SOURCE Anthera Pharmaceuticals, Inc.
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4. Anthera Updates Phase 3 Plans Following Results from the Phase 2b PEARL-SC Dose Ranging Study of Blisibimod
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11. Anthera Announces the Advancement of Blisibimod into Phase 3 Development for Patients with Systemic Lupus Erythematosus (SLE)
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