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Anthera Pharmaceuticals Provides Additional Data from the Recently Completed PEARL-SC Study of Blisibimod in the Proposed Phase 3 Population
Date:7/16/2012

HAYWARD, Calif., July 16, 2012 /PRNewswire/ -- Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH), a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation and autoimmune disorders, today announced the final set of clinical data from the Phase 2b PEARL-SC study in patients with systemic lupus erythematosus. 

Final data from the PEARL-SC clinical study with 200mg weekly blisibimod suggest sustained and greater treatment effects versus placebo utilizing 6, 7, and 8-point improvements in the SELENA-SLEDAI disease-scoring index (Table 1).  In the predefined population of patients with severe disease who were also taking corticosteroids, the SRI-8 treatment benefit in the 200mg weekly blisibimod cohort was seen as early as week eight and achieved statistical significance starting at week 16 (35.4% blisibimod response versus 17.0% placebo response, p=0.04) through the 24 week endpoint (41.7% blisibimod response versus 10.4% placebo response, p<0.001).  

Additional data regarding time to first severe flare, total flares, proteinuria, and patients achieving a reduction of steroid dose below 7.5mg per day were also positive.  Amongst subjects treated with 200mg of blisibimod weekly, the mean time to first severe flare was 1.6-fold longer than subjects treated with placebo (348 days versus to 223 days).  The reduction in proteinuria at week 24 was significantly greater amongst subjects treated with blisibimod compared to placebo (35.0% versus 5.1%, p=0.045).  Further data from this recent analysis is available on the company's website at www.anthera.com.  Full data from the PEARL-SC study will be presented at an upcoming scientific conference.

"These results continue to validate the importance of phase 2 studies to identify the appropriate patient, dose and en
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SOURCE Anthera Pharmaceuticals, Inc.
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