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Anthera Updates Phase 3 Plans Following Results from the Phase 2b PEARL-SC Dose Ranging Study of Blisibimod
Date:6/27/2012

HAYWARD, Calif., June 27, 2012 /PRNewswire/ -- Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH), a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation and autoimmune disorders, today announced results from the Phase 2b PEARL-SC clinical study in patients with systemic lupus erythematosus.The purpose of the PEARL-SC study was to identify an effective and safe dose for future phase 3 clinical studies and explore key inclusion criteria and clinical endpoints in an effort to maximize differentiation of blisibimod from currently available therapies.  The 200mg weekly subcutaneous dose of blisibimod demonstrated a strong trend in improved clinical response as early as week 16 (p= 0.14), at the primary endpoint (p=0.15) and throughout week 44 including a statistically significant improvement at week 20 versus placebo (p=0.02).

In a predefined phase 3 target population of severely ill, seropositive lupus patients, defined as SELENA-SLEDAI ≥10 and receiving background corticosteroid medication, a more pronounced effect was seen in the 200mg weekly dose group demonstrating a 13.8% treatment difference compared to placebo at 24 weeks.  In this subgroup, planned for phase 3 studies, separation of clinical response occurred as early as week 8 and was also sustained through week 44.  Results from the 200mg weekly group are presented in Table 1.

"The extensive data in the target severe population from our Phase 2 clinical program supports the initiation of a much smaller yet differentiated Phase 3 registration plan with the selected dose of blisibimod in patients with severe systemic lupus erythematosus.  We have prospectively demonstrated for the first time the possibility for a subcutaneously administered BAFF inhibitor to be used in the treatment of a severe lupus population.  The subgroup of severe pat
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SOURCE Anthera Pharmaceuticals
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