Anthera Announces the Completion of Patient Dosing in Phase 2b PEARL-SC Study
Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH) today announced the completion of dosing in the Company's Phase 2b PEARL-SC study. PEARL-SC (A randomized, double-blind Phase 2b study to evaluate the efficacy, safety, and tolerability of blisibimod administration in subjects with systemic lupus erythematosus) is examining the therapeutic benefit of monthly and weekly subcutaneous administration of blisibimod in systemic lupus erythematosus (SLE) patients.
The primary endpoint of the PEARL-SC study is clinical improvement at 24 weeks in an SLE responder index (SRI)-- a composite responder index evaluating various patient and physician reported clinical disease activity including a SELENA/SLEDAI* improvement of 5 points or greater, no increase in a physician's global assessment of more than 0.3 points, with no new BILAG A or two or more new BILAG B organ domain scores.
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