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news.Anthera Pharmaceuticals has completed patient dosing in the Phase IIb PEARL-SC study examining the therapeutic benefit of monthly and weekly subcutaneous administration of blisibimod in systemic lupus erythematosus (SLE) patients.
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The randomized, double-blind study will evaluate the efficacy, safety, and tolerability of blisibimod administration in subjects with systemic lupus erythematosus.
The clinical improvement at 24 weeks in an SLE responder index (SRI) is the primary endpoint of the study.
PEARL-SC will provide a sequence of key secondary subgroup and endpoint analyses which will help guide the design of Phase III registration studies and further differentiate blisibimod from currently available therapies.
The company plans to announce top-line data of the PEARL-SC study in the second quarter of 2012.