The PEARL-SC clinical trial testing investigational lupus treatment blisibimod is moving forward as planned per a complete analysis of interim safety and effectiveness data. The trial is sponsored by Anthera Pharmaceuticals, Inc. a biopharmaceutical company developing drugs to treat serious diseases including cardiovascular and autoimmune disorders.
As a result of these recommendations, top-line efficacy data from the PEARL-SC clinical study is expected in the second quarter of 2012. With 547 patients the study retains greater than 90% statistical power to detect a treatment difference of 14% with an associated p-value of less than 0.046 (p<0.046) for the study's primary endpoint*.
The PEARL-SC randomized, double-blind Phase 2b study enrolled 547 patients in 11 countries and 72 clinical sites worldwide.