Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH), a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation, today announced it has initiated PEARL-SC, the Phase 2b study of A-623, a novel inhibitor of B-Cell Activating Factor, or BAFF, for the treatment of Systemic Lupus Erythematosus (lupus). Lupus patients suffer from a chronic autoimmune disease, which often leads to severe skin rash, fatigue, joint pain, major organ complications, and cardiovascular disease.
PEARL-SC is a, randomized, double-blind, placebo-controlled, Phase 2b clinical study that will enroll up to 600 patients in up to 60 centers worldwide. Patients will be randomized into three active treatment arms and one placebo treatment arm for a minimum of 24 weeks. The primary endpoint of the PEARL-SC study is clinical improvement at 24 weeks in the systemic lupus erythematosus (SLE) responder index, a recently recognized FDA endpoint for demonstrating clinical efficacy. The SLE rates from the treated group will be pooled and compared to those from the placebo group. Secondary endpoints will include safety, improvement in other clinical assessment scores, patient response versus baseline disease severities, resolution of fatigue, steroid utilization, and time to flare. As previously announced, a blinded interim biomarker analysis will be conducted early in the study to establish the appropriate drug effect on B-Cells and potentially remove any arm that is not demonstrating a biologic effect.