Anthera initiates PEARL-SC Phase 2b study of A-623 for lupus

Jul 30 2010

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.

"This improved PEARL-SC study represents a significant advancement in the study of A-623 for patients with lupus.  We were pleased the FDA has endorsed a more meaningful study targeting a clinical endpoint which incorporates the latest knowledge of B-Cell modulation and potential impact on the various aspects of lupus," stated Paul Truex, Anthera's President and Chief Executive Officer.

"Recent clinical studies have provided hope that the treatment of lupus with BLyS inhibition can be significantly improved over currently available treatment options.  The PEARL-SC study design includes insights from our Scientific Advisory Board and will provide more meaningful information about the potential of A-623 in lupus patients," stated Colin Hislop, M.D., Anthera's Chief Medical Officer. "By inhibiting both soluble and membrane bound forms of BAFF, A-623 could provide an additional therapeutic benefit in lupus with the convenience of subcutaneous dosing."

SOURCE Anthera Pharmaceuticals, Inc.