Nov. 13, 2012
/PRNewswire/ -- Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH), a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation and autoimmune disorders, today announced additional data from its Phase 2b PEARL-SC study presented in a late breaking poster at the 2012 Annual Scientific Meeting of the American College of Rheumatology and the Association of Rheumatology Health Professionals (ACR/ARHP). The poster entitled "Blisibimod, an Inhibitor of B cell Activating Factor, in Patients with Moderate-to-Severe Systemic Lupus Erythematosus," was presented by Dr.
, MD, on
Tuesday, November 13, 2012
. Dr. Furie is Chief of the Division of Rheumatology and Allergy-Clinical Immunology at the North Shore-Long Island Jewish Health System and directs the hospital's Systemic Lupus Erythematosus (SLE) and Autoimmune Disease Treatment Center.
The poster highlights data from the PEARL-SC clinical study including new information regarding treatment effects in the broader modified intent to treat population of lupus patients where 200 mg weekly blisibimod therapy was associated with statistically significant benefits in predefined SLE Responder Index (SRI*) endpoints. Specifically, this new data indicates statistically significant treatment effects using higher thresholds of improvement in disease score (SELENA/SLEDAI** reductions of 7 and 8) including the recently FDA reviewed SRI-8 endpoint to be utilized in the phase 3 CHABLIS-SC clinical studies. These data confirm and expand on previously reported clinical improvements seen in the population of patients to be enrolled in the CHABLIS-SC phase 3 clinical studies. These studies will enroll patients with active disease (SELENA/SLEDAI
10) who are also receiving corticosteroid therapy at baseline.
As well, the poster highlighted the positive effects of blisibimod on markers of renal disease including proteinuria and antibodies to double stranded DNA.
"PEARL-SC provided a great deal of insight into the treatment effect of blisibimod in patients who continue to have overt clinical manifestations of their disease, such as a rash and joint pain, despite the addition of corticosteroid therapy," said Dr. Furie.