Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH), a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation, today announced positive interim biomarker data from the PEARL-SC phase 2b clinical study in patients with systemic lupus erythematosus.
After analysis by an independent statistician, data from the on-going PEARL-SC study indicate that weekly and monthly subcutaneous doses of blisibimod resulted in statistically significant reductions of B-cells. Elevations in these B-cells have been associated with an increased risk of disease activity in lupus patients. These findings are consistent with data from previous clinical studies of blisibimod. The company remains blinded to primary efficacy data.
"We believe reductions of B-cells in the PEARL-SC study will correlate to a reduction in disease activity in patients treated with blisibimod," said Colin Hislop, MD, Chief Medical Officer and Senior Vice President of Anthera Pharmaceuticals. "This analysis demonstrates that the selected weekly and monthly blisibimod doses resulted in an appropriate biological response. If confirmed with positive clinical outcomes from the PEARL-SC study, these data will provide guidance for the design of our phase 3 clinical studies and allow us to differentiate blisibimod from other available BAFF inhibitors for the treatment of lupus."
Final results from the PEARL-SC clinical study are expected in the second quarter of 2012. A proposed amendment to PEARL-SC also includes an option for an interim efficacy analysis to be conducted by an independent statistician after the 350th enrolled subject has reached 24 weeks in the study -- the primary efficacy time point.
Microbial biomarkers identified in lupus and IBD offer pathways for targeted therapies