Anthera announces final set of clinical data from blisibimod Phase 2b study on SLE

Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH), a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation and autoimmune disorders, today announced the final set of clinical data from the Phase 2b PEARL-SC study in patients with systemic lupus erythematosus.

Final data from the PEARL-SC clinical study with 200mg weekly blisibimod suggest sustained and greater treatment effects versus placebo utilizing 6, 7, and 8-point improvements in the SELENA-SLEDAI disease-scoring index. In the predefined population of patients with severe disease who were also taking corticosteroids, the SRI-8 treatment benefit in the 200mg weekly blisibimod cohort was seen as early as week eight and achieved statistical significance starting at week 16 (35.4% blisibimod response versus 17.0% placebo response, p=0.04) through the 24 week endpoint (41.7% blisibimod response versus 10.4% placebo response, p<0.001).

Additional data regarding time to first severe flare, total flares, proteinuria, and patients achieving a reduction of steroid dose below 7.5mg per day were also positive. Amongst subjects treated with 200mg of blisibimod weekly, the mean time to first severe flare was 1.6-fold longer than subjects treated with placebo (348 days versus to 223 days). The reduction in proteinuria at week 24 was significantly greater amongst subjects treated with blisibimod compared to placebo (35.0% versus 5.1%,s website at www.anthera.com. Full data from the PEARL-SC study will be presented at an upcoming scientific conference.

"These results continue to validate the importance of phase 2 studies to identify the appropriate patient, dose and endpoint in order to optimize our phase 3 study design. Specifically, the PEARL-SC SRI response using larger improvements in SELENA-SLEDAI appear substantially better than the SRI-5 data. In fact, the SRI-8 data, representing an improvement in SELENA-SLEDAI of eight points or greater achieves statistical significance at multiple time points including at 24 weeks. Due to the consistently better effects at higher thresholds, it appears that if a blisibimod patient responds, they respond very well," said Colin Hislop, MD, Anthera's Senior Vice President and Chief Medical Officer. "As well, additional clinical data suggest positive trends in time to severe flare, flare rates, proteinuria, and steroid utilization."