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
"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
Anthera Pharmaceuticals, Inc