Anthera Pharmaceuticals Down 65% After Reporting Phase 2b PEARL-SC Clinical Study Results

Anthera Pharmaceuticals

is trading lower on the session after the company announced results from the Phase 2b PEARL-SC clinical study in patients with systemic lupus erythematosus. The 200mg weekly subcutaneous dose of blisibimod demonstrated a strong trend in improved clinical response as early as week 16 (p= 0.14), at the primary endpoint (p=0.15) and throughout week 44 including a statistically significant improvement at week 20 versus placebo (p=0.02). Paul F. Truex, Anthera's President and Chief Executive Officer said "The extensive data in the target severe population from our Phase 2 clinical program supports the initiation of a much smaller yet differentiated Phase 3 registration plan with the selected dose of blisibimod in patients with severe systemic lupus erythematosus. We have prospectively demonstrated for the first time the possibility for a subcutaneously administered BAFF inhibitor to be used in the treatment of a severe lupus population. The subgroup of severe patients from our Phase 2 study clearly identifies those patients most in need of therapy and most likely to benefit from our potent BAFF inhibitor blisibimod. Feedback from the EMA Scientific Advice process combined with an End of Phase 2 meeting in the third quarter will form the basis of our final phase 3 study designs." Anthera Pharmaceuticals is currently trading at $0.95, a loss of $1.80 or 65.43%.