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Anthera Updates Phase 3 Plans Following Results from the Phase 2b PEARL-SC Dose Ranging Study of Blisibimod
Date:6/27/2012

ients 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," said Paul F. Truex, Anthera's President and Chief Executive Officer. "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."

Table 1:  Response rates for 200mg weekly subcutaneous blisibimod versus placeboEndpoint (Subgroup)12 Week ResponsePlacebo / Active16 Week Response Placebo / Active 20 Week Response Placebo / Active24 Week Response Placebo / ActiveSRI-5

(mITT*)

27.1% / 29.3%

26.8% / 34.8%

31.6% / 44.6%

35.3% / 43.5%SRI-5

(Moderate*)

24.1% / 30.0%

29.3% / 36.0%

31.0% / 44.0%

34.5% / 48.0%SRI-5

(Severe*)

27.7% / 37.5%

34.0% / 41.7%

36.2% / 52.1%

40.4% / 54.2%* mITT:  Lupus, SELENA/SLEDAI >6, seropositive* Moderate Subgroup:  Lupus, SELENA/SLEDAI >8, seropositive, receiving steroids* Severe Subgroup:  Lupus, SELENA/SLEDAI >10, seropositive, receiving steroidsThe pre-specified primary efficacy endpoint, clinical improvement at 24 weeks in the SLE responder index for the pooled blisibimod dose groups, was not met due to a lack of clinical efficacy in the 100mg weekly and 200mg monthly dose groups.  All doses of blisibimod demonstrated consistent serological response including reductions of B-cells, ds-DNA and improvements in both complement C3 and C4.  Blisibimod was safe and well-tolerated at all dose levels with no meaningful imbalances in serious adverse events.  A single suicide attempt and a non-fatal single tuberculosis infection were seen in the placebo group.  There were seven deaths during the study - three in placebo and four blisibimod. 

Following a submission in April of 2012 the Company r
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SOURCE Anthera Pharmaceuticals
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