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Anthera's blisibimod flunks late-stage lupus study; shares down 15% premarket

Published 11/10/2016, 08:44 AM
Anthera's blisibimod flunks late-stage lupus study; shares down 15% premarket
ANTH
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  • Micro cap Anthera Pharmaceuticals (NASDAQ:ANTH) slumps 15% premarket on robust volume in response to its announcement that a Phase 3 clinical trial, CHABLIS-SC1, assessing blisibimod for the treatment of patients with active systemic lupus erythematosus (SLE) failed to achieve its primary endpoint.
  • The responder rate favored blisibimod over placebo, 47% vs. 42%, but fell short of statistical significance, due to what appears to be an unusually high response rate for placebo. The primary endpoint was the response rate at Week 52 measured by a composite index called the SLE Responder Index-6 (SRI-6). The magnitude of the treatment effect for blisibimod as measured by other indices, SRI-4 and SRI-8, also fell short of statistical significance.
  • Blisibimod is a selective peptibody antagonist of the B-cell activating factor (BAFF) cytokine, a member of the tumor necrosis family that is critical to the development, maintenance and survival of B-cells. It binds to BAFF and inhibits the interaction of BAFF with its receptors thereby reducing the number of B-cells and mitigating the immune response.
  • The company says it will continue analyzing the data and will consult with SLE opinion leaders before deciding whether to proceed with the lupus program. The ongoing Phase 3 CHABLIS 7.5 will continue for the time being. Its program in IgA nephropathy will continue as well. Data from two studies, Phase 2 BRIGHT-SC IgAN and Phase 3 Sollpura SOLUTION, are expected later this quarter.

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