Anthera Pharmaceuticals Inc (NASDAQ:ANTH) Gains 35% On Phase 3 Trial Update Print E-mail
By Josh Gee   
Tuesday, 10 February 2015 15:49

Shares of Anthera Pharmaceuticals Inc. (NASDAQ:ANTH) jumped a whopping 35% to $3.53 this afternoon on huge volume of 13.04 million shares – 20X its average volume as the company announced that its Phase 3 trial assessing blisibimod for the treatment of patients with systemic lupus erythematosus will continue to completion as planned. Patient enrollment should be finished by mid-year.

An independent statistician performed the interim futility analysis, evaluating the SRI-6 response at Week 24. The Systemic Lupus Erythematosus Response Index (SRI) is an endpoint recognized by the FDA for previously approved therapeutics.

Separately, the company completed a Scientific Advice Process meeting with the European Medicines Agency (EMA) regarding blisibimod for the treatment of IgA nephropathy (IgAN). The company received written feedback pertaining to the acceptability of a single pivotal study as the basis for a conditional market authorization application (MAA) for the E.U. utilizing proteinuria as the primary endpoint. It will, along with development partner Zenyaku Koygo Co., submit a protocol amendment incorporating all of the EMA's recommendations prior to the interim analysis later this quarter.

Blisibimod is a novel FC-fusion protein (peptibody) that selectively inhibits B-cell activating factor (BAFF). BAFF is a member of the tumor necrosis family which is essential for the development, maintenance and survival of B-cells. Abnormal levels of B-cells and BAFF can lead to an overactive immune response which can damage organs and tissues.




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