Anthera Pharma spikes 30% on continuation of lupus study

• Thinly-traded nano cap Anthera Pharmaceuticals (OTC:ANTH +31.2%) jumps on a whopping 14x surge in volume in response to the company's announcement 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.