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.

"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

Add this page to your favorite Social Bookmarking websites
Digg! Reddit!! Mixx! Google! Live! Facebook! Technorati! StumbleUpon! MySpace! Yahoo!