Anthera Pharmaceuticals Announces Completion of Interim Analysis from Phase 3 Trial with Blisibimod for IgA Nephropathy

-BRIGHT-SC study passes futility analysis and will continue to completion

-Primary efficacy analysis data expected in second half of 2016

-Feedback from European Medicines Agency incorporated into final study design

16 Mar, 2015, 08:44 ET from Anthera Pharmaceuticals, Inc.

HAYWARD, Calif., March 16, 2015 /PRNewswire/ -- Anthera Pharmaceuticals, Inc. (NASDAQ: ANTH), in collaboration with its partner Zenyaku Kogyo Co., Ltd. today announced that the BRIGHT-SC study of blisibimod in patients with IgA nephropathy (IgAN) should continue to completion as planned. This follows the successful completion of an interim futility analysis, conducted by an independent statistician, which evaluated several important biomarkers of renal disease in patients who had completed at least 8 weeks of treatment.

"IgAN is a disease that carries significant long-term morbidity. As there are no approved treatments to address its root cause, rather than just its symptoms, we are glad to have passed this important milestone  and taken a step closer to bringing this drug to patients with IgAN," said Dr. Colin M. Hislop, Anthera's Chief Medical Officer.

As previously disclosed, following meetings with the European Medicines Agency, the Japanese PMDA, the US FDA, and our partner Zenyaku Kogyo, the company amended the BRIGHT-SC protocol prior to the interim analysis to reflect collective feedback.  All agencies were receptive to the use of proteinuria as a surrogate endpoint with appropriate post-marketing studies.

About Anthera Pharmaceuticals

Anthera Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products to treat serious and life-threatening diseases, including systemic lupus erythematosus, IgA nephropathy, and exocrine pancreatic insufficiency due to cystic fibrosis.

About Blisibimod

Anthera is developing blisibimod, a selective inhibitor of B-cell activating factor (BAFF), to explore its clinical utility in various autoimmune diseases including systemic lupus erythematosus (SLE) and IgA nephropathy. Blisibimod is a novel FC-fusion protein, or peptibody, and is distinct from an antibody. BAFF is a tumor necrosis family member and is critical to the development, maintenance and survival of B-cells. Abnormal elevations of B-cells and BAFF may lead to an overactive immune response, which can damage normal healthy tissues and organ systems. Multiple clinical studies with BAFF antagonists have reported the potential benefit of BAFF inhibitors in treating patients with lupus and IgAN.

About Sollpura (liprotamase)

Sollpura is a soluble, stable and non-porcine enzyme product intended for the treatment of patients with Exocrine Pancreatic Insufficiency (EPI) due to cystic fibrosis, and potentially other diseases. EPI is characterized by low absorption of fat and other nutrients due to a reduction in digestive enzymes produced by the pancreas.  Unlike other enzyme products for EPI, Sollpura's chemical characteristics make it ideal for formulation as either a capsule or sachet product for co-administration with a variety of food products.

Safe Harbor Statement

Any statements contained in this press release that refer to future events or other non-historical matters, including statements that are preceded by, followed by, or that include such words as "estimate," "intend," "anticipate," "believe," "plan," "goal," "expect," "project," or similar statements, are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on Anthera's expectations as of the date of this press release and are subject to certain risks and uncertainties that could cause actual results to differ materially as set forth in Anthera's public filings with the SEC, including Anthera's Annual Report on Form 10-K for the year ended December 31, 2014.  Anthera disclaims any intent or obligation to update any forward-looking statements, whether because of new information, future events or otherwise, except as required by applicable law.

CONTACT: Dennis Lutz of Anthera Pharmaceuticals, Inc., dlutz@anthera.com or 510.856.5598.

 

SOURCE Anthera Pharmaceuticals, Inc.



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