Anthera Announces Initiation of BRIGHT-SC Phase 2 Clinical Study in IgA Nephropathy with Blisibimod
HAYWARD, Calif., June 24, 2013 /PRNewswire/ -- Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH), a biopharmaceutical company developing drugs to treat serious diseases associated with autoimmune disorders, today announced it has initiated the BRIGHT-SC Phase 2 study of blisibimod, a novel inhibitor of B-Cell Activating Factor (BAFF) for the treatment of IgA nephropathy. IgA nephropathy is a chronic autoimmune renal disease characterized by proteinuria and progression to end stage renal disease.
BRIGHT-SC is a multicenter, placebo-controlled, double-blind, Phase 2 clinical study that is expected to enroll at least 48 patients from Asia Pacific geographies. Patients will be randomized into one active treatment arm or one placebo arm. The primary endpoint of the study will be a reduction in proteinuria at 32 weeks. The Company plans to conduct an interim analysis of proteinuria after patients have completed 8 weeks of therapy. Secondary endpoints will include the effects of blisibimod on estimated Glomerular Filtration Rate (eGFR), plasma B cells, and other biomarkers of kidney disease.
In May, the company met with the US FDA to discuss the future of the IgA nephropathy development plan. "We are encouraged by the outcome of our pre-Investigational New Drug meeting with the FDA. The use of proteinuria as a primary endpoint in studies of IgA nephropathy was well received by the agency," said Paula Adams, PhD, Anthera's Vice President of Regulatory Affairs and Compliance. "Data from the BRIGHT-SC study design will be helpful in our efforts to obtain an accelerated approval for blisibimod in this potential orphan indication." In the coming weeks the Company will be meeting with the Japanese Pharmaceutical Medical Devices Agency to explore development strategies in Japan.
About B-Cell Activating Factor (BAFF) and Blisibimod
BAFF has been associated with a wide range of B-cell-mediated autoimmune diseases, including systemic lupus erythematosus, IgA nephropathy, lupus nephritis, rheumatoid arthritis, multiple sclerosis, Sjogren's Syndrome, Graves' Disease and others. Multiple clinical studies with other BAFF antagonists recently have reported on the potential positive role on BAFF inhibitors in treating lupus and rheumatoid arthritis with concomitant decreases in B-cells, plasma cells and autoantibodies. Anthera is advancing its development of blisibimod, a broad inhibitor of BAFF, to expand its potential clinical utility in autoimmune diseases. Blisibimod is a novel protein compromised of high-affinity BAFF binding domains fused to a human Fc domain, called a peptibody and is distinct from an antibody. Anthera owns worldwide rights to blisibimod in all potential indications.
About Anthera Pharmaceuticals
Anthera Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products to treat serious diseases associated with inflammation and autoimmune disorders.
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 include statements about the Company's expectations with respect to its proposed offering, including its intention to offer and sell shares, its intention to grant the underwriters an option to purchase additional shares and its intended use of proceeds from the offering. Such statements are based on the Company'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, including but not limited to the risks and uncertainties associated with market conditions and the satisfaction of customary closing conditions related to the proposed offering, as well as those set forth in the Company's public filings with the SEC, including the Company's Annual Report on Form 10-K for the year ended December 31, 2012 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2013. The Company 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., email@example.com or (510)856-5598.
SOURCE Anthera Pharmaceuticals, Inc.
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