Anthera Announces Initiation of BRIGHT-SC Phase 2 Clinical Study in IgA
Nephropathy with Blisibimod
HAYWARD, Calif., June 24, 2013
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
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
SOURCE Anthera Pharmaceuticals, Inc.
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