Anthera Pharmaceuticals Announces Emerging Data from Phase 2 Open-Label Extension Study to be Presented at the ACR/ARHP 2013 Annual Scientific Meeting
HAYWARD, Calif., Sept. 25, 2013 /PRNewswire/ — Anthera Pharmaceuticals (NASDAQ: ANTH), a biopharmaceutical company focused on developing and commercializing products to treat autoimmune diseases, announced today that emerging data from its Phase 2b PEARL-SC study and subsequent Open-Label Extension study will be presented by Dr. Richard Furie at the 2013 Annual Scientific Meeting of the American College of Rheumatology and the Association of Rheumatology Health Professionals (ACR/ARHP).
Two abstracts, an oral presentation and a poster, will summarize interim findings from analyses of the Open-Label Extension study pertaining to the durability of effects of blisibimod over 52 weeks on renal biomarkers, including proteinuria and Complement C3, and serum immunoglobulins, including IgG and IgM.
The immunoglobulins IgG and IgA are thought to play a significant role in IgA nephropathy (IgAN). According to the Journal of Clinical Investigation, IgAN is characterized by immune complexes composed of galactose-deficient IgA1 (immunogenic IgA) and a glycan-specific IgG antibody that deposit in the kidneys.
“IgG and immunogenic IgA, when combined, form a complex that deposits in the kidney leading to a slow, insidious loss of kidney function,” said Dr. Jonathan Barratt, an IgA nephropathy specialist from the University of Leicester. “Any data that demonstrate a decrease in serum immunoglobulin levels provide further evidence for blisibimod’s potential effectiveness in treating patients with IgA nephropathy.”
“We’re very excited to be able to present data which provides additional insight into the role of blisibimod administration on immunoglobulin levels in patients with autoimmune diseases. They are a key component of what we discussed with the FDA and are exploring in the BRIGHT-SC clinical trial,” said Dr. Colin Hislop, Anthera’s Chief Medical Officer. “The pathology of IgA nephropathy is heavily centered on the abundance of these proteins.”
Oral Presentation: “Effects of Blisibimod, an Inhibitor of B Cell Activating Factor, on Serum Immunoglobulins and Infection Risk in Patients with Systemic Lupus Erythematosus: Observations from the Placebo-Controlled PEARL-SC and Open-Label Extension Studies”: Clinical Aspects and Treatment: Biologic Therapy (2:30PM-4:00PM, October 28(th))
Poster: “Effects of Chronic Treatment with Blisibimod, an Inhibitor of B Cell Activating Factor, on Renal and Inflammation Biomarkers in Patients with Systemic Lupus Erythematosus: Observations from the Placebo-Controlled PEARL-SC and Open-Label Extension Studies”: Clinical Aspects Poster II: Central Nervous System Manifestation (8:30AM – 4:00PM, October 28(th))
Anthera will be hosting a breakout session following the presentations by Dr. Furie. Please contact email@example.com for the event details.
About Blisibimod and PEARL-SC
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 fusion protein, or peptibody, and is distinct from an antibody. Anthera owns worldwide rights to blisibimod in all potential indications. BAFF, also known as BLyS (B lymphocyte stimulator), is a tumor necrosis family member and is critical to the development, maintenance and survival of B-cells. B-cells represent a critical component of human immune response to infection and other pathogens. However, abnormal elevations of B-cells and BAFF may lead to an overactive immune response which may 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 rheumatoid arthritis.
In April 2012, Anthera completed the PEARL-SC Phase 2b clinical study to evaluate the efficacy and safety of subcutaneous blisibimod in patients with active and seropositive lupus. In June and July of 2012 Anthera announced results from PEARL-SC which led to the initiation of a Phase 3 registration plan utilizing the 200mg weekly dose of blisibimod in patients who were afflicted with active lupus despite receiving corticosteroids.
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.
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CONTACT: Dennis Lutz of Anthera Pharmaceuticals, Inc., firstname.lastname@example.org or 510.856.5598.
SOURCE Anthera Pharmaceuticals, Inc.