Anthera Pharmaceuticals, Inc. Announces Top Line Final Data from Phase 2 BRIGHT-SC Study of Blisibimod
August 28, 2017 at 10:23 am EDT
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Anthera Pharmaceuticals, Inc. announced top line final data from the extension of the randomized, double-blind, placebo controlled, Phase 2 BRIGHT-SC study of blisibimod in 58 patients with IgA nephropathy (IgAN). Patients were treated for up to 2 years, and all patients had the opportunity to complete at least 60 weeks of treatment. Throughout the treatment period and for up to one year of additional follow up off treatment, blisibimod appeared to halt disease progression as measured by the mean estimate of 24-hour urinary protein excretion levels, also known as proteinuria. Specifically, in patients treated with blisibimod, the mean change in proteinuria was stable to trending slightly downward, whereas the mean levels increased for patients in the placebo arm. Additionally, blisibimod demonstrated a trend toward preservation of renal function based upon individual rates of change in estimated glomerular filtration rate (eGFR), with an annualized improvement of +6.2mL/min/1.73 m per year compared to a worsening of -4.8 mL/min/1.73 m of body surface area with placebo. As seen with previous interim analyses of the BRIGHT data, serum immunoglobulins IgA, IgG, and IgM, continue to demonstrate marked reduction throughout the treatment period. Blisibimod was well tolerated with substantially more patients on the placebo arm discontinuing from the study than those receiving blisibimod. The most common adverse events seen in the blisibimod group over the entire study period were upper respiratory infection, nasopharyngitis, and injection site reactions. There were no incidences of serious infection in the blisibimod group and the overall rates of infection were similar in the two treatment groups.
Anthera Pharmaceuticals, Inc. (Anthera) is a biopharmaceutical company focused on developing and commercializing products to treat serious diseases associated with inflammation, including enzyme replacement therapies and autoimmune diseases. The Company has two Phase III product candidates, liprotamase also known as Sollpura and blisibimod. Sollpura is a non-porcine investigational Pancreatic Enzyme Replacement Therapy (PERT) intended for the treatment of patients with Exocrine Pancreatic Insufficiency (EPI), often seen in patients with cystic fibrosis and other conditions. Blisibimod targets B-cell activating factor (BAFF), which has been shown to be elevated in a range of B-cell mediated autoimmune diseases, including systemic lupus erythematosus (SLE), or lupus, Immunoglobulin A nephropathy (IgA) nephropathy, lupus nephritis and others.