Interim analyses of blisibimod, conducted by an independent statistician once all ongoing patients had completed Week 24 and 48, demonstrated a consistent slowing of proteinuria progression and significant pharmacological effects on B cells and serum immunoglobulins. Patients, investigators, and the sponsor have remained blinded as to treatment assignment.
"We are encouraged by the trends on proteinuria seen in the interim analyses and look forward to the unblinded results from the BRIGHT-SC study," said
The study enrolled 57 patients, 42 of whom completed at least 60 weeks of evaluation and 21 of whom completed at least 104 weeks. Patients with persistent proteinuria (1-6 g/24hrs) despite background optimized therapy with angiotensin converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB), and estimated glomerular filtration rate > 30mL/min/1.73m2 were randomized to receive either blisibimod (300mg/wk for 8 weeks and 200mg/wk thereafter) or matching placebo for up to 104 weeks and were followed thereafter in the absence of study drug to assess longer term outcome. All patients were treated with an optimal dose of ACEi or ARB for a minimum of 90 days prior to randomization and this therapy was continued throughout the trial as background medication for all patients. Patients were not allowed to receive corticosteroids for the treatment of IgA nephropathy within 3 months of screening.
The BRIGHT-SC study was originally designed as a two-part Phase 2/3 study with a target enrollment of 200 patients. Part A was a 24-Week study of the effects of blisibimod on proteinuria, and Part B was an extension phase in which long term effects on the prevention of end stage renal disease would be assessed. After Week 24, patients had the option of continuing blinded treatment for up to two years, discontinuing treatment but continuing in the study under observation only, or discontinuing from the trial. The primary endpoint of the study was the number of patients who achieved a partial or complete response in urinary protein excretion at Week 24. A partial response was defined as achieving proteinuria ≤1g/24hrs, and a complete response as follows: for patients with baseline proteinuria ≥1g/24hrs but ≤2g/24hrs, achievement of proteinuria ≤1.0g/24hr AND a 50% reduction from baseline at 2 consecutive visits; for patients with baseline proteinuria > 2g/24hrs, achievement of proteinuria ≤1.0g/24hr OR a 50% reduction from baseline at 2 consecutive visits. Due to slow recruitment, enrollment was curtailed at 57 patients and the study was converted to a Phase 2 study. An observed case analysis was conducted when all patients had the opportunity to complete Week 24 and another at Week 48, and topline results were previously announced for both analyses. Mean effects by treatment group on proteinuria and certain measures of expected pharmacology (circulating B cells and B cell subpopulations, serum immunoglobulins) were analyzed and reported to Anthera by an independent statistician, with the treatment blind maintained for the patient, investigator, and sponsor personnel.
About IgA Nephropathy
IgA nephropathy (IgAN, also known as Berger's disease) is the most common cause of primary glomerulonephritis worldwide, occurring more frequently in
Blisibimod is a selective peptibody antagonist of the B-cell activating factor (BAFF) cytokine. BAFF is a tumor necrosis family member and is critical to the development, maintenance and survival of B-cells. It is primarily expressed by macrophages, monocytes and dendritic cells and interacts with three different receptors on B-cells including BAFF receptor, or BAFF-R, B-cell maturation, or BCMA, and transmembrane activator and cyclophilin ligand interactor, or TACI. The BAFF-R receptor is expressed primarily on peripheral B-cells. Blisibimod consists of a novel BAFF binding domain fused to the N-terminus of the Fc region of human antibody. Blisibimod binds to BAFF and inhibits the interaction of BAFF with its receptors.
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