The effects of blisibimod versus placebo were assessed through at least the 48 week time point in all patients in the BRIGHT-SC study. Patients enrolled in the BRIGHT-SC study had biopsy-proven IgA nephropathy with a mean proteinuria level of 2.4 grams and an estimated glomerular filtration rate of less than 70 mL/min/1.73m2 - indicative of stage 2 chronic kidney disease per the
A positive trend on proteinuria of blisibimod in patients with biopsy-proven IgA nephropathy was observed. Consistent with the previously announced Week 24 analysis, blisibimod treated-patients over time demonstrated stable to slightly decreasing levels of estimated 24 hour urinary protein excretion, as assessed by urinary protein to creatinine ratio (PCR), as compared to slowly increasing levels of proteinuria in the placebo group. 44 of the original 57 patients had a Week 48 observation and 22 patients had a Week 96 observation at the time of this analysis.
|Week||n||24 hour urinary protein |
excretion (grams; mean
|Week 48||Blisibimod||27||1.86 (1.04)|
|Week 96||Blisibimod||14||1.87 (0.79)|
Total B cell counts and serum immunoglobulins IgA, IgG, and IgM, continued to demonstrate marked reduction, consistent with data from the Week 24 analysis as well as other studies with blisibimod.
No safety or tolerability concerns were observed with blisibimod during routine reviews of the unblinded trial data by the study's independent Data and Safety Monitoring Board.
"The sustained effects of blisibimod versus placebo on proteinuria after up to 2 years of treatment are very encouraging for IgA nephropathy patients, for whom no treatments exist," said
Week 48 observations from the BRIGHT-SC study continue to demonstrate consistent pharmacological effects on B cells and serum immunoglobulins, and suggest an effect on proteinuria," said
The full dataset from this study will be submitted and presented at an upcoming scientific conference.
The study enrolled 57 patients, 44 of whom completed assessments through a minimum of 48 weeks. Patients with persistent proteinuria (1-6 g/24hrs) prior to enrollment were randomized to receive either blisibimod (300mg/wk for 8 weeks and 200mg/wk thereafter) or matching placebo over background angiotensin converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB) for up to 104 weeks and are 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. Steroid intervention was not permitted during the trial.
The BRIGHT-SC study was originally designed as a phase 2/3 study with a target enrollment of 200 patients with renal biopsy verified IgA nephropathy, 24 hour urine protein excretion of 1-6 grams by urinary protein to creatinine ratio (PCR), and an estimated glomerular
filtration rate (eGFR) of more than 30 ml/min/1.73 m2 of body surface area. The original 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 is 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 and the study was converted to phase 2. An observed case analysis was conducted when all patients had the opportunity to complete Week 24 and topline results
were previously announced. Based upon the Week 24 results, applications for Orphan Drug and Breakthrough Status have been filed with the
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
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Nikhil Agarwalof Anthera Pharmaceuticals, Inc., email@example.com or 510.856.5600 x5621
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