Bright • SC

The Phase 2 BRIGHT-SC study enrolled 57 patients with biopsy-proven IgAN, 42 of whom completed at least 60 weeks of evaluation and 21 of whom completed at least 104 weeks. Two interim analyses showed favorable trends as compared to placebo on the progression of proteinuria and expected pharmacological effects (reductions in circulating B cells and serum immunoglobulins). Dosing is now completed and study results are expected in Q3 2017. Patients with persistent proteinuria (1-6 g/24hrs), despite stable background optimized therapy with angiotensin converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB) for at least 90 days and estimated glomerular filtration rate >30mL/min/1.73m2, were randomized to receive either blisibimod (300mg/week for 8 weeks and 200mg/week thereafter) or matching placebo for up to 104 weeks and had the option of being followed thereafter in the absence of study drug to assess longer term outcome. ACEi or ARB was continued throughout the trial as background medication. Patients were not allowed to receive corticosteroids for the treatment of IgA nephropathy within 3 months of screening.

In the most recent interim analysis, the effects of blisibimod versus placebo were assessed through at least the 48 week time point in all patients. Patients 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 National Kidney Foundation. A positive trend on proteinuria by blisibimod was observed. Consistent with the previously announced Week 24 analysis, blisibimod treated-patients over time demonstrated stable to slightly decreased levels of proteinuria, 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.

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