The AURORA study investigated whether voclosporin, a novel calcineurin inhibitor, could reduce disease activity when added to background mycophenolate mofetil and low-dose corticosteroids in patients with active lupus nephritis (N=357). The primary end point of the study was complete renal response (defined as urinary protein-to-creatinine ratio [UPCR] of ≤0.5mg/mg, eGFR ≥60 mL/min/1.73 m2, or no confirmed decrease from baseline in eGFR of >20%, presence of sustained, low-dose steroids and no administration of rescue medication) at 52 weeks.
Results showed that renal response was achieved by 40.8% of voclosporin-treated patients compared with 22.5% of the placebo group (odds ratio: 2.65; P<.001). In addition, voclosporin was associated with statistically significant improvements in pre-specified hierarchical secondary end points including renal response at 24 weeks, partial renal response at 24 and 52 weeks, time to UPCR ≤0.5mg/mg and time to 50% reduction in UPCR.
With regard to safety, voclosporin was found to be well tolerated, and was not associated with significant decreases in estimated glomerular filtration rate or increases in blood pressure, lipids, or glucose at week 52. The most common serious adverse event reported in the trial was infection (10.1% with voclosporin vs 11.2% in the control arm).
“We are thrilled with the outcomes reported today from the AURORA trial, which unequivocally demonstrate the tremendous potential for voclosporin to play an important role in the treatment of the approximately one million people worldwide living with LN,” said Peter Greenleaf, President and Chief Executive Officer of Aurinia. “If approved, we look forward to potentially making voclosporin available to patients beginning in 2021.”
According to Aurinia, the developers of voclosporin, a New Drug Application (NDA) is expected to be submitted to the Food and Drug Administration in the first half of 2020.
For more information visit auriniapharma.com.
This article originally appeared on MPR