Positive preliminary findings have been reported from the AURION (Aurinia Early Urinary Protein ReductION Predicts Response) study of voclosporin (Aurinia Pharmaceuticals) in patients with lupus nephritis. All of the first seven patients who had reached at least eight weeks of therapy achieved at least a 25% reduction in proteinuria compared with study entry. A 25% reduction in proteinuria has been shown to predict a positive clinical response at 24 weeks.
Voclosporin is an investigational calcineurin inhibitor (CNI) made by modifying a single amino acid of the cyclosporine molecule (a CNI approved for use in transplant patients since 1983).
In the first eight weeks of a 48-week regimen of multitargeted therapy, including voclosporin, the investigators observed an overall mean reduction in proteinuria of 72% compared with pretreatment levels, and 57% (4/7) of these patients achieved complete remission. Overall renal function in these patients, as measured by the estimated glomerular filtration rate, remained stable.
The AURION trial is an open-label, single-arm, exploratory study evaluating the ability of biomarkers at eight weeks to predict clinical response rates at 24 and 48 weeks in subjects treated with voclosporin 23.7 mg twice daily in combination with standard of care (mycophenolate mofetil and corticosteroids) in patients with active lupus nephritis.
Source: Aurinia Pharmaceuticals; February 8, 2016.