Lupus Nephritis

August 22, 2016

Aurinia Pharmaceuticals issued results of a phase IIb trial of voclosporin for active lupus nephritis (LN). The AURA–LV study enrolled 265 patients at centers in over 20 countries worldwide. Patients were randomized to one of two dosage groups of voclosporin (23.7mg BID and 39.5mg BID) or placebo, with all patients also receiving mycophenolate mofetil and oral corticosteroids as background therapy. All patients had an initial IV dose of steroids (500-1000mg) and then were started on 20-25mg/daily, which was tapered down to a low dose of 5mg daily by week eight and 2.5mg daily by week 16. The trial achieved its primary endpoint, demonstrating statistically significantly greater complete remission (CR) (as defined by confirmed urinary protein/creatinine ratio of =0.5mg/mg at 24 weeks and confirmed at 26 weeks) in patients treated with 23.7mg of voclosporin twice daily (p=0.045). Both treatment arms, 23.7mg and 35.9mg twice daily, also showed a statistically significant improvement in the rate of achieving partial remission at 24 weeks (p=0.007; p=0.024). No unexpected safety signals were observed and voclosporin was shown to be well-tolerated. Based on the results of the 24-week analysis, Aurinia plans to meet with the FDA in the fourth quarter of 2016 to discuss these data and the drug’s subsequent clinical development and path to registration in LN.

February 22, 2016

Aurinia Pharmaceuticals released results of an open label, single arm, exploratory study assessing the ability of biomarkers at eight weeks to predict clinical response rates at 24 and 48 weeks in subjects taking voclosporin 23.7mg twice daily in combination with standard-of-care, mycophenolate mofetil and corticosteroids, in patients with active lupus nephritis (LN). In the first seven patients that reached at least eight weeks of therapy in the AURION study, 100% (7/7) have achieved at least a 25% reduction in proteinuria compared to study entry. A 25% reduction in proteinuria has been shown to be predictive of a positive clinical response at 24weeks. All of the other pre-specified eight-week biomarkers of active LN have also improved and are trending towards normalization. These biomarkers have also been shown to be predictive of a positive clinical response at 24 weeks. In the first eight weeks of a 48 week regimen of multi-target therapy including voclosporin in AURION, an overall mean reduction of proteinuria of 72% compared to pre-treatment levels was observed, and 57% (4/7) of these patients achieved complete remission as defined by a urinary protein creatinine ratio of =0.5mg/mg. Overall renal function as measured by eGFR in these patients has remained stable.