LUPKYNIS (voclosporin) Achieved Significantly Higher Renal Response in Lupus Nephritis Patients with High Proteinuria Compared to Patients Treated with MMF and Low Dose Steroids Alone

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) today announced the results of a post-hoc, pooled analysis of the Phase 2 AURA-LV (NCT02141672) and Phase 3 AURORA 1 (NCT03021499) studies, which found that LUPKYNIS with mycophenolate mofetil (MMF) and low-dose steroids resulted in earlier and greater reductions in proteinuria in lupus nephritis (LN) patients with high proteinuria across biopsy classes, races, and ethnicities. These data were presented at the European Congress of Rheumatology, EULAR 2023, in Milan, Italy.

Consistent with results from the overall pooled study population, patients with urine protein creatinine ratio (UPCR) ≥2 g/g at baseline treated with LUPKYNIS achieved significantly higher renal response rates than patients treated with MMF and low-dose steroids alone, regardless of baseline demographics or clinical characteristics.

“Proteinuria is a common manifestation of LN that can lead to progressive kidney damage. Early reductions in UPCR have been shown to be predictive of improved long-term outcomes in LN. Yet, there remains the need for safe and effective therapies for patients with high proteinuria, especially given that monoclonal antibody therapies have demonstrated limited efficacy in LN patients with moderate to high proteinuria. These findings for voclosporin, a novel calcineurin inhibitor, are clinically relevant and can help improve renal outcomes for LN patients,” said lead study author Emily Littlejohn, D.O., M.P.H., Cleveland Clinic Main Campus, Rheumatologic and Immunologic Disease, Cleveland, Ohio.

“We are pleased to present these findings that further support the efficacy and safety of a voclosporin-based treatment regimen across diverse LN patient populations. In this analysis, complete response rates favored voclosporin regardless of sex, race, ethnicity, baseline UPCR or baseline renal function. Patients who achieved complete renal response with voclosporin experienced stable renal function while undergoing a rapid steroid taper as part of the study. These findings further differentiate LUPKYNIS, a next-generation CNI, from legacy, first-generation CNIs,” said Dr. Greg Keenan, Chief Medical Officer of Aurinia.