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Aurinia Announces Additional Analysis of its AURORA 1 Phase 3 Study Data Presented at ERA-EDTA 2021 Congress
- New examination of AURORA 1 Phase 3 data demonstrates increased renal response rates with LUPKYNIS™ (voclosporin) used in combination with MMF and low-dose
About this update from Aurinia Pharmaceuticals Inc
[{"type":"text","content":"\n- New examination of AURORA 1 Phase 3 data demonstrates increased renal response rates with LUPKYNIS™ (voclosporin) used in combination with MMF and low-dose steroids in patients with lupus nephritis regardless of target urine protein creatinine ratio (UPCR) - \n\n- The assessment follows the presentation of first interim results of AURORA 2 continuation study at EULAR 2021 -\n\n VICTORIA, British Columbia & ROCKVILLE, Md.--(BUSINESS WIRE)--\n\nAurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (Aurinia or the Company) today presented an analysis of its Phase 3 AURORA 1 study data at the European Renal Association – European Dialysis and Transplant Association (ERA-EDTA) 2021 Congress. The presentation follows the recent introduction of new data from an interim analysis of the AURORA 2 continuation study at the European Alliance of Associations for Rheumatology (EULAR) 2021 Congress.\n\nIn the assessment presented at ERA-EDTA, researchers conducted a sensitivity study evaluating renal response (RR) with additional urine protein creatinine ratio (UPCR) targets given the efficacy demonstrated of voclosporin in terms of proteinuria reduction in the AURORA 1 study. This examination demonstrated that patients treated with voclosporin in addition to mycophenolate mofetil (MMF) and low-dose steroids achieved statistically significant increased renal response rates regardless of the level of UPCR, including at an even more stringent ≤0.3 mg/mg target. The data further support the efficacy and safety observed with voclosporin in the Phase 3 AURORA 1 trial.\n\n“This new look at the data on LUPKYNIS is significant because it demonstrates the ability of the therapy to deliver meaningful renal response rates at UPCR levels beyond the initial target in its Phase 3 study,” said study co-author, Maria Dall’Era, M.D., Director, UCSF Lupus Clinic and Rheumatology Clinical Research Center, Department of Medicine, University of California, San Francisco. “Multiple previous studies have suggested that level of proteinuria represents the best clinical predictor of long-term kidney outcome. Thus, seeing the benefits of LUPKYNIS even in the most stringent UPCR levels is encouraging for lupus nephritis patients and the physicians treating this challenging condition.”\n\nThe ERA-EDTA assessment of Aurinia’s Phase 3 AURORA 1 study included a total o...