Benzinga | Jun 7, 2021 07:05AM EDT

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(tm) (voclosporin) used in combination with MMF and low-dose steroids in patients with lupus nephritis regardless of target urine protein creatinine ratio (UPCR) -

- The assessment follows the presentation of first interim results of AURORA 2 continuation study at EULAR 2021 -

Aurinia 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.

In 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.

"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."

The ERA-EDTA assessment of Aurinia's Phase 3 AURORA 1 study included a total of 179 participants in the voclosporin (23.7 mg BID) arm and 178 participants in the control arm from the AURORA 1 trial. All participants received MMF (target 1 g BID) and low-dose oral steroids (initiated at 20-25 mg/day and tapered to 2.5 mg/day at 16 weeks). The UPCR component of RR was revised to include UPCR targets at 0.2 mg/mg intervals above and below the original ?0.5 target used for the primary endpoint in AURORA 1 (i.e., ?0.7 mg/mg or ?0.3 mg/mg, respectively). Complete renal response (CRR) defined as achievement of UPCR ?0.5 mg/mg with stable renal function (eGFR ?60 mL/min/1.73 m2 and no decrease >20% from baseline) in the presence of sustained, low-dose steroids (in the 8 weeks prior to assessment) and no use of rescue medication. Complete renal response analysis at approximately one year included Week 52 data from AURORA 1. Odds ratios for RR at 26 weeks and 52 weeks of treatment were analyzed using a logistic regression model with terms for treatment, baseline UPCR, biopsy class, and MMF use at baseline and region.