Aurinia Presents Breadth of Data at ASN 2023 Demonstrating Clinical Importance of LUPKYNISⓇ for Managing Lupus Nephritis

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company), announced today the presentation of nine studies (one oral and eight posters) at the annual American Society of Nephrology Kidney Week 2023 Convergence taking place in Philadelphia, PA, November 2-5. The data reinforce previous findings on the safety and effectiveness of LUPKYNIS^Ⓡ (voclosporin), a second generation calcineurin inhibitor (CNI), for the treatment of adult patients with active LN, as shown in the AURORA Clinical Program, comprised of the Phase 3 AURORA 1 clinical trial and the Phase 3 AURORA 2 extension study.

Results from an analysis of kidney biopsy samples collected from patients participating in the AURORA Clinical Program were presented in an oral session. To characterize the long-term renal impact of LUPKYNIS^Ⓡ at the histologic level, researchers analyzed repeat kidney biopsies from a subset of patients who completed one year of treatment in the AURORA 1 clinical trial, including 16 patients in the active treatment arm who received LUPKYNIS^Ⓡ in combination with mycophenolate mofetil (MMF) and low-dose glucocorticoids and 10 patients in the control arm treated with MMF and low-dose glucocorticoids alone.

Histologic changes from baseline to approximately 18 months post-treatment were assessed using the modified National Institutes of Health (NIH) activity and chronicity indices, wherein the activity index provides a measure of active inflammation in LN, and the chronicity index provides a measure of irreversible kidney injury. Activity scores for both arms improved to a similar degree, while the chronicity scores remained stable in both arms. These results confirmed the safety profile of LUPKYNIS^Ⓡ showing no associated chronic injury with use. Importantly, LUPKYNIS^Ⓡ -treated patients in the overall AURORA 2 cohort maintained stable renal function over the last two years of the study, as measured by eGFR analysis and experienced numerically greater mean reductions in urine protein creatinine ratio (UPCR), compared to patients in the control arm.

“These findings from a small subset of patients further strengthen the overall evidence supporting the long-term safety of LUPKYNIS^Ⓡ in LN patients. The addition of LUPKYNIS^Ⓡ to MMF and low-dose glucocorticoids to treat LN can lead to significantly earlier and greater reductions in proteinuria while allowing patients to maintain stable renal function. This is a critical aspect to consider for patients with LN, as proteinuria is associated with a major decline in kidney function and, in some cases, kidney failure. This increased understanding of the long-term safety and efficacy profile of LUPKYNIS^Ⓡ will contribute to improving outcomes over time for this patient population,” said Samir V. Parikh, M.D., nephrologist at the Ohio State University Wexner Medical Center and lead study author.