Aurinia Pharmaceuticals Inc. announced 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. A propensity analysis of the Aspreva Lupus Management Study (ALMS) and AURORA 1 study suggested that LUPKYNIS?

plus standard of care may reduce patient exposure to toxicities associated with taking mycophenolate mofetil (MMF) and glucocorticoids alone and demonstrated earlier reductions in proteinuria. Safety and efficacy outcomes for propensity-matched patients with active LN from the ALMS and AURORA 1 study were assessed at three and six months. The data showed an improved safety profile over the first six months of treatment with LUPKYNIS?

in combination with low-dose glucocorticoids and lower-dose MMF without compromising efficacy. Patients who received the LUPKYNIS? -based regimen experienced reductions in exposure to glucocorticoids and MMF and earlier reductions in proteinuria compared to patients treated with higher doses of glucocorticoids and MMF.

In a subset analysis of three years of data from the AURORA Clinical Program, 44.4% of Black patients treated with LUPKYNIS? experienced an improvement in complete renal response at 36 months (n=18) compared to 14.3% of Black patients who achieved complete renal response when treated with MMF and glucocorticoids alone (n= 7). These findings among Black patients, a population that often experiences worse outcomes and lower responses to LN treatment, are consistent with the treatment response seen across all racial and ethnic groups treated with LUPKYNIS?

in the AURORA Clinical Program.