Aurinia Presents Breadth of Data from AURORA Clinical Program Underscoring Value of LUPKYNISⓇ (voclosporin) for Patients with Lupus Nephritis at ACR 2023

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company), announced today the presentation of five studies (one oral and four posters) at the annual American College of Rheumatology Convergence 2023 taking place in San Diego, CA, November 10-15. 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 lupus nephritis (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.

An oral presentation demonstrated that initial therapy with LUPKYNIS plus standard of care reduced proteinuria and patient exposure to toxicities, compared to a conventional regimen consisting of higher doses of both mycophenolate mofetil (MMF) and glucocorticoids alone. Safety and efficacy outcomes for propensity-matched patients with active LN from the Aspreva Lupus Management Study (ALMS) and the AURORA 1 study were assessed at three and six months. In ALMS, MMF was dosed to a target of 3 g/day with oral glucocorticoids initiated at a maximum dose of 60 mg/day and tapered every two weeks to 10 mg/day. In AURORA 1, patients received LUPKYNIS 23.7 mg BID in combination with MMF (target dose 2 g/day) and oral glucocorticoids (starting dose of 25 mg/day tapered to 2.5 mg/day by Week 16). 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.

“The findings from the propensity analysis of the ALMS and AURORA 1 studies support the use of a triple immunosuppressive regimen containing LUPKYNIS for the treatment of active LN. Conventional therapeutic regimens for LN have incomplete efficacy and significant toxicities. This study adds to the growing body of data supporting the evolving treatment paradigm for LN,” said lead study author Maria Dall’Era, M.D., Chief and Professor of Medicine in the Division of Rheumatology, University of California, San Francisco.

A post-hoc, pooled analysis of the Phase 2 AURA-LV and Phase 3 AURORA 1 studies found that LUPKYNIS with MMF and low-dose glucocorticoids resulted in earlier and greater reductions in proteinuria in LN patients with proteinuria >=2 g/day and greater numeric achievement of complete renal response across biopsy classes, races, and ethnicities. 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 complete renal response rates at one year than patients treated with MMF and low-dose steroids alone, regardless of baseline demographics or clinical characteristics.