Benzinga | Dec 9, 2021 09:45PM EST

Aurinia Announces Topline Results From the AURORA 2 Continuation Study of LUPKYNIS (voclosporin) for the Treatment of Adults With Active Lupus Nephritis (LN) Show Sustained Meaningful Reductions in Proteinuria Compared to Mycophenolate Mofetil (Mmf) and Low-dose Oral Corticosteroids Alone, the Active Study Control

Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (Aurinia or the Company), a biopharmaceutical company committed to delivering therapeutics that change the course of autoimmune disease, today announced positive topline results from the AURORA 2 continuation study evaluating the long-term safety and tolerability of LUPKYNIS(tm) (voclosporin) for the treatment of adults with active lupus nephritis (LN), a serious complication in patients with systemic lupus erythematosus (SLE). In combination with background immunosuppressive therapy, LUPKYNIS is the first and only FDA-approved medicine with three years of pivotal trial results, including long-term safety data, within LN.

"Up to half of patients with systemic lupus erythematosus will develop lupus nephritis, that can result in severe and permanent damage to the kidneys and, in some cases, renal failure," said Amit Saxena, M.D., assistant professor, department of medicine at NYU Langone Medical Center and an investigator in the AURORA 2 study. "These highly anticipated long-term results, of voclosporin in adult patients with LN, show consistent safety with the phase 3 AURORA 1 study and a benign impact on eGFR even after up to three years of treatment while maintaining the impressive reductions in proteinuria seen in AURORA 1."

"We are pleased by the final results of the AURORA 2 continuation study evaluating LUPKYNIS for the treatment of lupus nephritis, which supports the long-term safety and tolerability for up to three years," said Neil Solomons, M.D., Chief Medical Officer of Aurinia. "Furthermore, we observed that efficacy was maintained in combination with MMF and low-dose steroids."

Highlights of topline results from AURORA 2:

In the 116 subjects in the voclosporin-treated group who enrolled in AURORA 2, mean estimated glomerular filtration rate (eGFR) was stable over 36 months.Compared to the active control group, the voclosporin-treated group showed an increase from baseline eGFR at the end of the studies of +2.7 mL/min.The drug was well tolerated with no unexpected safety signals observed. There were comparable serious adverse events (SAEs) rates in both arms (19% voclosporin vs. 24% control).The active control group had a higher percentage of withdrawals compared to the voclosporin-treated group, 15.0% vs. 12.9% respectively.There were four deaths during AURORA 2 in the active control group, none in the voclosporin-treated group.The mean Urine Protein Creatinine Ratio (UPCR) was lower in the voclosporin-treated groups at all time points during the three years."Aurinia's LN clinical program, including AURA-LV and both the AURORA trials, represents the largest successful LN program to date. The latest results, featuring consistent outcomes over three years, serve to reinforce LUPKYNIS as a safe and effective, important treatment option for patients living with lupus nephritis," said Peter Greenleaf, President and CEO of Aurinia. "On behalf of Aurinia, I extend our deepest gratitude to the participants, their families, and the health care providers involved in these studies."

Aurinia also announced the initiation of ENLIGHT-LN, a U.S.-based prospective, observational registry of adult patients with LN treated with LUPKYNIS. The registry is intended to support the interests of patients, clinicians, regulatory bodies, payers and industry by obtaining longitudinal data on LUPKYNIS. The Company aims to initiate approximately 75 sites across the U.S. Additional details regarding this registry will be provided in 2022.

Aurinia will host a conference call on Thursday, December 9 at 8:30 am EST to review these AURORA 2 topline results. The audio webcast can be accessed under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com or by dialing +1-877-407-9170 (Toll-free U.S. & Canada).