Aurinia Presents Results from the Two-Year AURORA 2 Continuation Study at the 2022 European Renal Association (ERA) Congress

Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (Aurinia or the Company), a biopharmaceutical company committed to delivering therapeutics that change the course of autoimmune disease, today presented for the first time the results of the AURORA 2 continuation study evaluating the long-term safety and tolerability of LUPKYNIS (voclosporin) for the treatment of adults with active lupus nephritis (LN), a serious complication in patients with systemic lupus erythematosus (SLE). The results were presented during an oral session at the 59th European Renal Association (ERA) Congress, held in Paris and virtually May 19-22, 2022.

The AURORA 2 study assessed long-term safety and tolerability of voclosporin compared to placebo (both taken in combination with mycophenolate mofetil (MMF) and low-dose oral steroids) in patients with LN receiving treatment for an additional 24 months following completion of one year on treatment in the AURORA 1 study. The primary endpoint was safety and included assessments of adverse events, deaths, and hematological assessments. Secondary endpoints include renal response, renal flare, renal outcomes, and changes in urine protein to creatinine ratio (UPCR) and estimated glomerular filtration rate (eGFR).

“Lupus nephritis is a severe complication of lupus that will occur in up to half of patients diagnosed with SLE,” said Y.K. Onno Teng, M.D., Ph.D., Leiden University Medical Center, Leiden, The Netherlands, presenting author of the AURORA 2 ERA presentation and principal study investigator. “These results demonstrated that patients on long-term voclosporin therapy continue to experience clinically relevant benefits, including significant preservation of kidney function long-term, with no unexpected, new safety signals.”

Voclosporin was well tolerated during the study period with a similar safety profile to control and no unexpected safety signals. Specific findings included:

• Overall rates of serious adverse events were similar in both the control (28.0%) and voclosporin (26.0%) arms and there was no increase in infectious events.
• Generally adverse events were low and decreased over time on treatment.
  • Significant and meaningful reductions in proteinuria achieved in AURORA 1 were maintained.
• In AURORA 2, there was a significant difference in eGFR slope in favor of voclosporin (-0.2 mL/min/1.73 m2) compared to control arm (-5.4 mL/min/1.73 m2).
• There was a small, expected, and early decrease in mean eGFR in the first four weeks of treatment in AURORA 1, after which eGFR remained stable through the end of AURORA 2.
• The mean UPCR was lower in the voclosporin-treated groups at all time points during the three years.
• There were four deaths in the active control group during AURORA 2, while none in the voclosporin-treated group.

“When treating patients with lupus nephritis, the ultimate goal is to preserve kidney function,'' said Neil Solomons, M.D., Chief Medical Officer at Aurinia. “We’re thrilled to build out the body of data that reinforces voclosporin as a safe and effective treatment option for lupus nephritis patients over the long term.”