Aurinia Announces Updated Interim Results from the AURORA 2 Continuation Study of LUPKYNIS (voclosporin) for the Treatment of Lupus Nephritis

• Longest available outcomes data with LUPKYNIS will be presented virtually during American College of Rheumatology (ACR) Convergence 2021; final results expected by the end of 2021 –
• Updated interim analysis shows sustained safety and tolerability of LUPKYNIS compared with placebo -
• Individuals treated with LUPKYNIS sustained meaningful reductions in proteinuria with stable eGFR at 30 months -

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company), a biopharma company committed to delivering therapeutics that change the course of autoimmune disease, today announced updated interim results from the AURORA 2 continuation study evaluating the long-term safety and tolerability of LUPKYNIS™ (voclosporin) for the treatment of lupus nephritis (LN) in patients with systemic lupus erythematosus (SLE), a chronic and complex autoimmune disease. The updated results will be presented virtually on Nov. 8 during Plenary Session III at 10:45 a.m. EST during The American College of Rheumatology (ACR) Convergence 2021.

In the interim analysis, patients in the voclosporin group maintained meaningful reductions in proteinuria. From pre-treatment baseline in AURORA 1 to month 30 in AURORA 2, mean urine protein/creatinine ratio (UPCR) was -3.32 mg/mg for the voclosporin group (n=90) and -2.55 mg/mg for the control group (n=78). In the voclosporin group, estimated glomerular filtration rate (eGFR), an important measurement of kidney function, remained stable through month 30. There were no unexpected new adverse events reported in the voclosporin group compared to the control group.

“In this updated interim analysis, reductions in proteinuria were sustained with no impact on renal function at a total of 30 months of treatment with voclosporin,” said Amit Saxena, M.D., assistant professor, department of medicine at NYU Langone Medical Center and presenting author of the AURORA 2 study. “The consistent outcomes over time reinforce confidence in LUPKYNIS as an important treatment choice for people experiencing the dangerous manifestation of lupus nephritis.”

AURORA 2 (NCT03597464) is a Phase 3 randomized, double-blind, placebo-controlled clinical trial to assess the long-term safety and tolerability of voclosporin, in addition to the standard of care, for the treatment of LN in patients with SLE. Patients who completed 12 months of treatment in the Phase 3 AURORA 1 study were eligible to enroll in the AURORA 2 continuation study with the same randomized treatment of voclosporin at 23.7 mg twice daily or placebo, in combination with mycophenolate mofetil (MMF) at 1 g twice daily with either no or low-dose oral steroids, for an additional 24 months. A total of 216 LN patients continued into AURORA 2, with 116 patients in the voclosporin group and 100 patients in the control group. 90 and 78 patients, respectively, received 30 months of total treatment as of this interim analysis. Final results from the AURORA 2 study are expected by the end of 2021. Results from the completed Phase 3 randomized, double-blind, placebo-controlled, multicenter AURORA 1 study (NCT03021499) were recently published in The Lancet.

“We are encouraged to see the continued positive outcomes with LUPKYNIS and look forward to seeing and presenting the complete results from AURORA 2 in the coming months,” said Neil Solomons, M.D., Chief Medical Officer at Aurinia.

About Lupus Nephritis
Lupus nephritis (LN) is a serious manifestation of systemic lupus erythematosus (SLE), a chronic and complex autoimmune disease. About 200,000-300,000 people live with SLE in the U.S. and approximately one out of three of these individuals develop LN. If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney, resulting in kidney failure. Black and Asian individuals with SLE are four times more likely to develop LN and individuals of Hispanic ancestry are approximately twice as likely to develop the disease when compared with Caucasian individuals. Black and Hispanic individuals with SLE also tend to develop LN earlier and have poorer outcomes when compared to Caucasian individuals.

About LUPKYNIS
LUPKYNIS™ is the first FDA-approved oral medicine for the treatment of adult patients with active lupus nephritis (LN). LUPKYNIS is a novel, structurally modified calcineurin inhibitor (CNI) with a dual mechanism of action, acting as an immunosuppressant through inhibition of T-cell activation and cytokine production and promoting podocyte stability in the kidney. The recommended starting dose of LUPKYNIS is three capsules twice daily with no requirement for serum drug monitoring. Dose modifications can be made based on Aurinia’s proprietary personalized eGFR-based dosing protocol. Boxed Warning, warnings and precautions for LUPKYNIS are consistent with those of other CNI-immunosuppressive treatments.

About Aurinia
Aurinia is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company recently introduced the first FDA-approved oral therapy indicated for the treatment of adult patients with active lupus nephritis (LN). Aurinia’s head office is in Victoria, British Columbia; its U.S. commercial hub is in Rockville, Maryland; and the Company focuses development efforts globally.