Aurinia Presents Data Demonstrating LUPKYNIS(TM) (voclosporin) Efficacy Across Lupus Nephritis Biopsy Classes at National Kidney Foundation 2021 Spring Clinical Meetings
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (Aurinia or the Company) today presented additional efficacy data from the AURA-LV and AURORA 1 pivotal trials of LUPKYNIS(TM) (voclosporin) in lupus nephritis (LN). The data were shared at the National Kidney Foundation (NKF) 2021 Spring Clinical Meetings by Anca D. Askanase, M.D., M.P.H., Founder and Director of Columbia University Irving Medical Center's Lupus Center and the Director of Rheumatology Clinical Trials.
Pooled data from the AURA-LV and AURORA 1 study demonstrate that LUPKYNIS, in combination with mycophenolate mofetil (MMF) and low-dose corticosteroids, led to treatment benefits across biopsy class subgroups compared with treatment with MMF and low-dose corticosteroids alone (placebo). MMF and low-dose corticosteroids are considered standard of care (SoC) for the treatment of LN. On January 22, 2021, the U.S. Food and Drug Administration (FDA) approved LUPKYNIS in combination with a background immunosuppressive therapy regimen to treat adult patients with active LN.
"People with LN can sometimes have a delay in diagnosis and often incomplete responses to treatment, increasing their likelihood of kidney damage and other disease complications. These data support LUPKYNIS' potential as an important tool to control LN regardless of the disease classification," said Anca D. Askanase, M.D., MPH, Founder and Director of Columbia University Irving Medical Center's Lupus Center and the Director of Rheumatology Clinical Trials.
Data from 532 patients from the AURA-LV and AURORA 1 studies were integrated in a post-hoc analysis of complete renal response (CRR) by LN biopsy class. The AURA-LV and AURORA 1 studies were similar in design and patient populations. The data from both studies for subjects treated with the recommended LUPKYNIS dose of 23.7 mg twice daily (AURA-LV n=89, AURORA 1 n=179) or with matching placebo (AURA-LV n=88, AURORA 1 n= 178) were pooled for the integrated analysis. The odds ratios (OR) for CRR for LUPKYNIS versus placebo were 4.26 for pure Class III (p=0.0054), 2.59 for pure Class IV (p=0.0005), 1.5 for pure Class V (p=0.4090), and 2.68 for mixed Class III/IV and V patients (p=0.0166). Achieving an OR greater than 1 indicates that LUPKYNIS is favored over placebo. Pure Class V was the least common, with 75 patients in both studies. The clinical trials were not powered to detect a significant difference between the two treatment arms by biopsy class.
About Lupus Nephritis
LN is a serious manifestation of 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.
LUPKYNIS is the first FDA-approved oral treatment for the treatment of adult patients with active LN. A novel, structurally modified calcineurin inhibitor (CNI), LUPKYNIS has 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.
Aurinia Pharmaceuticals 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's head office is in Victoria, British Columbia, its U.S. commercial hub is in Rockville, Maryland, and the Company focuses its development efforts globally.
INDICATION AND IMPORTANT SAFETY INFORMATION
LUPKYNIS is indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active LN. Limitations of Use: Safety and efficacy of LUPKYNIS have not been established in combination with cyclophosphamide. Use of LUPKYNIS is not recommended in this situation.
IMPORTANT SAFETY INFORMATION
BOXED WARNINGS: MALIGNANCIES AND SERIOUS INFECTIONS