Aurina to Present Supportive Aurora 2 Continuation Study Interim Analysis Demonstrating Long-term Safety & Efficacy of Lupkynis™ (Volclosporin) in Subjects with Lupus Nephritis
VICTORIA, British Columbia & ROCKVILLE, Md.–(BUSINESS WIRE)–Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (Aurinia or the Company) announced today that a supportive interim analysis of its AURORA 2 continuation study will be presented at the upcoming European Alliance of Associations for Rheumatology (EULAR) 2021 Congress June 2-5, 2021.
Subjects who completed one year of treatment in Aurinia’s Phase 3 AURORA study (AURORA 1) were eligible to enroll in the two-year, blinded, controlled continuation study (AURORA 2). The interim analysis to be presented at EULAR evaluated subjects with up to two years of total treatment: one year from AURORA 1 and up to one year in AURORA 2. Previously reported results from AURORA 1 and the Phase 2 AURA-LV study showed that compared with mycophenolate mofetil (MMF) and low-dose steroids alone, the addition of voclosporin significantly increased the renal response rate and reduced proteinuria, as measured by urine protein creatinine ratio (UPCR), in subjects with lupus nephritis (LN) at approximately one year of treatment (48 weeks in AURA-LV and 52 weeks in AURORA 1). The interim analysis of AURORA 2 showed that subjects in the LUPKYNIS treatment arm sustained meaningful reductions in proteinuria, with no change in mean estimated glomerular filtration rate (eGFR) at 104 weeks of treatment.
“Following the enhanced renal response rates achieved in AURORA 1, these additional data show that LUPKYNIS also provides the ability to sustain positive outcomes over time,” said Amit Saxena, M.D., Assistant Professor at the Department of Medicine at NYU Langone Medical Center. “The strong and growing pool of data available on LUPKYNIS clearly demonstrates the clinical value and safety of this therapy for a patient population that has historically been challenged with a lack of effective treatment options.”
An interim analysis of the 216 blinded AURORA 2 study subjects (116 voclosporin; 100 control arm) was performed as part of the US New Drug Application. Data from 124 subjects (73 voclosporin; 51 control arm) who had received 104 weeks of continuous treatment was analyzed. Proteinuria continued to improve with a greater reduction in UPCR from pre-treatment baseline to year two observed in the voclosporin arm compared to the control arm (-3.1 vs -2.1 mg/mg; p=0.0004). A greater reduction in proteinuria between arms was also observed between 1 and 2 years (1.0 vs 0.6 mg/mg; voclosporin vs control). Renal function as determined by eGFR remained stable over 104 weeks in both groups compared to baseline assessments. Mean eGFR: 79.6 vs 79.0 mL/min for the voclosporin arm and 78.9 vs 82.9 mL/min for the control arm.
Additionally, there were no unexpected new AEs observed in patients who continued with voclosporin treatment compared to control-treated patients for more than one year.
“Seeing these first results from our continuation study is extremely encouraging as we continue to work to bring LUPKYNIS to patients following its FDA approval earlier this year,” said Neil Solomons, M.D., Chief Medical Officer at Aurinia. “We look forward to providing updates on our continuation study results and continuing to support patients and physicians in making informed decisions about the treatment of LN.”
About Lupus Nephritis
Lupus nephritis 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.
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.
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