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Aurinia Announced Publication of AURORA 1 Phase 3 Study Results with LUPKYNIS in The Lancet; Study Showed Statistically Superior Complete Renal Response Rates at 52 Weeks Compared to Treatment With Mmf and Low-dose Corticosteroids Alone

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) today announced that The Lancet, aninternational, peer-reviewed medical journal, published the results of the Company's Phase 3 AURORA 1 study evaluating LUPKYNIS (voclosporin) in adults with lupus nephritis (LN)...

05/10/2021 06:11
Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) today announced that The Lancet, aninternational, peer-reviewed medical journal, published the results of the Company's Phase 3 AURORA 1 study evaluating LUPKYNIS (voclosporin) in adults with lupus nephritis (LN). The AURORA 1 study results demonstrate that LUPKYNIS in combination with mycophenolate mofetil (MMF) and low-dose corticosteroids led to statistically superior complete renal response rates at 52 weeks compared to treatment with MMF and low-dose corticosteroids alone, with a comparable safety profile. In fact, separation in efficacy between treatment groups was observed as early as 4 weeks. MMF and corticosteroids are typical SoC immunosuppressive agents used 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. "Lupus nephritis can be a devastating condition if not diagnosed and managed early," stated Brad H. Rovin, M.D., Professor of Medicine and the Director of the Division of Nephrology, Ohio State University Wexler Medical Center, an AURORA clinical trial investigator and the lead author of the publication. "The publication of AURORA 1 data validates the importance of voclosporin (LUPKYNIS) in early disease intervention for LN. These data establish voclosporin as an efficacious and safe, rapid-acting new treatment option for patients in need." The published AURORA 1 results are based on the global Phase 3 randomized, double-blind, placebo-controlled study (NCT03021499) designed to evaluate the efficacy and safety of LUPKYNIS (23.7 mg twice daily) when added to background therapy of MMF and low-dose corticosteroids, compared to background therapy alone in an ethnically and racially diverse patient population with active LN. The AURORA 1 study enrolled 357 patients with a diagnosis of systemic lupus erythematosus (SLE) and LN according to the American College of Rheumatology criteria and a kidney biopsy within two years that showed Class III, IV and/or V LN. The primary endpoint was complete renal response at 52 weeks defined as urine protein creatinine ratio (UPCR) ≤0.5 mg/mg, with stable renal function (defined as estimated glomerular filtration rate [eGFR] ≥60 mL/min/1.73 m2 or no confirmed decrease from baseline in eGFR of >20%), no administration of rescue medication, and no more than 10 mg prednisone equivalent per day for three or more consecutive days or for seven or more days during Weeks 44 through 52. Key secondary hierarchical endpoints were complete renal response (CR) at Week 24 (based on primary endpoint definition with steroid dosing assessed during Weeks 16 through 24), partial renal response (PR), defined as a 50% reduction in UPCR from baseline, at Weeks 24 and 52, time to UPCR of ≤0.5 mg/mg and time to 50% reduction in UPCR from baseline. AURORA 1 met its primary endpoint, achieving statistically superior complete renal response rates of 41% in the LUPKYNIS group versus 23% in the control group (odds ratio [OR] 2.65, 95% confidence interval [CI] 1.64-4.27; p < 0.0001). LUPKYNIS also achieved statistical significance in all pre-specified hierarchical secondary endpoints, including improved time to 50% reduction from baseline in UPCR or and time to UPCR <0.5 mg/mg compared to control. The robustness of the data was also supported by all pre-specified subgroup analyses (age, sex, race, biopsy class, region and MMF use at screening) favoring LUPKYNIS. LUPKYNIS was well tolerated with no unexpected safety signals. Serious adverse events (SAEs) were reported in 21% of those treated with LUPKNYIS and in 21% of those in the control group. Infection and infestations were the most commonly reported SAEs, in 10% of the LUPKYNIS group and 11% of the control group. Overall mortality in the AURORA 1 trial was low, with six deaths observed; one in the LUPKYNIS group and five in the control group. Additionally, the LUPKYNIS group showed no notable decrease at Week 52 in mean eGFR or increase in mean blood pressure, lipids or glucose, which are common adverse events associated with traditional calcineurin inhibitors (CNIs). "The FDA approval of LUPKYNIS and the publication of the AURORA 1 results support and underscore our efforts to improve the health outcomes of people living with the devastating impacts of LN," said Robert Huizinga, Ph.D. R.N., Executive Vice President of Research, Aurinia. "It is the culmination of many years of research both within Aurinia and with investigators and patients and we look forward to continuing our research with this important compound, and to sharing longer-term safety and efficacy data from the ongoing AURORA 2 continuation study in the coming months."