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Aurinia Pharmaceuticals Announces Kidney Biopsies Sub-study Data from the LUPKYNIS® (voclosporin) AURORA 2 Clinical Trial Presented at Congress of Clinical Rheumatology East Conference
First study to assess histologic changes in the kidneys of patients with lupus nephritis treated with LUPKYNIS® (voclosporin) Treatment was not associated
About this update from Aurinia Pharmaceuticals Inc
[{"type":"text","content":"\nFirst study to assess histologic changes in the kidneys of patients with lupus nephritis treated with LUPKYNIS® (voclosporin)\n\n\nTreatment was not associated with chronic injury, with the average chronicity index remaining stable in both treatment arms from baseline to follow-up\n\n\nActivity scores decreased in conjunction with improvements in urine protein creatinine ratio (UPCR) in both treatment arms\n\n\nData further reinforces differentiation of LUPKYNIS from first generation calcineurin inhibitors (CNIs)\n\n\n EDMONTON, Alberta--(BUSINESS WIRE)--\nAurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) today announced data from the kidney biopsy sub-study of the AURORA clinical trial program (AURORA 1 and AURORA 2 Extension Study) was presented at the Congress of Clinical Rheumatology East Conference May 4 – 7, 2023.\n\n\nThe addition of LUPKYNIS to standard of care MMF and low-dose steroids in Aurinia’s Phase 3 AURORA program led to significantly earlier and greater reductions in proteinuria while maintaining stable renal function, as evidenced by a stable estimated glomerular filtration rate (eGFR) slope over time.\n\n\nTo further characterize the long-term impact of LUPKYNIS on the kidney at the histologic level, repeat biopsies were collected from patients participating in the sub-study. Specifically, repeat renal biopsies were obtained from 16 patients in the LUPKYNIS arm and 10 patients in the active control arm over 18 months from study entry. Baseline and follow-up activity scores, a measure of active inflammation in LN, and chronicity scores, a measure of irreversible kidney injury, were obtained using a validated assessment tool.\n\n\n“We are encouraged by these results,” said Dr. Greg Keenan, Chief Medical Officer of Aurinia. “Seeing similar improvement in the activity scores and absence of change in the chronicity scores with the LUPKYNIS treated patients as compared to those on MMF and low dose steroids alone, without histologic findings of chronic CNI nephrotoxicity, strengthens the totality of the evidence supporting the long-term efficacy and safety of LUPKYNIS and further differentiates the safety of this second-generation treatment from the legacy, first generation CNIs.”\n\n\nHigher rates of both complete renal response (CRR) and partial renal response (PRR) were observed in LUPKYNIS tr...