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Aurinia Presents Additional AURORA Pivotal Trial Safety Data at the ERA-EDTA Virtual Congress 2020
VICTORIA, British Columbia--(BUSINESS WIRE)-- Aurinia Pharmaceuticals Inc. (Nasdaq:AUPH / TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical
About this update from Aurinia Pharmaceuticals Inc
[{"type":"text","content":" VICTORIA, British Columbia--(BUSINESS WIRE)--\nAurinia Pharmaceuticals Inc. (Nasdaq:AUPH / TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple indications, announced that additional safety data from the completed AURORA pivotal trial of voclosporin were shared at the European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) 2020 Virtual Congress in an oral presentation given by nephrologist Dawn Caster, M.D., Assistant Professor of Medicine at the University of Louisville School of Medicine.\n\n\nThe data showed that pre-specified confirmed estimated glomerular filtration rate (eGFR) decreases of over 30% were similar in both AURORA trial patient groups, with 10.1% reported in the voclosporin group and 10.2% in the control arm (p=0.971). eGFR is a standard measure of kidney function. No clinically meaningful differences between the treatment (23.7 mg twice daily oral voclosporin) and control groups were seen at any timepoints in the study on this parameter or in serum creatinine levels, another biomarker for renal damage. All patients in the AURORA study were treated with mycophenolate (MMF) and a background of corticosteroids. MMF is considered the standard-of-care for lupus nephritis, although unapproved by the FDA for that use.\n\n\n“This important new aspect of the full AURORA results further adds to the existing dataset that shows voclosporin’s benefit over the standard-of-care with no apparent safety penalty,” said Neil Solomons, M.D., Chief Medical Officer of Aurinia. “Our deep analysis of the comprehensive voclosporin clinical program continues to illustrate its potential as a treatment for lupus nephritis. This data has been submitted to the FDA as part of voclosporin’s recently completed New Drug Application.”\n\n\nAs previously reported, AURORA met its primary endpoint, achieving statistically superior Renal Response rates of 40.8% for voclosporin versus 22.5% for the control (OR 2.65, 95% CI; p \n\n\n\nVoclosporin was well tolerated with no unexpected safety signals. Serious adverse events (SAEs) were reported in 20.8% of voclosporin patients versus 21.3% in the control arm. Infection was the most commonly reported SAE with 10.1% of voclosporin patients versus 11.2% of patients in the control arm. Overall mor...