Business
Aurinia Announces Positive AURORA Phase 3 Trial Results Demonstrating Voclosporin Superiority Over Standard of Care in Lupus Nephritis
- Voclosporin achieved statistically superior Renal Response rate (p - Statistically significant results demonstrated in all pre-specified hierarchical
About this update from Aurinia Pharmaceuticals Inc
[{"type":"text","content":"\n- Voclosporin achieved statistically superior Renal Response rate (p \n\n- Statistically significant results demonstrated in all pre-specified hierarchical secondary endpoints -\n\n\n- Aurinia plans to file an NDA submission to the FDA during the first half of 2020 -\n\n\n- Company to host conference call to discuss results at 8:30 a.m. ET on Thursday, December 5, 2019 -\n\n 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 inflammatory and autoimmune conditions, today announced positive efficacy and safety results from its pivotal AURORA Phase 3 trial of voclosporin, in combination with mycophenolate (“MMF”) and low-dose corticosteroids, in the treatment of lupus nephritis (“LN”).\n\n\n“This extraordinary pivotal data confirms voclosporin’s ability to achieve statistically significant improvements in clinically meaningful endpoints for this complex disease, with a comparable safety profile to the current standard of care,” said Neil Solomons, M.D., Chief Medical Officer of Aurinia. “This data represents a significant advance for people living with LN, which can lead to irreversible kidney damage, eventual kidney failure and death.”\n\n\nThis global study in which 357 patients with active LN were enrolled, met its primary endpoint of Renal Response rates of 40.8% for voclosporin vs. 22.5% for the control (OR 2.65; p \n\n\n\n \n\n\n\nMeasure\n\n\n\nResult\n\n\n\nOdds Ratio\n[95% CI]\n\n\n\np-value\n\n\n\n\n\nPrimary Endpoint\n\n\n\nRenal Response at 52 weeks\n\n\n\nVoclosporin 40.8%\n\n\nControl 22.5%\n\n\n\n2.65 [1.64, 4.27]\n\n\n\np \n\n\n\n\n \n\n\nSecondary Endpoints\n\n\n\nRenal Response at 24 weeks\n\n\n\nVoclosporin 32.4%\n\n\nControl 19.7%\n\n\n\n2.23 [1.34, 3.72]\n\n\n\np = 0.002\n\n\n\n\n\nPartial Renal Response at 24 weeks\n\n\n\nVoclosporin 70.4%\n\n\nControl 50.0%\n\n\n\n2.43 [1.56, 3.79]\n\n\n\np \n\n\n\n\nPartial Renal Response at 52 weeks\n\n\n\nVoclosporin 69.8%\n\n\nControl 51.7%\n\n\n\n2.26 [1.45, 3.51]\n\n\n\np \n\n\n\n\nTime to UPCR ≤ 0.5\n\n\n\nVoclosporin faster\nthan Control\n\n\n\n2.02 [1.51, 2.70]\n\n\nHazard Ratio\n\n\n\np \n\n\n\n\nTime to 50% reduction in UPCR\n\n\n\nVoclosporin faster\nthan Control\n\n\n\n2.05 [1.62, 2.60]\...