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Aurinia Announces AURORA Phase 3 Clinical Data for Voclosporin in Lupus Nephritis to be Presented at National Kidney Foundation 2020 Spring Clinical Meetings
- Data to be shared as a late-breaking oral presentation during the live virtual NKF conference - VICTORIA, British Columbia--(BUSINESS WIRE)-- Aurinia
About this update from Aurinia Pharmaceuticals Inc
[{"type":"text","content":"\n- Data to be shared as a late-breaking oral presentation during the live virtual NKF conference -\n\n VICTORIA, British Columbia--(BUSINESS WIRE)--\n\nAurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin in multiple indications, today announced that clinical data from its AURORA Phase 3 trial will be highlighted in a late-breaking oral presentation during the National Kidney Foundation (“NKF”) 2020 Spring Clinical Meetings, which will be held as a live-virtual meeting per recommendations by the Centers for Disease Control and Prevention (“CDC”). The AURORA pivotal trial evaluated voclosporin in combination with mycophenolate (“MMF”) and low-dose corticosteroids for the treatment of lupus nephritis (“LN”).\n\n\nAurinia previously announced positive efficacy and safety results from the AURORA Phase 3 pivotal trial in December 2019. These data will be submitted as part of the rolling submission for the voclosporin new drug application (“NDA”), which the Company expects to complete by the end of the second quarter of 2020.\n\n\nFull Presentation Details\n\n\nTitle: Aurora Phase 3 Trial Demonstrates Voclosporin Statistical Superiority Over Standard of Care in Lupus Nephritis (LN)\nSession: Late-Breaking Abstract Presentations\nPresenter: Keisha Gibson, M.D., Ph.D., University of North Carolina School of Medicine, Chapel Hill, NC\nDate: Thursday, March 26, 2020; 4:15 p.m. – 4:45 p.m. CT\n\n\nFollowing the session, a reprint of the slide presentation will be accessible from Aurinia’s website at: https://ir.auriniapharma.com/presentations.\n\n\nAbout AURORA\n\n\nThe AURORA Phase 3 clinical trial is a global, double-blind, placebo-controlled study to evaluate whether voclosporin when added to background therapy of mycophenolate mofetil (MMF)/CellCept® can increase speed of and overall renal response rates in the presence of low dose steroids. The primary endpoint for the study is complete renal response at 52 weeks, after which patients can choose to enroll into a 104-week blinded extension study. Renal response was defined as UCPR of ≤ 0.5 mg/mg, eGFR ≥ 60 mL/min/1.73 m2, or no confirmed decrease from baseline in eGFR of > 20%, presence of sustained, low dose steroids and no administration of rescue medication. The target enr...