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Aurinia Completes Voclosporin Drug-Drug Interaction Study Demonstrating No Clinically Significant Interaction With Mycophenolate Mofetil
- Data support differentiation of voclosporin as a potential best-in-class CNI - VICTORIA, British Columbia--(BUSINESS WIRE)-- Aurinia Pharmaceuticals Inc.
About this update from Aurinia Pharmaceuticals Inc
[{"type":"text","content":"\n- Data support differentiation of voclosporin as a potential best-in-class CNI -\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 the completion of a FDA-requested clinical drug-drug interaction (“DDI”) study in patients with lupus that investigated the potential effect of voclosporin on blood levels of mycophenolate acid (“MPA”), the active metabolite of mycophenolate mofetil (“MMF”). MMF, also known as CellCept®, is considered by treating physicians to be part of the current standard of care for lupus nephritis (“LN”) in the United States.\n\n\n“These results support our belief that voclosporin has no clinically significant impact on MPA levels. These data give us further confidence that the addition of voclosporin to MMF and corticosteroids for the treatment of LN can lead to predictable immunomodulation therapy and optimal results for people suffering from this devastating autoimmune disorder,” commented Neil Solomons, M.D., Chief Medical Officer at Aurinia.\n\n\nThis FDA-requested clinical DDI study aimed to measure, and potentially quantify, the impact voclosporin may have on MPA blood levels when given concomitantly with MMF in patients with lupus. The study results indicate that the coadministration of voclosporin with MMF had no clinically significant impact on MPA blood concentrations. In past studies, it was reported that the legacy calcineurin inhibitors (“CNIs”) inhibit the multidrug-resistance-associated protein 2 (MRP-2) transporter in the biliary tract thereby preventing the excretion of mycophenolic acid glucuronide (MPAG) into the bile leading to the enterohepatic recirculation of MPA1. This adverse impact of cyclosporine on MPA pharmacokinetics has resulted in a 30 – 50% reduction in MPA exposure when used in combination1.\n\n\n“These DDI study results further enhance our understanding of voclosporin’s differentiated profile, and we look forward to submitting these data, along with the results from the AURORA Phase 3 trial next year as part of our NDA submission,” stated Peter Greenleaf, Chief Executive Officer of Aurinia.\n\n\nAurinia remains on track to report results from...