November 8, 2019
Aurinia Pharmaceuticals announced results from a study showing that their investigational drug voclosporin did not significantly impact the levels of mychophenolate acid (MPA), the main ingredient in the common standard treatment mycophenolate mofetil (CellCept®) for lupus nephritis.
The drug-drug interaction (DDI) study was requested by the Food and Drug Administration to measure the impact of voclosporin on MPA when given with mycophenolate mofetil.
“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.
The company expects to report results by end of 2019 from a Phase 3 trial called AURORA that is testing voclosporin in people with lupus nephritis. AURORA is a global, randomized, 52-week double-blind, placebo-controlled Phase 3 study comparing the efficacy of voclosporin versus placebo when added to standard of care consisting of mycophenolate mofetil and corticosteroids in patients with active lupus nephritis.
The Lupus Research Alliance looks forward to seeing these Phase 3 results.