Aurinia Pharmaceuticals (NASDAQ:AUPH; TSX:AUP) has completed enrollment for the Phase 3 AURORA trial ahead of schedule. The target enrollment of 324 patients was surpassed due to high patient demand with 358 lupus nephritis (LN) patients randomized in sites across 27 countries.
“We are elated by the significant interest this trial has garnered around the globe, which reinforces the need for new treatment options for patients living with lupus nephritis,” Richard Glickman, chairman and CEO, said in a statement.
The double-blind, placebo-controlled AURORA clinical trial is evaluating whether voclosporin when added to background therapy of CellCept can increase speed of and overall renal response rates in the presence of low dose steroids. The primary endpoint is complete renal response at 52 weeks, after which patients can choose to enroll in a 104-week blinded extension study.
Dr. Neil Solomons, Aurinia’s CMO, said the company expects to release results of the trial late in the fourth quarter of 2019 and complete a NDA submission in the second quarter of 2020.
