Aurinia Pharmaceuticals has completed patient enrollment for its Phase 3 trial that will assess the potential of voclosporin as an add-on to standard treatment regimens in patients with lupus nephritis, the company announced.
The enrollment phase was finished ahead of schedule and exceeded expectations, recruiting more participants than initially planned due to high patient demand. A total of 358 patients with active lupus nephritis were recruited across clinical sites in 27 countries.
“We would like to thank our trial patients, physicians, trial site staff, and advocacy groups for their extraordinary efforts which has led to this result,” Neil Solomons, MD, chief medical officer of Aurinia, said in a press release.
Voclosporin is an investigational calcineurin inhibitor that works through a dual approach: It both blocks T-cell immune responses and stabilizes podocytes — specialized cells in the kidney that participate in blood filtration processes. As a result, researchers believe it could improve the outcomes of lupus nephritis patients when added to standard therapies.
In fact, a prior Phase 2b trial, called AURA-LV (NCT02141672), showed that adding voclosporin to standard of care eliminated kidney inflammation in twice as many patients as standard treatment alone. The medicine was also found to be more effective at treating lupus nephritis than other calcineurin inhibitors.
The AURORA Phase 3 trial (NCT03021499) will now confirm the findings in a larger patient population, and Aurinia hopes that results will support a new drug application submission to the U.S. Food and Drug Administration by 2020.
In the randomized trial, participants will receive either voclosporin or a placebo for one year. All patients will also receive CellCept (mycophenolate mofetil) and low-dose steroid treatment.
Researchers will primarily evaluate if voclosporin increases complete kidney responses after one year of treatment, with secondary goals focused on the speed and duration of responses. After completing the 52-week study, participants may choose to enroll in a two-year blinded extension study.
The company expects to announce topline data from AURORA by the end of 2019.
“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,” said Richard M. Glickman, chairman and CEO of Aurinia. “I continue to be impressed by the level of dedication exhibited by our team to execute this trial with great diligence and expediency.”