Aurinia Starts Phase 3 Trial of Voclosporin, Which Is Proving Effective Against Lupus Nephritis
Aurinia Pharmaceuticals has started a Phase 3 clinical trial of voclosporin, which eliminated an inflammatory kidney condition known as lupus nephritis in more than half of patients tested in a Phase 2b trial.
The complete response rate of 49 percent of the patients in the Phase 2b trial was the highest a therapy has achieved in a global study of lupus nephritis. The partial response rate to the treatment was also high: 68 percent.
The Phase 3 trial is called AURORA (NCT03021499) and the Phase 2b study AURA (NCT02141672).
Aurinia also announced that it has secured financing to continue operating until 2020. That should minimize concern that a funding crunch could sidetrack voclosporin’s development.
“I am proud of the important clinical, regulatory and financial milestones our team has successfully achieved in our first quarter this year,” Richard Glickman, Aurinia’s CEO, said in a press release.
“We released positive 48-week results” from the AURA trial, “which demonstrated significantly improved complete remission rates in patients suffering from lupus nephritis,” he said. “Furthermore, based on the results of our AURA trial and regulatory feedback, we have moved diligently into our AURORA trial, with several sites initiated” and patients currently being screened.
Aurinia presented the AURA results at the National Kidney Foundation’s spring clinical meetings in Orlando in April.
The trial met both its primary goals by eliminating lupus nephritis in 49 percent of patients treated with voclosporin and generating a partial remission in 68 percent. It also met its secondary goals, including speedy remission.
Another finding was that voclosporin’s impact was long-lasting. All patients in the low-dose treatment group who achieved complete remission at 24 weeks remained disease-free at 48 weeks.
The 320 patients in the Phase 3 AURORA trial will be randomized to receive either voclosporin or a placebo. During the study they will be tapered off the oral corticosteroids they have been taking, researchers said.
“Our clinical team is focused on continuing to initiate sites with an aggressive patient recruitment program,” Glickman said. “The AURORA trial design is consistent with that of the recently completed AURA clinical trial.”
Aurinia has now completed approval-related discussions about voclosporin with regulators in the United States, Europe and Japan.
“We believe that the totality of data from both the AURORA and AURA trials will ultimately serve as the basis for a New Drug Application (NDA) submission as well as regulatory submissions in other major global markets,” Glickman said.
The AURORA trial is expected to run until March 2020.