Aurinia enrolls 265 patients in AURA study of voclosporin in active lupus nephritis

This Phase 2B study, is a randomized, controlled, double-blind study comparing the efficacy of voclosporin as a component of multi-targeted therapy against placebo in achieving remission in patients with active lupus nephritis (LN).

AURA is one of the largest prospective registration-quality studies ever conducted within this specific disease area.

The AURA study has been designed to demonstrate that voclosporin can induce a rapid and sustained reduction of proteinuria with extremely low steroid exposure. The placebo-controlled study assesses two doses of voclosporin, with all patients receiving background therapy of mycophenolate mofetil (MMF) coupled with an aggressive oral corticosteroid taper.

There will be a primary analysis to determine complete remission at week 24 (confirmed at 26 weeks) and various secondary analyses at both 24 and 48 weeks which include biomarkers and markers of non-renal lupus.

Aurinia chief medical officer Neil Solomons said: "This disease has shown to be particularly difficult to treat with fewer than 20% of patients achieving clinical remission at six months on existing regimens which often require unacceptably high steroid exposure in this predominantly young, female population.

"We would like to thank the investigators, site coordinators and patients who are participating in this study in more than 20 countries around the world. Their involvement will provide invaluable information for those patients suffering from LN."

Aurinia president and CEO Stephen Zaruby said: "Lupus nephritis is a disease with an extremely high burden of illness with no therapy approved in any major market outside of Japan.

"We hope that voclosporin can bring a significant improvement to the lives of patients suffering from this debilitating kidney disease."

The Company anticipates that the primary end-point results of the AURA study will be released in Q3 this year. The Company also continues to recruit patients into its open label AURION study and expects to review data in the near future.