Aurinia Pharmaceuticals, Inc., has announced its AURA-LV clinical study has completed enrollment and will be treating a total of 265 lupus patients, surpassing its target of 258 patients.
AURA-LV (Aurinia Urine protein Reduction in Active Lupus nephritis) is a Phase 2b is randomized, controlled, double-blind clinical trial to compare the efficacy of voclosporin therapy against placebo to achieve remission in patients with lupus nephritis (LN). All enrolled patients will be given a background therapy of mycophenolate mofetil (MMF) coupled with an oral corticosteroid taper.
“Lupus nephritis is a disease with an extremely high burden of illness with no therapy approved in any major market outside of Japan,” Stephen W. Zarub, Aurinia’s President and CEO, said in a press release. “We hope that voclosporin can bring a significant improvement to the lives of patients suffering from this debilitating kidney disease.”
Voclosporin is derived from a modified single amino-acid of the cyclosporine molecule — a calcineurin inhibitor (CNI) approved for use in transplant patients since 1983. The modification is intended to produce more predictable pharmacodynamic and pharmacokinetic profiles, potential for flat dosing, and an increase in potency as compared to cyclosporine.
The AURA-LV trial will assess two doses of voclosporin given twice a day — a low oral dose (23.7 mg), and a high oral dose (39.5 mg), and its primary outcome is the number of patients achieving complete remission at 24 weeks. A secondary analyses will be made at 48 weeks, and both will include verifying markers of non-renal lupus and biomarkers.
“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” said Aurinia’s CMO, Neil Solomons, MD. “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 expects to release primary end-point results in the second half of 2016. The study’s completion date is January 2017.
The company’s open-label AURION study (Aurinia Early Urinary Protein Reduction Predicts Response Study) continues to recruit patients. The trial, taking place at sites across Malaysia, will assess the short-term predictors of response using voclosporin (23.7 mg) in combination with mycophenolate mofetil and oral corticosteroids in patients with active lupus nephritis. The study will examine biomarkers of disease activity at eight weeks and their ability to predict response at 24 and 48 weeks.