Full Press Release Details
Announces Completion of Patient Enrollment in Its Phase 2B AURA-LV Study
end-point analysis expected in approximately 28 weeks
VICTORIA, British Columbia--(BUSINESS WIRE)--January 19, 2016--Aurinia
Pharmaceuticals Inc. (NASDAQ:AUPH / TSX:AUP) ("Aurinia" or the
"Company") announced today that it has fully enrolled the AURA (Aurinia
Urine protein Reduction in Active Lupus nephritis
or AURA) study at 265 patients (target 258 patients). 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.
"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 Chief
Medical Officer Neil Solomons, M.D., "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
"Lupus nephritis is a disease with an extremely high burden of illness
with no therapy approved in any major market outside of Japan," said
Stephen W. Zaruby, president and CEO of the Company. "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.
Aurinia is a clinical stage pharmaceutical company focused on the global
nephrology market. The fully-enrolled Phase 2B AURA-LV clinical trial is
evaluating the efficacy of its lead drug, voclosporin, as a treatment
for active LN. LN is an inflammation of the kidneys, that if
inadequately treated can lead to end-stage renal disease, making LN a
serious and potentially life-threatening condition.
Voclosporin is a novel and potentially best-in-class calcineurin
inhibitor ("CNI") with extensive clinical data in over 2,000 patients in
other indications. Voclosporin is made by a modification of a single
amino acid of the cyclosporine molecule (a CNI approved for use in
transplant patients since 1983). This modification results in a more
predictable pharmacokinetic and pharmacodynamic relationship, an
increase in potency vs. cyclosporine, an altered metabolic profile, and
potential for flat dosing.
The AURA-LV study or "Aurinia Urine Protein Reduction in Active Lupus
Nephritis Study" is an adequate and well-controlled clinical trial that
enrolled 265 patients and is being conducted in over 20 countries
worldwide. This trial will compare the efficacy of voclosporin against
placebo in achieving remission in patients with active lupus nephritis.
The AURA-LV study is designed to demonstrate that voclosporin can induce
a rapid and sustained reduction of proteinuria in the presence of
extremely low steroid exposure. It will compare two dosage groups of
voclosporin (23.7mg and 39.5mg) compared to placebo, with all patients
receiving mycophenolate mofetil (MMF) and oral corticosteroids as
background therapy. There will be a primary analysis to determine
complete remission at week 24 (confirmed at 26 weeks) and various
secondary analyses at week 48 which include biomarkers and markers of
The AURION study or "Aurinia Early Urinary Protein Reduction Predicts
Response Study" is an open label, exploratory study being conducted in
multiple sites in Malaysia to assess the short term predictors of
response using voclosporin (23.7mg) in combination with mycophenolate
mofetil and oral corticosteroids in patients with active lupus
nephritis. This study will examine biomarkers of disease activity at 8
weeks and their ability to predict response at 24 and 48 weeks.
We seek Safe Harbor.
Aurinia Pharmaceuticals Inc.
Chief Operating Officer
Financial Communications Inc.
Barry Mire: bmire@renmarkfinancial.com
Welsh: lwelsh@renmarkfinancial.com
Tel: (416) 644-2020 or
Aurinia Pharmaceuticals Inc.
Zaruby, 250-708-4293
Chief Executive Officer