Full Press Release Details
Announces Preliminary Topline Data From its Open Label Aurion
Study in Lupus Nephritis
of Patients receiving multi-target therapy with voclosporin achieved at
least a 25% reduction of proteinuria at 8 weeks with a mean decrease of
VICTORIA, British Columbia--(BUSINESS WIRE)--February 8, 2016--Aurinia
Pharmaceuticals Inc. (NASDAQ:AUPH / TSX:AUP) ("Aurinia" or the
"Company") announced today that it has completed a preliminary analysis
of its AURION (Aurinia early Urinary protein Reduction
Predicts Response) study. In the first seven patients that have reached
at least eight weeks of therapy in the AURION study, 100% (7/7) have
achieved at least a 25% reduction in proteinuria compared to study
entry. A 25% reduction in proteinuria has been shown to be predictive of
a positive clinical response at 24 weeks1. All of
the other pre-specified eight week biomarkers of active lupus nephritis
(LN) have also improved and are trending towards normalization. These
biomarkers have also been shown to be predictive of a positive clinical
response at 24 weeks1.
In the first eight weeks of a 48 week regimen of multi-target therapy
including voclosporin in AURION, an overall mean reduction of
proteinuria of 72% compared to pre-treatment levels was observed, and
57% (4/7) of these patients achieved complete remission as defined by a
urinary protein creatinine ratio of 0.5mg/mg. Overall renal function
as measured by eGFR in these patients has remained stable.
The AURION study is an open label, single arm, exploratory study
assessing the ability of biomarkers at 8 weeks to predict clinical
response rates at 24 and 48 weeks in subjects taking voclosporin 23.7mg
twice daily in combination with standard of care, mycophenolate mofetil
and corticosteroids, in patients with active LN.
"We are encouraged by these results. This is the first time voclosporin
has been used in this particular patient population." said Dr. Neil
Solomons, MD, Chief Medical Officer of Aurinia Pharmaceuticals Inc. "It
appears that this data supports our hypothesis that utilizing a
multi-targeted approach to treating LN with voclosporin can help
patients suffering from this disease. We are very excited to see the
results from the 265 patient AURA study later this year."
The Company will continue to review the AURION data and release more
information as it becomes available, a webcast has been scheduled for
Tuesday February 16th, 2016 at 4:30pm Eastern Standard Time.
Interested parties can join the webcast at the specified time at the
following URL: http://public.viavid.com/index.php?id=118297
1Dall'Era, M., Stone, D., Levesque, V., Cisternas,M., &
Wofsy, D. (2011).Arthritis Care and Research, 63(3),
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