Aurinia Announces Preliminary Topline Data From its Open Label Aurion Study in Lupus Nephritis
February 08 2016 - 8:30AM
Business Wire
100% of Patients receiving multi-target
therapy with voclosporin achieved at least a 25% reduction of
proteinuria at 8 weeks with a mean decrease of 72%
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), 351–357.
About Aurinia
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.
About AURA:
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
non-renal SLE.
About AURION:
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.
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Aurinia Pharmaceuticals Inc.Mr. Michael Martin,
250-708-4272Chief Operating
Officermmartin@auriniapharma.comorRenmark Financial Communications
Inc.Barry Mire: bmire@renmarkfinancial.comLaura Welsh:
lwelsh@renmarkfinancial.comTel: 416-644-2020 or 514-939-3989
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