Full Press Release Details
Announces Presentations at the European Renal Association - European
Dialysis and Transplant Association (ERA-EDTA) Meeting
VICTORIA, British Columbia--(BUSINESS WIRE)--May 12, 2016--Aurinia
Pharmaceuticals Inc. (NASDAQ:AUPH)(TSX:AUP) ("Aurinia" or the "Company")
announced three presentations including the first scientific abstract of
multi-targeted therapy (MTT) utilizing voclosporin in the treatment of
lupus nephritis at the 53rd Annual ERA-EDTA congress to be held in
Vienna, Austria from May 21st - 24th, 2016.
The first poster presentation describes the preliminary results of all
10 recruited patients on MTT using voclosporin after the first eight
weeks of therapy in the open-label AURION study. This data continues to
support the hypothesis that utilizing MTT with voclosporin has the
potential to improve the chances of achieving remission over the current
standard of care. The second poster presentation describes the potential
for an improved side-effect profile due to the pharmacokinetic
attributes of voclosporin. The final poster presentation presents data
suggesting that based on a comprehensive analysis of patients treated
with voclosporin, it has the potential to be flat dosed and may not
require therapeutic drug monitoring, making voclosporin unique within
"This data to be presented in Vienna provides increased confidence in
voclosporin's potential to improve outcomes in lupus nephritis which may
be of benefit to patients who currently have no approved therapy
available to them." said Charles Rowland, CEO of the Company.
These ERA-EDTA poster presentations will be made available on the
Company's website at http://www.auriniapharma.com/dnn/ForInvestors/CorporatePresentations.aspx
The schedule for the oral presentations are as follows:
AURION STUDY: MULTI-TARGET THERAPY WITH VOCLOSPORIN, MMF AND STEROIDS
Authors: Neil Solomons, Abdul Halim Abdul
Gafor, Rosnawati Yahya, Tak Mao Chan, Robert Huizinga
Monday, May 23 2016, 0930-1045h
Location: 53rd ERA-EDTA Congress
A CALCINEURIN INHIBITOR WITH AN IMPROVED SIDE EFFECT PROFILE?
Robert Huizinga, Neil Solomons, Mark Abel
Date/Time: Sunday, May 22
Location: 53rd ERA-EDTA Congress
CALCINEURIN INHIBITION WITHOUT THERAPEUTIC DRUG MONITORING?
Robert Huizinga, Neil Solomons, Mark Abel
Date/Time: Sunday, May 22
Location: 53rd ERA-EDTA Congress
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.
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, 416-644-2020