Aurinia Announces Presentations at the European Renal Association – European Dialysis & Transplant Association (ERA-EDTA) M...
May 12 2016 - 5:00PM
Business Wire
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 drug class.
“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 FOR LUPUS NEPHRITISAuthors: Neil
Solomons, Abdul Halim Abdul Gafor, Rosnawati Yahya, Tak Mao Chan,
Robert HuizingaDate/Time: Monday, May 23 2016, 0930-1045hLocation:
53rd ERA-EDTA CongressPresented by: Robert HuizingaAbstract:
MP130
A CALCINEURIN INHIBITOR WITH AN IMPROVED
SIDE EFFECT PROFILE?Authors: Robert Huizinga, Neil Solomons,
Mark AbelDate/Time: Sunday, May 22 2016, 0930-1045hLocation: 53rd
ERA-EDTA CongressPresented by: Robert HuizingaAbstract: SP684
CALCINEURIN INHIBITION WITHOUT THERAPEUTIC
DRUG MONITORING?Authors: Robert Huizinga, Neil Solomons, Mark
AbelDate/Time: Sunday, May 22 2016, 0930-1045hLocation: 53rd
ERA-EDTA CongressPresented by: Robert HuizingaAbstract: SP671
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 Voclosporin
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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20160512006616/en/
Aurinia Pharmaceuticals Inc.Mr. Michael Martin,
250-708-4272Chief Operating
Officermmartin@auriniapharma.comorRenmark Financial Communications
Inc.Barry Mire,
416-644-2020bmire@renmarkfinancial.comorLaura Welsh,
514-939-3989lwelsh@renmarkfinancial.com