Aurinia Announces 24 Week Remission Rates from the First Seven Patients in its Open Label AURION Study in Lupus Nephritis (LN)
June 28 2016 - 5:45PM
Business Wire
57% (4/7) have achieved a complete remission
as measured by a urinary protein creatinine ratio of ≤ 0.5mg/mg,
eGFR within 20% of baseline and concomitant steroid dose of <
5mg/day
Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH)(TSX:AUP) (“Aurinia”
or the “Company”) announced today that it has completed an analysis
of the first 7 patients to complete 24 weeks in its open-label
AURION (Aurinia early Urinary protein Reduction Predicts
Response) study. At 24 weeks 57% (4/7) of patients continued to be
in complete remission as measured by a urinary protein creatinine
ratio of ≤ 0.5mg/mg, eGFR within 20% of baseline and concomitant
steroid dose of less than 5mg/day. Among these seven AURION
patients there was a 54% mean reduction in proteinuria at 24 weeks
compared to pre-treatment levels along with consistent improvements
in C3, C4 and anti-DS DNA. Renal function as measured by eGFR
remained stable and no new safety signals were observed.
LN is a subset of systemic lupus erythematosus and is known to
be one of the more difficult forms of this disease to treat. In
AURION the remission criteria was nearly identical to that of the
Company’s AURA study which is a 265 patient adequate and well
controlled trial that completed enrollment in January of this year.
This study is due to report primary results later this summer.
“It appears that these data continue to support the hypothesis
that biomarkers at 8 weeks can potentially predict renal response
at 24 weeks.” said Dr. Neil Solomons, MD, Chief Medical Officer of
Aurinia. “We’re seeing a reduction in disease activity that is
consistent across the biomarker panel.”
“We are encouraged by the impressive remission rates achieved in
AURION to date and look forward to releasing the AURA data later
this summer.” said Charles Rowland, Chief Executive Officer of
Aurinia. “If the AURION data is reproduced in the AURA study it may
lead to a paradigm shift in the treatment of LN patients in that
voclosporin in combination with Mycophenolate Mofetil and low dose
steroids can be used to achieve higher rates of complete remission
than existing treatment approaches.”
The Company has incorporated this data into its most recent
corporate presentation which can be found at
www.auriniapharma.com.
The Company will continue to review the AURION data and release
more information as it becomes available.
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 appears to result 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/20160628006690/en/
For More Information: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