Full Press Release Details
Announces 24 Week Remission Rates from the First Seven Patients in its
Open Label AURION Study in Lupus Nephritis (LN)
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
VICTORIA, British Columbia--(BUSINESS WIRE)--June 28, 2016--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.
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.
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.
For More Information:
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