Full Press Release Details
Announces Acceptance of Voclosporin Late-Breaking Presentation at the
National Kidney Foundation 2017 Spring Clinical Meetings
Phase IIb 48-week data of voclosporin for the treatment of lupus
nephritis to be presented on April 20, 2017
VICTORIA, British Columbia--(BUSINESS WIRE)--March 6, 2017--Aurinia
Pharmaceuticals Inc. (NASDAQ:AUPH / TSX:AUP) ("Aurinia" or the
"Company"), a clinical stage biopharmaceutical company focused on the
global immunology market, today announced that its late-breaking
abstract for voclosporin has been accepted for oral presentation at the
National Kidney Foundation (NKF) 2017 Spring Clinical Meetings taking
place April 18-22, 2017 in Orlando, FL. The oral presentation, titled
"Treatment of Active Lupus Nephritis with Voclosporin: 48 Week Data from
the AURA-LV Study," will be made by lead author Dr. Samir Parikh, a
clinical investigator for the study and Assistant Professor, Clinical
Nephrology at the Ohio State University, on Thursday, April 20, 2017
from 4:00 p.m. - 5:30 p.m. ET.
A corresponding Late Breaking poster presentation of the 48-week AURA-LV
study data will also be presented at the NKF 2017 Scientific Clinical
Meetings. A copy of the abstract will be available on the conference's
website at: https://www.kidney.org/spring-clinical.
"We're pleased that the AURA-LV 48-week data have been accepted for a
late-breaking oral presentation and look forward to sharing these
important results with the nephrology scientific and medical
communities," said Richard M. Glickman, Aurinia's Chief Executive
The AURA-LV study (Aurinia Urinary
protein Reduction in Active Lupus with Voclosporin) is a 48-week study
comparing the efficacy of two doses of voclosporin added to current
standard of care of MMF against standard of care with placebo in
achieving CR in patients with active LN. All arms also received low
doses of corticosteroids as background therapy. 265 patients were
enrolled at centers in 20 countries worldwide. On entry to the study,
patients were required to have a diagnosis of LN according to
established diagnostic criteria (American College of Rheumatology) and
clinical and biopsy features indicative of highly active nephritis. The
24-week primary and secondary endpoints were released in Q3 2016 where
the primary and all secondary endpoints were met. CR is a composite
endpoint that includes: confirmed UPCR of 0.5 mg/mg; normal, stable
renal function ( 60 mL/min/1.73m2 or no confirmed
decrease from baseline in eGFR of 20%); presence of sustained, low dose
steroids ( 10mg prednisone from week 16-24); and no administration of
rescue medications. PR in the trial is measured by a 50% reduction in
UPCR with no concomitant use of rescue medication.
Voclosporin, an investigational drug,
is a novel and potentially best-in-class calcineurin inhibitor ("CNI")
with clinical data in over 2,200 patients across indications.
Voclosporin is an immunosuppressant, with a synergistic and dual
mechanism of action that has the potential to improve near- and
long-term outcomes in LN when added to standard of care (MMF). By
inhibiting calcineurin, voclosporin blocks IL-2 expression and T-cell
mediated immune responses. It is made by a modification of a single
amino acid of the cyclosporine molecule which has shown a more
predictable pharmacokinetic and pharmacodynamic relationship, an
increase in potency, an altered metabolic profile, and potential for
flat dosing. The Company anticipates that upon regulatory approval,
patent protection for voclosporin will be extended in the United States
and certain other major markets, including Europe and Japan, until at
least October 2027 under the Hatch-Waxman Act and comparable laws in
About Lupus Nephritis (LN)
LN in an inflammation of the
kidney caused by Systemic Lupus Erythematosus ("SLE") and represents a
serious progression of SLE. SLE is a chronic, complex and often
disabling disorder and affects more than 500,000 people in the United
States (mostly women). The disease is highly heterogeneous, affecting a
wide range of organs & tissue systems. It is estimated that as many as
60% of all SLE patients have clinical LN requiring treatment. Unlike
SLE, LN has straightforward disease outcomes where an early response
correlates with long-term outcomes, measured by proteinuria. In patients
with LN, renal damage results in proteinuria and/or hematuria and a
decrease in renal function as evidenced by reduced estimated glomerular
filtration rate (eGFR), and increased serum creatinine levels. LN is
debilitating and costly and if poorly controlled, LN can lead to
permanent and irreversible tissue damage within the kidney, resulting in
end-stage renal disease (ESRD), thus making LN a serious and potentially
life-threatening condition.
Aurinia is a clinical stage
biopharmaceutical company focused on developing and commercializing
therapies to treat targeted patient populations that are suffering from
serious diseases with a high unmet medical need. The company is
currently developing voclosporin, an investigational drug, for the
treatment of LN. The company is headquartered in Victoria, BC and
focuses its development efforts globally. www.auriniapharma.com
Forward Looking Statements
This press release contains
forward-looking statements, including statements related to Aurinia's
ability to execute a successful Phase III program and voclosporin
potentially shifting the treatment paradigm for LN, Aurinia's analysis,
assessment and conclusions of the results of the AURA-LV clinical study.
It is possible that such results or conclusions may change based on
further analyses of these data. Words such as "plans," "intends," "may,"
"will," "believe," and similar expressions are intended to identify
forward-looking statements. These forward-looking statements are based
upon Aurinia's current expectations. Forward-looking statements involve
risks and uncertainties. Aurinia's actual results and the timing of
events could differ materially from those anticipated in such
forward-looking statements as a result of these risks and uncertainties,
which include, without limitation, the risk that Aurinia's analyses,
assessment and conclusions of the results of the AURA-LV clinical study
set forth in this release may change based on further analyses of such
data, and the risk that Aurinia's clinical studies for voclosporin may
not lead to regulatory approval. These and other risk factors are