Aurinia Announces Acceptance of Voclosporin Late-Breaking Presentation at the National Kidney Foundation 2017 Spring Clinical...
March 06 2017 - 3:05PM
Business Wire
- AURA-LV Phase IIb 48-week data of
voclosporin for the treatment of lupus nephritis to be presented on
April 20, 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
Officer.
About AURA-LVThe 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.
About VoclosporinVoclosporin, 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 other countries.
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.
About AuriniaAurinia 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 StatementsThis 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 discussed
under "Risk Factors" and elsewhere in Aurinia’s Annual Information
Form for the year ended December 31, 2015 filed with Canadian
securities authorities and available at www.sedar.com and on Form
40-F with the U.S. Securities Exchange Commission and available at
www.sec.gov, each as updated by subsequent filings, including
filings on Form 6-K. Aurinia expressly disclaims any obligation or
undertaking to release publicly any updates or revisions to any
forward-looking statements contained herein to reflect any change
in Aurinia's expectations with regard thereto or any change in
events, conditions or circumstances on which any such statements
are based, except as required by law.
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Aurinia Pharmaceuticals Inc.Investor Contact:Celia
EconomidesHead of IR &
Communicationsceconomides@auriniapharma.comorMedia
Contact:Christopher Hippolyte,
917-826-2664Christopher.hippolyte@inventivhealth.com