Aurinia Announces Presentation at 12th International Congress on SLE (LUPUS 2017) & the 7th Asian Congress on Autoimmunity (A...
March 16 2017 - 3:01PM
Business Wire
- 48-week data from open-label AURION study to
be presented on March 27, 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 the AURION
open-label study of voclosporin for the treatment of lupus
nephritis (LN) 48-week results will be presented at the 12th
International Congress on Systemic Lupus Erythematosus (LUPUS 2017)
& the 7th Asian Congress on Autoimmunity (ACA 2017) taking
place March 26-29, 2017 in Melbourne, Australia. The abstract,
titled, “AURION Study: 48-Week Data of Multi-Target Therapy with
Voclosporin, Mycophenolate Mofetil (MMF) and Steroids for Active
Lupus Nephritis,” will be presented by Robert Huizinga, Aurinia
Vice President of Clinical Affairs on March 27, 2017.
“AURION has provided early proof of concept data to support
voclosporin’s use in the treatment of active LN. “The ability to
quickly predict responses and remission rates using biomarkers can
help clinicians optimize patient care and long-term outcomes," said
Richard M. Glickman, Aurinia’s Chief Executive Officer.
The AURION study is an open-label exploratory study in 10
patients to assess the short -term predictors of response using
voclosporin (23.7mg BID) in combination with MMF and oral
corticosteroids in patients with active lupus nephritis. The
primary objective of the study is to examine biomarkers of disease
activity at eight weeks and their ability to predict response at 24
and 48 weeks. The 24-week data released in October 2016 showed a
majority of patients achieved complete remission, and all
inflammatory markers and anti-dsDNA trended towards normalization.
In addition, renal function remained stable, and voclosporin was
well-tolerated with no unexpected safety concerns observed.
Following the presentation, a copy will be available on
Aurinia’s corporate website at: www.auriniapharma.com.
About AURIONThe AURION study or “Aurinia Early Urinary
Protein Reduction Predicts Response Study” is an open-label,
exploratory study being conducted in 10 patients across two 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.
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 regulatory strategy, Aurinia's analysis, assessment and
conclusions of the results of the AURION clinical study, and the
efficacy and safety of voclosporin. 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 AURION 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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170316006249/en/
Aurinia Pharmaceuticals Inc.Investor Contact:Celia
EconomidesHead of IR &
Communicationsceconomides@auriniapharma.comorMedia
Contact:Christopher Hippolyte,
917-826-2664Christopher.hippolyte@inventivhealth.com