Aurinia Releases Open-Label AURION Data Demonstrating Increased Remission Rates over Time for Voclosporin in the Treatment of...
06 October 2016 - 11:00PM
Business Wire
- Complete remission rates increase to 70% in
the open-label study at 24 weeks-Patients in remission at eight
weeks remained in remission at 24 weeks-Data presented at the 10th
Annual European Lupus Meeting
Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH / TSX:AUP) (“Aurinia”
or the “Company”) a clinical stage biopharmaceutical company
focused on the global immunology market, today announced 24-week
data in all 10 patients from the AURION study, an open-label
exploratory study to assess the short-term predictors of response
using voclosporin (23.7mg BID) in combination with mycophenolate
mofetil (MMF) and oral corticosteroids in patients with active
lupus nephritis (LN). The data are being presented by Robert
Huizinga, Vice President of Clinical Affairs at Aurinia at the 10th
Annual European Lupus Meeting in Venice, Italy.
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.
In this study, 70% (7/10) patients achieved complete remission
(CR) at 24 weeks as measured by a urinary protein creatinine ratio
(UPCR) of ≤ 0.5mg/mg, eGFR within 20% of baseline and concomitant
steroid dose of <5mg/day. Of the 10 patients that achieved a
reduction of UPCR of ≥ 25% at 8 weeks, 80% were responders (≥ 50%
reduction in UPCR over baseline) at 24 weeks and 70% were in CR at
24 weeks. In addition, inflammatory markers such as C3, C4 and
anti-dsDNA all continued to normalize to 24 weeks. Voclosporin was
well-tolerated with no unexpected safety signals observed.
“The results of AURION provide further proof of concept data to
support voclosporin’s use in the treatment of active LN and
continue to indicate that 23.7mg BID is the optimal dose to advance
into our phase III program,” said Neil Solomons, MD, Chief Medical
Officer of Aurinia. “We are encouraged by our ability to quickly
predict responses and remission rates in these patients, which can
help clinicians optimize patient care and long-term outcomes.”
Details of the results are below:
Patient #
Attained ≥25%reduction in
UPCRat 8 weeks
Attained Partial
Remission*at 8 weeks
Attained Partial Remission*
at 24 weeks
Attained Complete Remission
at 8 weeks
Attained Complete Remission
at 24 weeks
1 Y Y Y Y Y 2 Y Y Y Y Y 3 Y Y Y N N 4 Y N N N N 5 Y Y Y Y Y 6 Y Y Y
Y Y 7 Y N N N N 8 Y Y Y Y Y 9 Y N Y N Y 10 Y Y Y N Y
TOTALS:
100% (10/10) 70%(7/10) 80% (8/10) 50%
(5/10) 70% (7/10)
*Retrospectively defined by ≥50% reduction in UPCR
About AURIONThe 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.
About VoclosporinVoclosporin, an investigational drug, is
a novel and potentially best-in-class calcineurin inhibitor (“CNI”)
with clinical data in over 2,000 patients in other 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)Lupus Nephritis (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 lupus nephritis (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 (including plans to meet with the
U.S. Food and Drug Administration to discuss these data and the
voclosporin’s subsequent clinical development and path to
registration in LN), Aurinia's analysis, assessment and conclusions
of the results of the AURION clinical study, and the efficacy and
commercial potential 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.
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Investor & Media Contact:Aurinia Pharmaceuticals
Inc.Celia EconomidesHead of IR &
Communicationsceconomides@auriniapharma.com