Aurinia Highlights 48-Week Data from Open-Label AURION Study at 12th International Congress on SLE (LUPUS 2017) & the 7th Asi...
March 27 2017 - 02:30AM
Business Wire
-Biomarkers of disease activity at eight weeks
can predict renal response at 24 and 48 weeks
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
48-week results from the “Aurinia Early Urinary Protein Reduction
Predicts Response Study” (AURION) open-label study of voclosporin
for the treatment of lupus nephritis (LN) at the 12th International
Congress on Systemic Lupus Erythematosus and 7th Asian Congress on
Autoimmunity jointly in Melbourne, Australia. The data were
presented by Robert B. Huizinga, Vice President of Clinical Affairs
at Aurinia.
The study successfully achieved its primary objective by
demonstrating that early biomarker response in active LN patients
can be a significant predictor of renal response at 24 and 48
weeks.
In the per protocol analysis at 48 weeks, 71% of subjects
(n=5/7) on treatment remain in complete remission 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. A 25%
reduction in UPCR at week eight was found to be highly predictive
of achieving renal response at 24 and 48 weeks. Conversely, if C3
and C4 do not normalize by week 8, then a renal response at week 24
and 48 is highly unlikely. Anti-dsDNA was not found to be a useful
biomarker in predicting long-term response in LN patients.
No new safety signals were observed with the use of voclosporin
in LN patients; voclosporin was well-tolerated, and the safety
profile was consistent with other immunomodulators. A total of
three subjects were discontinued prior to 48 weeks due to lupus
related complications or Investigator discretion.
“Results from AURION demonstrated that an early UPCR reduction
of 25% is the best predictor of renal response at 24 and 48 weeks,”
said Neil Solomons, MD, Chief Medical Officer at Aurinia. “In
addition, the use of C3 or C4 improves the precision of predicting
if a patient will achieve a clinical response. This exploratory
study is supportive of the successful AURA Phase 2b study and
continues to inform us of optimal ways to evaluate renal response
in future LN trials.”
About AURIONThe AURION study or “Aurinia Early Urinary
Protein Reduction Predicts Response Study” is an open-label,
exploratory study being conducted in 10 patients in 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 AURA-LV 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 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.
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Investors:Celia EconomidesHead of IR &
Communicationsceconomides@auriniapharma.comorMedia:Christopher
Hippolyte, 212-364-0458Christopher.hippolyte@inventivhealth.com