-Patients on voclosporin achieve remission
faster and maintain remission longer when compared to control
-Data presented during late-breaking
session
Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) (“Aurinia”
or the “Company”) a clinical stage biopharmaceutical company
focused on the global immunology market, presented new duration of
remission data from its global Phase IIB AURA-LV (AURA) study in
lupus nephritis (LN) during the Annual European Congress of
Rheumatology (EULAR) 2017 in Madrid, Spain. The presentation was
made during the late-breaking session by Prof. Vladimir A.
Dobronravov, MD, PhD, DSc, a clinical investigator for the study
and Vice Director, Research Institute of Nephrology, 1st
St-Petersburg Pavlov State Medical University.
As previously reported, treatment with low dose voclosporin
showed statistically improved efficacy over the control arm at both
24 and 48 weeks, with a doubling of remission rates at 48 weeks
versus the control arm (49% vs 24%). These results were achieved in
the presence of low doses of corticosteroids and normal, stable
renal function. Furthermore, of the low-dose voclosporin patients
that achieved CR at 24 weeks, 100% remained in CR at 48 weeks,
establishing durability of clinical response. The data presented at
EULAR 2017 demonstrated that over the course of the 48-week trial,
patients on voclosporin stayed in remission approximately twice the
amount of time as those in the control group. These differences
were statistically significant versus the control arm. Duration of
remission as measured by proteinuria is clinically meaningful as it
may correlate with lower rates of progression to Chronic Kidney
Disease.1
The remission results at 48 weeks are summarized below.
Treatment Group Complete
Remission
Duration of Remission through48
weeks (mean days, 95%CI)(measured by UPCR ≤.5mg/mg)
VCS 23.7mg BID 49%
123 (96.1,148.4)
p<.001 p=.0012 VCS 39.5mg
BID 40% 111
(82.7,129.7) p=.026 p=.01
Control Group 24%
66 (43.0,88.5) NA NA
“Not only have more patients on voclosporin achieved complete
remission, but they have done so faster. Patients on low-dose
voclosporin are also maintaining remission for a longer
duration—nearly twice that of the control group on average,” stated
Dr. Dobronravov. “The quicker we can bring patients into remission
and keep them there, the more likely we are to delay or even
prevent the deleterious effects of prolonged inflammation which can
lead to irreversible kidney damage.”
All arms of the study included the current standard of care of
mycophenolate mofetil (MMF) as background therapy and an aggressive
steroid taper. Both doses of voclosporin at 48 weeks demonstrated
continued improvement over the control group across multiple
measures. The voclosporin treated groups demonstrated statistically
significant improvement over the control group in speed and rates
of complete and partial remission (CR and PR, respectively).
Proteinuria levels and reduction in Systemic Lupus Erythematosus
Disease Activity Index (SLEDAI) scores, which include non-renal
measures of lupus activity, also continued to significantly improve
over time versus the control group. Additional analyses are ongoing
and will be presented at future medical and scientific
meetings.
No unexpected safety signals nor adverse events were observed
and voclosporin was generally well-tolerated, consistent with what
is expected of patients suffering from active LN while undergoing
immunomodulation-based therapy. In the voclosporin arms, renal
function as measured by estimated glomerular filtration rate (eGFR)
was stable and not significantly different from the control arm
following the 48-week treatment period. There were no electrolyte
changes in the treatment groups and mean blood pressure was also
similar across treatment groups through 48 weeks.
About Voclosporin
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 has been shown to have a more predictable
pharmacokinetic and pharmacodynamic relationship, an increase in
potency, an altered metabolic profile and potential for flat dosing
compared to legacy CNIs. 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 percent of
all SLE patients will develop clinical LN requiring treatment.
Unlike SLE, LN has straightforward disease outcomes (measuring
proteinuria) where an early response correlates with long-term
outcomes. 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 Aurinia
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’s potential
differentiation from its therapeutic class, Aurinia's analysis,
assessment and conclusions of the results of the AURA-LV clinical
study and timing of voclosporin’s patent protection. 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, the future success of a Phase III study and the timing of
voclosporin’s patent protection 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, 2016 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.
1Kidney Int. 2011 Apr;79(8):914-20. doi:
10.1038/ki.2010.525. Epub 2011 Jan 19.
Persistent proteinuria and dyslipidemia increase the risk of
progressive chronic kidney disease in lupus
erythematosus.
Reich HN1, Gladman DD, Urowitz MB, Bargman
JM, Hladunewich MA, Lou W, Fan SC, Su
J, Herzenberg AM, Cattran DC, Wither
J, Landolt-Marticorena C, Scholey JW, Fortin PR.
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Aurinia Pharmaceuticals Inc.Investors:Celia
EconomidesVice President, Public
Affairsceconomides@auriniapharma.comorMedia:Christopher
Hippolyte, 212-364-0458Christopher.hippolyte@inventivhealth.com