Aurinia Presents Additional Data from Phase Iib Aura-Lv Study, Demonstrating Stable Renal Function & Blood Pressure without E...
June 05 2017 - 8:00AM
Business Wire
-Data highlight voclosporin’s additional
differentiation from its therapeutic class
Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH)(TSX:AUP) (“Aurinia”
or the “Company”) a clinical stage biopharmaceutical company
focused on the global immunology market, presented additional data
from its global Phase IIB AURA-LV (AURA) study in lupus nephritis
(LN) during the 54th European Renal Association-European Dialysis
and Transplant Association Congress (ERA-EDTA) in Madrid, Spain.
The data were presented yesterday during the late-breaking session
by lead author James Tumlin, M.D., a clinical investigator for the
study and founder of Southeast Renal Research Institute.
As previously reported, treatment with low dose voclosporin
showed statistically improved efficacy over the control arm at 24
and 48 weeks. These results were achieved in the presence of low
doses of corticosteroids. Furthermore, all key pre-specified
secondary endpoints analyzed to date were met at 48 weeks. The data
presented at ERA-EDTA demonstrated this improved efficacy was
attained while maintaining stable serum magnesium, potassium and
blood pressure levels. Well-known side effects with other
calcineurin inhibitors at their effective dose include
hypomagnesemia and hyperkalemia, which are associated with renal
impairment and require monitoring or intervention.
“We were very encouraged to observe that voclosporin therapy
resulted in significantly improved remission rates without
compromising renal function and blood pressure or inducing
electrolyte disorders,” stated Dr. Tumlin, Principal Investigator.
“Prolonged steroid therapy for lupus nephritis is associated with
unwanted side-effects, and a reduction in steroid dose should be a
treatment goal. These encouraging data suggest that voclosporin can
induce clinical remissions with low dose steroids while minimizing
renal toxicity.”
“Interestingly, voclosporin may involve a selective mechanism of
action which could explain the apparent improvement of blood
pressure at 48 weeks from baseline, stable renal function, and the
absence of hyperkalemia and hypomagnesemia over the treatment
period. Further studies are needed to delineate this potential
mechanism,” said Neil Solomons, M.D., Aurinia’s Chief Medical
Officer. “The data provides us with a high degree of confidence
that we can execute a successful Phase III program and make a
meaningful impact on patients’ lives.”
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 in speed and rates of complete and partial
remission (CR and PR, respectively). Of the low-dose voclosporin
patients that achieved CR at 24 weeks, 100% remained in CR at 48
weeks, demonstrating durability of clinical response. 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 highly 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.
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Aurinia Pharmaceuticals Inc.Investor Contact:Celia
EconomidesVice President, Public
Affairsceconomides@auriniapharma.comorMedia:Christopher
Hippolyte, 212-364-0458Christopher.hippolyte@inventivhealth.com
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