-Continued improvements in renal and
extra-renal outcomes
-100% of patients in complete remission at week
24 stay in complete remission at week 48 while on low-dose
voclosporin
-Renal function remained stable across both
voclosporin groups
-Live webcast at 6:15pm ET
Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH / TSX:AUP) (“Aurinia”
or the “Company”) a clinical stage biopharmaceutical company
focused on the global immunology market, today announced additional
48-week results from its global Phase IIb AURA-LV (AURA) study in
lupus nephritis (LN) during the National Kidney Foundation 2017
Spring Clinical Meetings in Orlando, FL. In addition to the trial
meeting its complete and partial remission (“CR”/”PR”) endpoints at
48 weeks, all pre-specified secondary endpoints that have been
analyzed to date were also met at 48 weeks. These pre-specified
endpoints include: time to CR and PR (speed of remission);
reduction in Systemic Lupus Erythematosus Disease Activity Index or
SLEDAI score; and reduction in urine protein creatinine ratio
(UPCR) over the 48-week treatment period. The data were presented
during the late-breaking session by lead author Dr. Samir Parikh, a
clinical investigator for the study and Assistant Professor of
Clinical Nephrology at the Ohio State University.
Each arm of the study included the current standard of care of
mycophenolate mofetil (MMF) as background therapy and a forced
steroid taper. Both doses of voclosporin at 48 weeks demonstrated
continued improvement over the control group across multiple
dimensions. Notably, the voclosporin groups demonstrated
statistically significantly improved speed and rates of CR and PR.
Of the patients that achieved CR at 24 weeks, in the low-dose
voclosporin group, 100% remained in CR at 48 weeks, which
demonstrates durability of clinical response. Proteinuria levels
and reduction in SLEDAI scores, which include non-renal measures of
lupus activity, also continued to significantly separate over time
versus the control group. Additional analyses are ongoing and will
be presented at future medical and scientific meetings.
No unexpected safety signals were observed and voclosporin was
generally well-tolerated, with the nature of adverse events
consistent with what is expected of patients suffering from highly
active LN while undergoing immunomodulation-based therapy. In the
voclosporin arms, the renal function as measured by eGFR was stable
and not significantly different from the control arm during the
48-week treatment period. Mean blood pressure was also similar
between all treatment groups.
“The most exciting aspect of this data is that voclosporin is
the first treatment candidate to successfully meet all of its
clinical endpoints in a global, prospective LN trial,” said Dr.
Samir Parikh, a clinical investigator for the study and Assistant
Professor, Clinical Nephrology at the Ohio State University.
“Voclosporin, when added to standard of care, achieved the highest
complete remission rate of any global, active LN trial, and this
was accomplished with extremely low-dose steroid exposure. The
possibility of achieving a better clinical response while avoiding
the significant side effects associated with prolonged exposure to
high dose steroids has the potential to be a game-changer in the
management of LN."
“We are pleased by the recognition of the medical and scientific
communities of the AURA study results. Beyond the remission rates
we’ve shown with voclosporin, the significant improvement in SLEDAI
scores points towards a durable, immunological effect on a broad
range of clinically meaningful lupus outcomes,” said Neil Solomons,
MD, Aurinia’s Chief Medical Officer. “This data provides us with
tremendous confidence that we can execute a successful Phase III
program and make a meaningful impact on patients’ lives.”
The 24 and 48-week efficacy results are summarized below:
Endpoint Treatment 24 weeks
P-value* 48 weeks
P-value* Complete Remission (CR) 23.7mg VCS
BID 33% p=.045 49% p<.001 39.5mg
VCS BID 27% p=.204 40% p=.026 Control Arm 19% NA 24% NA
Partial
Remission (PR) 23.7mg VCS BID 70% p=.007
69%
p=.007 39.5mg VCS BID 66% p=.024 72% p=.002 Control Arm 49%
NA 48% NA
Time to CR (TTCR) [median] 23.7mg VCS BID
19.7 weeks p<.001 19.7 weeks p<.001
39.5mg VCS BID 23.4 weeks p=.001 23.4 weeks p<.001 Control Arm
NA NA NA NA
Time to PR (TTPR) [median] 23.7mg VCS BID
4.1 weeks p=.002 4.3 weeks p=.005
39.5mg VCS BID 4.4 weeks P=.003 4.4 weeks p=.002 Control Arm 6.6
weeks NA 6.6 weeks NA
SLEDAI Reduction (non-renal lupus)
23.7mg VCS BID -6.3
p=.003 -7.9
p<.001 39.5mg VCS
BID -7.1 p=.003 -8.3 p<.001 Control Arm -4.5 NA -5.3 NA
Reduction in UPCR 23.7mg VCS BID -3.769 mg/mg
p<.001 -3.998 mg/mg p<.001 39.5mg VCS
BID -2.792 mg/mg p=.006 -2.993 mg/mg p=.008 Control Arm -2.216
mg/mg NA -2.384 mg/mg NA
*All p-values are vs control
Webcast DetailsAurinia will host a webcast today, April
20, 2017 at 6:15pm Eastern Daylight Time. A live webcast of the
event, with slides, will be available on the Investors section of
the Company’s website at
http://ir.auriniapharma.com/ir-calendar.
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 ability to execute a successful Phase III program and
voclosporin potentially shifting the treatment paradigm for LN,
Aurinia's analysis, assessment and conclusions of the results of
the AURA-LV clinical study. 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, 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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version on businesswire.com: http://www.businesswire.com/news/home/20170420006404/en/
Aurinia Pharmaceuticals Inc.Investor Contact:Celia
EconomidesHead of IR &
Communicationsceconomides@auriniapharma.comorMedia:Christopher
Hippolyte, 917-826-2664Christopher.hippolyte@inventivhealth.com
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