- Low dose voclosporin achieves CR rate of
49.4% at 48 weeks (p<.001)
- AURORA Phase III trial with low dose
voclosporin on track to commence in Q2 2017
- Conference call & webcast 8:30am ET
tomorrow
Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH / TSX:AUP) (“Aurinia”
or the “Company”), a clinical stage biopharmaceutical company
focused on the global immunology market, today announced top-line
results from its Phase IIb AURA-LV (AURA) study in lupus nephritis
(LN). At 48 weeks, the trial met the complete and partial remission
(“CR”/ “PR”) endpoints, demonstrating statistically significantly
greater CR and PR in patients in both low dose (23.7mg of
voclosporin twice daily (p<.001)) and high dose (39.5mg twice
daily (p=.026)) cohorts versus the control group.
Each arm of the study included the current standard of care of
mycophenolate mofetil (MMF) as background therapy and a forced
steroid taper to 5mg/day by week 8 and 2.5mg by week 16. No
unexpected safety signals were observed and there were no
additional deaths in the voclosporin treated patients; however,
there were three deaths and one malignancy reported in the control
arm after completion of the study treatment period. Additional data
analyses for the AURA study at 48 weeks will be released at future
corporate, medical and scientific meetings.
“Lupus nephritis (LN) is one of the most severe complications of
systemic lupus erythematosus. The current treatments of LN are
toxic and the complete renal response rates are unacceptably low.
For the last several years the community of lupus researchers in
collaboration with the pharmaceutical industry have been engaged in
finding more effective therapies for LN, but success has been
difficult to achieve,” said Brad Rovin, MD, FASN, Director of
Nephrology and Vice Chairman of Research for the Department of
Internal Medicine at the Ohio State University Wexner Medical
Center. “The AURA trial’s long-term results convincingly
demonstrate that the addition of voclosporin to standard of care
treatment is superior to standard of care alone. These data are not
only statistically significant, but clinically important. Twice as
many patients given 23.7mg voclosporin twice daily achieved a
complete renal response compared to those treated with placebo.
This is an impressive renal response rate and these results may
shift the treatment paradigm of LN. Based on these encouraging
data, I am looking forward to the Phase III trial of voclosporin in
LN.”
The 24 and 48-week top-line efficacy results
are summarized below:
Endpoint Treatment 24 weeks
Odds ratio P-value* 48
weeks Odds Ratio P-value*
CompleteRemission
23.7mg VCS BID 33% 2.03 p=.045 49% 3.21
p<.001 39.5mg VCS
BID 27% 1.59 p=.204 40% 2.10
p=.026 Control Arm 19% NA NA
24% NA NA Partial Remission 23.7mg VCS BID 70% 2.33 p=.007 68% 2.34
p=.007 39.5mg VCS BID 66% 2.03 p=.024 72% 2.68
p=.002
Control Arm 49% NA NA 48% NA NA
*All p-values are vs control
“We are grateful to both the patients and investigators who have
worked with us on this groundbreaking program. Voclosporin is the
first and only treatment candidate that has demonstrated such a
clear treatment effect for LN patients,” said Neil Solomons, MD,
Aurinia’s Chief Medical Officer. “These data provide us with
tremendous confidence that we can execute a successful Phase III
program and make a meaningful impact on patients’ lives.”
“Lupus nephritis carries with it life-threatening complications,
including kidney failure. The treatment of the disease is
challenging, and steroid side-effects are often difficult for
patients to endure. The National Kidney Foundation supports
the development of steroid-sparing treatment options, and we look
forward to following the results of the Phase III trial,” said
Joseph Vassalotti, MD, Chief Medical Officer, National Kidney
Foundation.
Conference Call and Webcast DetailsAurinia will host a
conference call and webcast tomorrow, March 2, 2017 at 8:30am
Eastern Standard Time to provide an overview of the AURA 48-week
top-line results. In order to participate in the conference call,
please dial +1-877-407-9170 (Toll-free U.S. & Canada). An audio
webcast can be accessed under "News/Events” through the “Investors”
section of the Aurinia corporate website
at www.auriniapharma.com. A replay of the webcast will be
available on Aurinia’s website.
About AURA-LVThe AURA–LV study (Aurinia Urinary protein
Reduction in Active Lupus with Voclosporin) is a 48-week study
comparing the efficacy of two doses of voclosporin added to current
standard of care of MMF against standard of care with placebo in
achieving CR in patients with active LN. All arms also received low
doses of corticosteroids as background therapy. 265 patients were
enrolled at centers in 20 countries worldwide. On entry to the
study, patients were required to have a diagnosis of LN according
to established diagnostic criteria (American College of
Rheumatology) and clinical and biopsy features indicative of highly
active nephritis. The 24-week primary and secondary endpoints were
released in Q3 2016 where the primary and all secondary endpoints
were met. CR is a composite endpoint that includes: confirmed UPCR
of ≤0.5 mg/mg; normal, stable renal function (≥60 mL/min/1.73m2 or
no confirmed decrease from baseline in eGFR of ≥20%); presence of
sustained, low dose steroids (≤10mg prednisone from week 16-24);
and no administration of rescue medications. PR in the trial is
measured by a ≥50% reduction in UPCR with no concomitant use of
rescue medication.
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, 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, except as required by law.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170301006343/en/
Aurinia Pharmaceuticals Inc.Investor Contact:Celia
EconomidesHead of IR &
Communicationsceconomides@auriniapharma.comorMedia
Contact:Christopher Hippolyte,
917-826-2664Christopher.hippolyte@inventivhealth.com