AURA-LV Phase IIb Study Meets 48-Week
Remission Endpoints, Achieving Highest Complete Remission Rate of
Any Global Lupus Nephritis Study
48-Week AURA-LV Data to be presented in Late
Breaker Presentation at National Kidney Foundation 2017 Scientific
Clinical Meetings
AURORA Phase III Trial with Voclosporin on
Track to Commence Q2 2017
Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH-TSX:AUP) (“Aurinia” or
the “Company”) has released its financial results for the fourth
quarter and year ended December 31, 2016. Amounts, unless specified
otherwise, are expressed in U.S. dollars.
Aurinia plans to initiate a single, Phase III clinical trial
(“AURORA”) whose design is consistent with that of the ongoing
AURA-LV (“AURA”) clinical trial. The totality of data from both the
AURORA and AURA trials will serve as the basis for a New Drug
Application (NDA) submission following completion of the Phase III
trial. The Company continues to focus its efforts on finalizing the
study protocol and regulatory submissions in parallel with site
selection, making the necessary investments now to ensure the team
has the tools to execute a successful clinical trial.
“I am proud of the important milestones our team has reached
over the past several months, including our most recent and
significant achievement to date, the promising 48-week results from
our AURA study of voclosporin, demonstrating significantly improved
long-term outcomes for patients suffering from lupus nephritis,”
said Richard Glickman, Aurinia CEO and Chairman of the Board. “The
recent news that our late-breaking abstract for voclosporin has
been accepted for oral presentation at the National Kidney
Foundation 2017 Scientific Clinical Meetings underscores the
importance of this compelling dataset. We remain committed to
advancing voclosporin with the end goal of improving the lives of
patients impacted by this devastating disease, and potentially
altering the treatment paradigm of lupus nephritis.”
Recent operational highlights
AURA 48-Week Results
On March 1, 2017, the Company announced top-line results from
its AURA study in lupus nephritis (LN). At 48 weeks, the trial met
the complete and partial remission (“CR”/”PR”) endpoints,
demonstrating statistically significant 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, including in a late breaker presentation at the National
Kidney Foundation 2017 Scientific Clinical Meetings April 18-22,
2017 in Orlando, FL.
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 32.6% 2.03
p=.045 49.4% 3.21
p<.001 39.5mg VCS BID 27.3%
1.59 p=.204 39.8%
2.10
p=.026 Control Arm
19.3% NA NA 23.9%
NA NA
PartialRemission
23.7mg VCS BID 69.7% 2.33
p=.007 68.4% 2.34
p=.007 39.5mg VCS BID 65.9% 2.03
p=.024 71.6% 2.68
p=.002 Control Arm 49.4%
NA NA 48.3%
NA NA
*All p-values are vs control
Japanese Phase I Ethnic Bridging Study for
Voclosporin
On February 14, 2017, the Company announced results of a
supportive Phase I safety, pharmacokinetic (PK) and
pharmacodynamics (PD) study in healthy Japanese patients, which
supports further development of voclosporin in this patient
population. Based on evaluations comparing the Japanese
ethno-bridging data vs. previous PK and PD studies in non-Japanese
patients, voclosporin demonstrated no statistically significant
differences in exposure with respect to Area Under the Curve (AUC)
measurements. Furthermore, the PK parameters in Japanese patients
were generally consistent with previously evaluated PK parameters
in non-Japanese volunteers. There were no unusual or unexpected
safety signals in the study. The Company plans to share its
findings with the Japanese Pharmaceuticals and Medical Devices
Agency (“PMDA”) in Q2 2017 and determine a path forward for
regulatory submission in Japan.
Long-Term Manufacturing Agreement with Lonza
In Q4 2016, Aurinia announced a long-term agreement with Lonza
for the manufacture of voclosporin active pharmaceutical ingredient
(API). The agreement followed a successful multi-year clinical
manufacturing relationship where the companies had refined the
process and analytical methods to produce clinical and commercial
supplies of voclosporin. Under the terms of the agreement, Lonza
agreed to produce cGMP-grade voclosporin drug substance for use in
the AURORA trial and for future commercial use. The agreement also
provides an option to have Lonza exclusively supply API for up to
20 years.
The Company expects the following additional milestones and
events in the first half of 2017:
- Late breaking presentation of AURA
48-week results at the National Kidney Foundation 2017 Scientific
Clinical Meetings;
- Outcome of European Medicines Agency
(EMA) and PMDA discussions
- AURION open label study 48-week
results;
- Initiation of Phase III AURORA
trial.
Financial results for the year ended December 31,
2016
For the year ended December 31, 2016, the Company recorded a
consolidated net loss of $23.3 million or $0.66 per common share,
as compared to a consolidated net loss of $18.6 million or $0.58
per common share in 2015.
The increase in the reported consolidated net loss was primarily
attributable to recording a non-cash gain of $1.7 million in 2016
on the fair value revaluation of the derivative warrant liability
compared to a gain of $5.1 million in the same period in 2015.
After adjusting for the non-cash impact of the revaluation of
the derivative warrant liability, the net loss from operations for
the year ended December 31, 2016 was $25.0 million compared to
$23.7 million for the corresponding period in 2015.
The Company incurred net research and development expenditures
of $14.5 million for the year ended December 31, 2016, as compared
to $16.0 million for the same period in 2015. Research and
development expenditures included planning, regulatory, site
selection costs and drug manufacturing related to the planned Phase
III LN clinical trial, clinical costs related to completing the
AURA trial and costs related to conducting the Japanese PK study.
Research and development expenditures in 2015 reflected higher
costs incurred for the AURA trial including drug distribution,
patient recruitment, enrollment and treatment activities.
The Company incurred corporate, administration and business
development expenditures of $7.0 million for the year ended
December 31, 2016, as compared with $6.3 million for the same
period in fiscal 2015.
Other expense (income) reflected a net expense of $2.2 million
for the year ended December 31, 2016 compared to a net expense of
$128,000 for 2015. The Company recorded as other expense, a
revaluation adjustment on contingent consideration to ILJIN Life
Science Co., Ltd. in the amount of $1.6 million in 2016 compared to
$337,000 in 2015. The Company also recorded an expense of $655,000
in other expense (income) related to share issue costs allocated to
derivative warrants incurred to complete the December 28, 2016
bought deal public offering.
Financial results for the fourth quarter ended December 31,
2016
The Company reported a consolidated net loss of $8.3 million or
$0.21 per common share for the three months ended December 31,
2016, as compared to a consolidated net loss of $4.1 million or
$0.13 per common share for the three months ended December 31,
2015. The increased loss was attributable to increased expenditures
for both research and development and corporate activities as we
were finishing the AURA trial while also commencing set up
activities for the AURORA trial including drug manufacturing, CRO,
and country and site selections.
The increase in the consolidated net loss also reflected a
reduction in the fair value adjustment gain on derivative warrant
liabilities to $658,000 in the fourth quarter of 2016 from a gain
of $1.5 million in the comparable period in 2015 and the $655,000
in share issue costs discussed above.
Research and development expenses increased to $5.5 million in
the fourth quarter of 2016, compared to $3.7 million in the fourth
quarter of 2015 as the Company ramped up activities required for
commencing the planned AURORA clinical trial in the second quarter
of 2017.
Corporate and administration expenses also increased to $2.2
million for the fourth quarter of 2016, compared to $1.6 million
for the fourth quarter of 2015, reflecting increased activities
related to investor relations, patient advocacy and market
research.
Financial Liquidity
In 2016, the Company raised net proceeds of $40.6 million from
equity financings and received $2.0 million from the exercise of
warrants and options. As a result, at December 31, 2016 the Company
had cash of $39.6 million and working capital of $33.5 million.
The audited financial statements and the Management's Discussion
and Analysis for the year ended December 31, 2016, are accessible
on Aurinia's website at www.auriniapharma.com, on SEDAR at
www.sedar.com or on EDGAR at www.sec.gov/edgar.
Forward-Looking Statements
This press release contains forward-looking statements,
including statements around Aurinia's analysis, assessment and
conclusions around the future development and commercial potential
of voclosporin; the benefits of FDA fast track designation and the
timing of future clinical trials; summary statements relating to
results of the past voclosporin trials; the timing of commencement
and completion of clinical trials; the timing of the Company’s
anticipated milestones for 2017; and plans and objectives of
management.
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 future development and commercial potential of voclosporin 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.
Such forward-looking statements involve known and unknown risks,
uncertainties, and other factors that may cause the Company’s
actual results, performance, or achievements to differ materially
from any further results, performance or achievements expressed or
implied by such forward-looking statements. Important factors that
could cause such differences include, among other things, the
following:
- the need for additional capital to fund
the Company’s development programs and the effect of capital market
conditions and other factors on capital availability;
- difficulties, delays, or failures the
Company may experience in the conduct of its planned AURORA
clinical trial;
- difficulties, delays or failures in
obtaining regulatory approvals for the initiation of clinical
trials;
- difficulties the Company may experience
in completing the development and commercialization of
voclosporin;
Although the Company believes that the expectations reflected in
the forward-looking statements are reasonable, the Company cannot
guarantee future results, levels of activity, performance or
achievements. These forward-looking statements are made as of the
date hereof.
We seek Safe Harbor.
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Aurinia Pharmaceuticals Inc.Investor &
Media:Celia EconomidesHead of IR &
Communicationsceconomides@auriniapharma.comorChief Financial
Officer:Dennis Bourgeault, 780-643-2260780-484-4105
(fax)dbourgeault@auriniapharma.com