AURA first global clinical trial in lupus
nephritis that meets primary and all secondary endpoints
AURION 24-week results support the use of
voclosporin for the treatment of lupus nephritis
Successful completion of EOP2 meeting with
FDA
Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH)(TSX:AUP) (“Aurinia”
or the “Company”) has released its financial results for the third
quarter ended September 30, 2016. Amounts, unless specified
otherwise, are expressed in U.S. dollars.
Aurinia plans to initiate a single, Phase 3 clinical trial
(AURORA) whose design is consistent with that of the ongoing AURA
clinical trial. The totality of data from both trials will serve as
the basis for a New Drug Application (NDA) submission following
completion of the Phase 3 trial, and the Company is focusing 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.
“We have made exceptional progress over the last few months
announcing the first global clinical trial in LN to meet its
primary and all secondary endpoints,” said Charles Rowland, CEO of
Aurinia Pharmaceuticals. “Additionally, the recent selection of the
AURA Phase 2b results for late-breaking presentations by the
American College of Rheumatology (ACR) and American Society of
Nephrology (ASN) is a testament to the hard work executed by our
world-class clinical team. We look forward to advancing voclosporin
into Phase 3 for the treatment of LN and pursuing our goal of
helping patients living with this devastating disease.”
Operational Highlights
FDA End of Phase 2 Meeting Update
On November 2, 2016, the Company announced its plans for a
single Phase 3 clinical trial for voclosporin in the treatment of
lupus nephritis (LN). Pursuant to its recent End of Phase 2 meeting
with the U.S. Food & Drug Administration (FDA) Division of
Pulmonary, Allergy and Rheumatology Products, Aurinia believes this
Phase 3 clinical trial whose design is consistent with the ongoing
AURA study, will support a New Drug Application (NDA) submission.
Preparations are underway for the Phase 3 AURORA trial, which is
planned to initiate in Q2 2017.
AURA Phase 2b Clinical Trial Update
On August 15, 2016, the Company announced positive top-line
results for the AURA clinical trial. The trial met its primary
endpoint, with voclosporin 23.7mg BID showing a statistically
significant improvement (p=.045) in complete remission (CR). Each
arm of the trial included the current standard of care of
mycophenolate mofetil (MMF) as background therapy and a forced
steroid taper to 5 mg/day by week 8 and 2.5 mg by week 16. No
unexpected safety signals were observed and voclosporin was shown
to be well tolerated.
On September 30, 2016, the Company announced that in addition to
achieving its primary endpoint, voclosporin also met all 24-week
pre-specified secondary endpoints in the Phase 2b AURA clinical
trial for LN.
Pre-specified Secondary Endpoint Control
Low Dose VCS
(23.7mg BID)
High Dose VCS
(39.5mg BID)
Time to Complete Remission (TTCR)
[median]
Not achieved 19.7 weeks 23.4 weeks
p<.001 p=.001
Partial Remission (as measured
byUPCR reduction of ≥ 50% from baseline)
49% 70% 66%
p=.007 p=.024
Time to Partial Remission (TTPR)
[median]
6.6 weeks 4.1 weeks 4.4 weeks
p=.002 p=.003 SLEDAI
Reduction -4.5 -6.3 -7.1
p=.003 p=.003
Reduction in UPCR -2.216 mg/mg -3.769 mg/mg -2.792 mg/mg
p<.001 p=.006
AURION Clinical Trial Update
On October 6, 2016 the Company announced results from all 10
patients at 24 weeks of the ongoing open-label AURION clinical
trial. In this clinical trial, 70% (7/10) patients achieved
complete remission (CR) at 24 weeks as measured by a urinary
protein creatinine ratio (UPCR) of ≤ 0.5mg/mg, eGFR within 20% of
baseline and concomitant steroid dose of <5mg/day. Of the 10
patients that achieved a reduction of UPCR of ≥ 25% at 8 weeks, 80%
were responders (≥ 50% reduction in UPCR over baseline) at 24 weeks
and 70% were in CR at 24 weeks. In addition, C3, C4, anti-dsDNA all
continued to normalize to 24 weeks. Voclosporin was well-tolerated
with no unexpected safety signals observed.
Initiation of Phase 1 Japanese Study
The Company has initiated discussions with the Japanese
regulatory authorities to understand their perspective on gaining
approval for voclosporin in their jurisdiction. The Company’s goal
will be to obtain their acceptance of the same development plan as
reviewed with FDA. To that end, the Company, in October of 2016,
has initiated a Phase 1 study in healthy Japanese volunteers to
permit Japanese sites to potentially participate in the Phase 3
trial.
The Company expects the following milestones and events for
the rest of 2016 and first half of 2017:
- Late breaking presentations at the
American College of Rheumatology (ACR) and the American Society of
Nephrology (ASN);
- Meetings with European Medicines Agency
(EMA) and Pharmaceutical & Medical Devices Agency, Japan
(PMDA);
- AURA 48-week secondary endpoint
results;
- AURION 48-week results;
- Initiation of Phase 3 program.
At the Market (ATM) Facility
On July 22, 2016 the Company entered into a Controlled Equity
Offering Sales Agreement with Cantor Fitzgerald & Co. (“Cantor
Fitzgerald”) pursuant to which the Company was able to, from time
to time, sell common shares through at-the-market (“ATM”) offerings
with Cantor Fitzgerald acting as sales agent.
As of October 3, 2016, sales pursuant to the ATM were concluded.
The Company issued 3.3 million common shares, receiving gross
proceeds of $8 million ($6.1 million in the third quarter of 2016
and $1.9 million subsequent to the quarter end) which was the
maximum allowable pursuant to the limit imposed by Toronto Stock
Exchange rules.
Financial Results for the Third Quarter Ended September 30,
2016
The Company had cash, cash equivalents and short term
investments of $15.4 million at September 30, 2016 compared to
$12.1 million at June 30, 2016 and $15.8 million at December 31,
2015. Net cash used in operating activities was $5.0 million for
the third quarter ended September 30, 2016. The Company generated
$7.4 million from financing activities during the quarter resulting
from net proceeds of $5.7 million received from the issue of common
shares pursuant to the ATM facility and $1.7 million from warrant
and option exercises in the third quarter of 2016.
For the third quarter ended September 30, 2016, the Company
reported a consolidated net loss of $7.4 million or $0.21 per
common share, as compared to a consolidated net loss of $5.2
million or $0.16 per common share for the same period in 2015. The
increase in the reported consolidated net loss was primarily
attributable to recording a non-cash loss of $951,000 on the
quarterly fair value revaluation of the derivative warrant
liability compared to a gain of $1.2 million to the same period in
2015.
For the nine months ended September 30, 2016, the consolidated
net loss was $15.0 million or $0.44 per common share compared to a
consolidated net loss of $14.5 million or $0.45 per common share
for the comparable period in 2015.
Research and development expenses decreased to $3.3 million for
the three months ended September 30, 2016, compared to $4.7 million
for the three months ended September 30, 2015. The Company incurred
net research and development expenditures of $9.1 million for the
nine months ended September 30, 2016, as compared to $12.3 million
for the same period in 2015. The decrease is primarily the result
of a reduction of ongoing costs related to the active patient
portion of the AURA clinical trial as patients complete the
trial.
Corporate, administration and business development expenses
increased to $1.7 million for the three months ended September 30,
2016, compared to $1.4 million for the same period in 2015. The
Company incurred corporate, administration and business development
expenses of $4.7 million for the nine months ended September 30,
2016 compared to $4.7 million for the same period in 2015.
The unaudited interim condensed consolidated financial
statements and the MD&A for the third quarter ended September
30, 2016 are accessible on Aurinia's website at
www.auriniapharma.com or on SEDAR at www.sedar.com or on EDGAR at
www.sec.gov/edgar.
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 lupus
nephritis (LN). The Company is headquartered in Victoria, BC.
Canada and focuses its development efforts globally.
About AURA:
The AURA–LV clinical trial (Aurinia
Urine protein Reduction in Active
Lupus with voclosporin) is a 48-week clinical trial comparing the
efficacy of two doses of voclosporin added to current standard of
care of MMF against standard of care with placebo in achieving
complete remission (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 trial, 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 with 48-week secondary endpoint
results to be announced in Q1 2017.
About AURION:
The AURION clinical trial or “Aurinia Early Urinary
Protein Reduction Predicts Response Study” is an open-label,
exploratory study being conducted in two sites in Malaysia to
assess the short term predictors of response using voclosporin
(23.7mg) in combination with mycophenolate mofetil and oral
corticosteroids in patients with active lupus nephritis. This study
will examine biomarkers of disease activity at 8 weeks and their
ability to predict response at 24 and 48 weeks.
About AURORA:
The AURORA study is a 52-week global double-blind placebo
controlled phase 3 study that will compare the efficacy of one dose
of voclosporin (23.7mg BID) or placebo added to current standard of
care of mycophenolate mofetil (MMF, also known as CellCept®) in
achieving renal response (formerly referred to as complete
remission) in patients with active LN. Both arms will also receive
low doses of corticosteroids as part of background therapy after a
stringent taper.
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 2016 and 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, 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.
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 and reporting of results
of its clinical trials for voclosporin, and in particular its
current AURA 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
Contact:Celia EconomidesHead of IR &
Communicationsceconomides@auriniapharma.comorChief Financial
Officer:Dennis Bourgeault, 780-643-2260Fax:
780-484-4105dbourgeault@auriniapharma.com