Full Press Release Details
Reports Fourth Quarter and Full Year 2015 Financial Results and Recent
Operational Highlights
VICTORIA, British Columbia--(BUSINESS WIRE)--March 18, 2016--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, 2015. Amounts, unless specified otherwise, are expressed in
Recent operational highlights
Aura-LV (AURA) Phase 2b clinical trial update- Patient enrollment
On January 19, 2016, the Company announced completion of patient
enrollment of its AURA (Aurinia Urinary
protein Reduction in Active
lupus nephritis or AURA) clinical trial at 265 patients (target 258
patients). This Phase 2b trial, is a randomized, controlled,
double-blind study comparing the efficacy of voclosporin as a component
of multi-targeted therapy against placebo in achieving remission in
patients with active lupus nephritis (LN). AURA is one of the largest
prospective registration-quality studies ever conducted within this
specific disease area.
The AURA trial has been designed to demonstrate that voclosporin can
induce a rapid and sustained reduction of proteinuria with extremely low
steroid exposure. The placebo-controlled trial assesses two doses of
voclosporin, with all patients receiving background therapy of
mycophenolate mofetil (MMF) coupled with an aggressive oral
corticosteroid taper. There will be a primary analysis to determine
complete remission at week 24 (confirmed at 26 weeks) and various
secondary analyses at both 24 and 48 weeks which include biomarkers and
markers of non-renal lupus. This disease has shown to be particularly
difficult to treat with fewer than 20% of patients achieving clinical
remission at six months on existing regimens which often require
unacceptably high steroid exposure in this predominantly young, female
On February 8, 2016 the Company announced that it had completed a
preliminary analysis of its AURION (Aurinia early Urinary
protein Reduction Predicts Response) study. In the first
seven patients that have reached at least eight weeks of therapy in the
AURION study, 100% (7/7) have achieved at least a 25% reduction in
proteinuria compared to study entry. A 25% reduction in proteinuria has
been shown to be predictive of a positive clinical response at 24 weeks.
All of the other pre-specified eight week biomarkers of active lupus
nephritis (LN) have also improved and are trending towards
normalization. These biomarkers have also been shown to be predictive of
positive clinical response rates at 24 weeks.
In the first eight weeks of a 48 week regimen of multi-target therapy
including voclosporin in AURION, an overall mean reduction of
proteinuria of 72% compared to pre-treatment levels was observed, and
57% (4/7) of these patients achieved complete remission as defined by a
urinary protein creatinine ratio of 0.5mg/mg. Overall renal function
as measured by eGFR in these patients has remained stable.
The AURION study is an open label, single arm, exploratory study
assessing the ability of biomarkers at 8 weeks to predict clinical
response rates at 24 and 48 weeks in subjects taking voclosporin 23.7mg
twice daily in combination with standard of care, mycophenolate mofetil
and corticosteroids, in patients with active LN. It is the first ever
trial with voclosporin in this patient population and supports the
Company's hypothesis that utilizing a multi-targeted approach with
voclosporin may help LN patients.
On March 2, 2016 the Company announced that the U.S. Food and Drug
Administration (FDA) granted Fast Track designation for voclosporin,
the Company's next generation calcineurin inhibitor, for the treatment
The Fast Track program was created by the FDA to facilitate the
development and expedite the review of new drugs that are intended to
treat serious or life-threatening conditions and that demonstrate the
potential to address significant unmet medical needs. Compounds that
receive this FDA designation benefit from more frequent meetings and
communications with the FDA to review the drug's development plan
including the design of clinical trials and the use of biomarkers to
support approval. Additionally, Fast Track designation allows the
Company to submit parts of the New Drug Application (NDA) on a rolling
basis for review as data becomes available. The Company expects to
analyse and review the AURA data with the FDA later in 2016 in order to
determine the appropriate next steps.
Looking forward - Expected upcoming milestone
Un-blinding and disclosure of the primary AURA trial data is scheduled
within approximately one month of the last enrolled patient completing
24 weeks of active treatment. Therefore, the Company expects that the
primary end-point results of the AURA trial will be released in the
third quarter ended September 30, 2016.
Financial results for the year ended December 31, 2015
The Company made significant progress with its ongoing AURA trial in
2015 with patient enrollment completed early in 2016. Activities focused
on the recruitment, enrollment and treatment of patients with lupus
nephritis (LN). Over 90 sites are set up in 20 countries worldwide. The
Company also made progress with its AURION study in Malaysia with eight
week data released on the first seven patients as noted above.
For the year ended December 31, 2015, the Company recorded a
consolidated net loss of $18.6 million or $0.58 per common share, as
compared to a consolidated net loss of $19.4 million or $0.67 per common
The change was primarily attributable to an increase of $6.9 million in
research and development costs offset by a change of $7.9 million in the
derivative warrant liability to a gain of $5.1 million for the year
ended December 31, 2015 compared to a loss of $2.8 million in 2014. In
addition the 2014 comparative figure reflected a gain on
extinguishment/re-measurement of warrant liability of $2.8 million.
There was no similar item 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, 2015 was $23.7 million compared to $16.6 million for
the corresponding period in 2014.
The Company incurred net research and development expenditures of $16.0
million for the year ended December 31, 2015, as compared to $9.1
million for the same period in 2014. Research and development