Full Press Release Details
Reports Fourth Quarter and Full Year 2018 Financial Results and
Operational Highlights
VICTORIA, British Columbia--(BUSINESS WIRE)--March 19, 2019--Aurinia
Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) ("Aurinia" or the
"Company") today reported its financial results for the fourth quarter
and year ended December 31, 2018. Amounts, unless specified otherwise,
are expressed in U.S. dollars.
2018 and Recent Highlights
Notice of Allowance from the United States Patent and Trademark
Office ("USPTO") for claims which have the potential to cover
voclosporin's method of use and dosing protocol for lupus nephritis
("LN') until December 2037.
Phase 2a Dry Eye Study results released in January 2019
demonstrating statistically superior efficacy of voclosporin
ophthalmic solution ("VOS") versus Restasis .
AURORA Phase 3 trial in LN completed patient enrollment, ahead of
schedule, in September 2018 - on track for top-line data in late 2019.
Phase 2 FSGS study with voclosporin initiated in June 2018 with
patient recruitment ongoing.
Cash, cash equivalents, and short-term investments of $125.9
million as of December 31, 2018.
Balance sheet strengthened with additional $30 million raised
through ATM facility during Q1 2019.
"The team at Aurinia has made extraordinary progress throughout 2018 by
achieving a number of significant clinical milestones with voclosporin,
and we are excited for what lies ahead in 2019. In addition to
completing enrollment in the AURORA Phase 3 trial ahead of schedule last
September, we also released Phase 2a dry eye study results with VOS that
we believe further demonstrate the potential of voclosporin", commented
Richard M. Glickman, Chief Executive Officer and Chairman of the Board
of Aurinia Pharmaceuticals."
Dr. Glickman further commented, "With the recent Notice of Allowance we
received from the USPTO for claims covering voclosporin's method of use
and dosing protocol for the treatment of proteinuric kidney diseases
including LN, we are very pleased with the additional exclusivity that
could extend to December 2037 which I believe provides additional value
creating opportunities for our shareholders.
USPTO Notice of Allowance
On February 25, 2019, Aurinia announced that it received a Notice of
Allowance from the USPTO for claims directed at its novel voclosporin
dosing protocol for LN (U.S. patent application 15/835,219, entitled
"PROTOCOL FOR TREATMENT OF LUPUS NEPHRITIS").
The allowed claims broadly cover the novel voclosporin individualized
flat-dosed pharmacodynamic treatment protocol adhered to and
required in both the previously reported Phase 2 AURA-LV trial and the
Company's ongoing Phase 3 confirmatory AURORA trial. Notably, the
allowed claims cover a method of modifying the dose of voclosporin in
patients with LN based on patient specific pharmacodynamic parameters.
This Notice of Allowance concludes a substantive examination of the
patent application at the USPTO, and after administrative processes are
completed and fees are paid, is expected to result in the issuance of a
U.S. patent with a term extending to December 2037. If the FDA approves
the use of voclosporin for LN and the label for such use follows the
dosing protocol under the Notice of Allowance, the issuance of this
patent will expand the scope of intellectual property protection for
voclosporin, which already includes robust manufacturing, formulation,
synthesis and composition of matter patents.
AURORA LN Clinical Trials
Aurinia's Phase 3 clinical trial ("AURORA") is evaluating voclosporin
for the treatment of LN, which was initiated in May of 2017, completed
enrollment in September 2018. The target enrolment of 324 patients was
surpassed due to high patient and investigator demand with 358 LN
patients randomized in sites across 27 countries. Top-line data is
expected to be available in Q4 2019.
A significant percentage of patients who have completed the AURORA trial
are rolling over into the AURORA blinded extension trial ("AURORA 2").
The purpose of AURORA 2 is to assess the long-term benefit/risk of
voclosporin in patients with LN; this trial is not a requirement for
potential regulatory approval of voclosporin.
Dry Eye Syndrome ("DES")
In July 2018, Aurinia initiated a Phase 2a head-to-head study of
voclosporin ophthalmic solution ("VOS") versus Restasis
(cyclosporine ophthalmic emulsion) 0.05% for the treatment of moderate
to severe DES. This four-week study enrolled a total of 100 patients.
In January 2019 the Company announced results from this study. The study
evaluated efficacy, safety and tolerability head to head with Restasis .
VOS showed statistical superiority to Restasis on FDA-accepted
objective signs of DES
42.9% of VOS subjects vs 18.4% of Restasis subjects (p=0.0055)
demonstrated 10mm improvement in Schirmer Tear Test ("STT") at Week 4
VOS showed statistical superiority to Restasis in Fluorescein
Corneal Staining ("FCS") (p=0.0003)
The primary endpoint of drop discomfort at 1-minute on the first
day of therapy showed no statistical difference between the treatment
groups, as both groups exhibited low drop discomfort scores
With respect to the primary endpoint of drop discomfort, VOS did not
meet the primary endpoint as both drugs were well tolerated and
demonstrated less than anticipated drop discomfort. However, secondary
outcome measures on efficacy, namely the STT and FCS, demonstrated
statistically superior results over Restasis .
Focal Segmental Glomerulosclerosis ("FSGS")
Aurinia initiated a Phase 2 proof-of-concept study for FSGS in June 2018
and is currently in the process of enrolling patients with this disease.
This proof-of-concept Phase 2 open-label study aims to enroll
approximately 20 treatment-na ve patients diagnosed with primary FSGS.
Financial Liquidity at December 31, 2018
At December 31, 2018, Aurinia had cash, cash equivalents and short-term
investments of $125.9 million compared to $173.5 million of cash and
short-term investments at December 31, 2017. Net cash used in operating
activities was $51.6 million for the year ended December 31, 2018,