Full Press Release Details
Reports Fourth Quarter and Full Year 2016 Financial Results and Recent
Operational Highlights
Phase IIb Study Meets 48-Week Remission Endpoints, Achieving Highest
Complete Remission Rate of Any Global Lupus Nephritis Study
AURA-LV Data to be presented in Late Breaker Presentation at National
Kidney Foundation 2017 Scientific Clinical Meetings
Phase III Trial with Voclosporin on Track to Commence Q2 2017
VICTORIA, British Columbia--(BUSINESS WIRE)--March 9, 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
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* | ||||||||||||||
| Complete Remission | 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 | |||||||||||||||
| Partial Remission | 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
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