Full Press Release Details
Reports First Quarter 2017 Financial Results, Announces Initiation of
Phase III Aurora Clinical Trial, and Provides Operational Highlights
Phase III Trial with Voclosporin Has Been Initiated
$202.1 million as of March 31, 2017, Providing Resources to Fund Company
Phase IIb Trial Met Key 48-Week Endpoints, Achieving Highest Complete
Remission Rate of Any Global Lupus Nephritis Study
$9.7 million used for operating activities in Q1 2017
VICTORIA, British Columbia--(BUSINESS WIRE)--May 15, 2017--Aurinia
Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) ("Aurinia" or the
"Company") has released its financial results for the first quarter
ended March 31, 2017. Amounts, unless specified otherwise, are expressed
"I am proud of the important clinical, regulatory and financial
milestones our team has successfully achieved in our first quarter this
year. We released positive 48-week results from our Phase IIb AURA-LV
("AURA") trial of voclosporin, which demonstrated significantly improved
complete remission rates in patients suffering from lupus nephritis,"
said Richard Glickman, Aurinia's CEO and Chairman of the Board. "We also
believe we have a clear path forward with regulators to develop
voclosporin in major markets and have successfully funded the Company's
initiated Phase III lupus nephritis clinical trial ("AURORA") and
operations through 2020. Furthermore, based on the results of our AURA
trial and regulatory feedback, we have moved diligently into our AURORA
trial with several sites initiated and currently screening patients. Our
clinical team is focused on continuing to initiate sites with an
aggressive patient recruitment program. The AURORA trial design is
consistent with that of the recently completed AURA clinical trial. We
believe that the totality of data from both the AURORA and AURA trials
will ultimately serve as the basis for a New Drug Application ("NDA")
submission as well as regulatory submissions in other major global
Recent operational highlights
48-Week AURA-LV Data presented in Late Breaker Presentation at
National Kidney Foundation 2017 Scientific Clinical Meeting
On April 20, 2017 we announced additional 48-week results from the
global AURA study in lupus nephritis ("LN") during the National Kidney
Foundation 2017 Spring Clinical Meetings in Orlando, FL. In addition to
the trial meeting its complete and partial remission ("CR"/"PR")
endpoints at 48 weeks, all pre-specified secondary endpoints that have
been analyzed to date were also met at 48 weeks. These pre-specified
endpoints include: time to CR and PR (speed of remission); reduction in
Systemic Lupus Erythematosus Disease Activity Index or SLEDAI score; and
reduction in urine protein creatinine ratio ("UPCR") over the 48-week
treatment period. Notably, of the patients that achieved CR at 24 weeks,
in the low-dose voclosporin group, 100% remained in CR at 48 weeks,
which demonstrates durability of clinical response. Proteinuria levels
and reduction in SLEDAI scores, which include non-renal measures of
lupus activity, also continued to significantly separate over time
versus the control group. Additional analyses are ongoing and will be
presented at future medical and scientific meetings.
No unexpected safety signals were observed and voclosporin was generally
well-tolerated, with the nature of adverse events consistent with what
is expected of patients suffering from highly active LN while undergoing
immunomodulation therapy. In the voclosporin arms, the renal function as
measured by eGFR was stable and not significantly different from the
control arm during the 48-week treatment period. Mean blood pressure was
also similar between all treatment groups.
The 24 and 48-week efficacy results are summarized below:
| Endpoint | Treatment | 24 weeks | P-value* | 48 weeks | P-value* | |||||||||||||||
| Complete Remission (CR) | 23.7mg VCS BID | 33% | p=.045 | 49% | p<.001 | |||||||||||||||
| 39.5mg VCS BID | 27% | p=.204 | 40% | p=.026 | ||||||||||||||||
| Control Arm | 19% | NA | 24% | NA | ||||||||||||||||
| Partial Remission (PR) | 23.7mg VCS BID | 70% | p=.007 | 68% | p=.007 | |||||||||||||||
| 39.5mg VCS BID | 66% | p=.024 | 72% | p=.002 | ||||||||||||||||
| Control Arm | 49% | NA | 48% | NA | ||||||||||||||||
| Time to CR (TTCR) [median] | 23.7mg VCS BID | 19.7 weeks | p<.001 | 19.7 weeks | p<.001 | |||||||||||||||
| 39.5mg VCS BID | 23.4 weeks | p=.001 | 23.4 weeks | p<.001 | ||||||||||||||||
| Control Arm | NA | NA | NA | NA | ||||||||||||||||
| Time to PR (TTPR) [median] | 23.7mg VCS BID | 4.1 weeks | p=.002 | 4.3 weeks | p=.005 | |||||||||||||||
| 39.5mg VCS BID | 4.4 weeks | P=.003 | 4.4 weeks | p=.002 | ||||||||||||||||
| Control Arm | 6.6 weeks | NA | 6.6 weeks | NA | ||||||||||||||||
| SLEDAI Reduction (non-renal lupus) | 23.7mg VCS BID | -6.3 | p=.003 | -7.9 | p<.001 | |||||||||||||||
| 39.5mg VCS BID | -7.1 | p=.003 | -8.3 | p<.001 | ||||||||||||||||
| Control Arm | -4.5 | NA | -5.3 | NA | ||||||||||||||||
| Reduction in UPCR | 23.7mg VCS BID | -3.769 mg/mg | p<.001 | -3.998 mg/mg | p<.001 | |||||||||||||||
| 39.5mg VCS BID | -2.792 mg/mg | p=.006 | -2.993 mg/mg | p=.008 | ||||||||||||||||
| Control Arm | -2.216 mg/mg | NA | -2.384 mg/mg | NA | ||||||||||||||||
| Note: "VCS" means voclosporin | *All p-values are vs control |
Regulatory pathway forward
On April 7, 2017 we announced the outcome of discussions with both the
European Medicines Agency (EMA) and the Pharmaceutical and Medical
Devices Agency (PMDA) in Japan regarding the development of voclosporin
for the treatment of active LN. Pursuant to these discussions, we
believe that the confirmatory data that can be generated from the AURORA
trial and the recently completed AURA trial should support regulatory
submissions in the US, Europe and Japan.
The AURORA trial will be a global 52-week double-blind, placebo
controlled study of approximately 320 patients. Patients will be
randomized 1:1: to either of 23.7mg voclosporin BID and mycophenolate
mofetil (MMF) or MMF and placebo, with both arms receiving a stringent
oral corticosteroid taper. As in AURA, the study population will be
comprised of patients with biopsy-proven active LN who will be evaluated
on the primary efficacy endpoint of complete remission, or renal
response, at 52 weeks, a composite which includes:
Normal, stable renal function ( 60 mL/min/1.73m2 or
no confirmed decrease from baseline in eGFR of >20%)
Presence of sustained, low dose steroids ( 10mg prednisone from week
No administration of rescue medications throughout the treatment period
Key Developments in First Quarter, 2017
Completion of Public Offering
On March 20, 2017 we announced the closing of an underwritten
public offering of 25.64 million common shares. The shares were sold at
a public offering price of $6.75 per share. The gross offering proceeds
to the Company from this Offering were US$173.1 million. Expenses of the
offering including underwriting commissions and other offering expenses
AURA 48-Week Results
On March 1, 2017, we announced top-line results from the AURA trial. At
48 weeks, the trial met the 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. 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
Japanese Phase I Ethnic Bridging Study for Voclosporin
On February 14, 2017, we 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