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Aurinia Reports Third Quarter 2016 Financial Results and Operational Highlights AURA first global clinical trial in lupus nephritis that meets primary and all secondary endpoints AURION 24-week results support the use of

Key Takeaway: Reports Third Quarter 2016 Financial Results and Operational Highlights first global clinical trial in lupus nephritis that meets primary and all secondary endpoints 24-week results support the use of voclosporin for the treatment of completion of EOP2 meeting with FDA VICTO

Full Press Release Details

Reports Third Quarter 2016 Financial Results and Operational Highlights
first global clinical trial in lupus nephritis that meets primary and
all secondary endpoints
24-week results support the use of voclosporin for the treatment of
completion of EOP2 meeting with FDA
VICTORIA, British Columbia--(BUSINESS WIRE)--November 4, 2016--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.
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
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 by UPCR 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
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
Last updated: Nov 4, 2016