Aurinia Announces That Voclosporin Achieves Primary & All Pre-Specified Secondary Endpoints in Its Phase IIb AURA-LV Study fo...
September 29 2016 - 3:54PM
Business Wire
- AURA-LV is the first global active LN
study to meet its primary endpoint and all of its 24-week
pre-specified secondary endpoints
- Comprehensive mortality review
concludes that deaths in the AURA-LV study appear to be unrelated
to study drug and consistent with complications of LN
- Additional efficacy and safety analyses
from the AURA study will be presented and webcast live on Friday,
September 30th at 8:00am
Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) (“Aurinia”
or the “Company”) a clinical stage biopharmaceutical company
focused on the global immunology market, today announced that in
addition to voclosporin (23.7 mg BID) achieving its primary
endpoint of Complete Remission (CR) at 24 weeks, both doses of
voclosporin when added to the current standard of care of
Mycophenolate Mofetil (MMF) and a forced oral corticosteroid taper
have met all 24-week pre-specified secondary endpoints vs the
control group. These pre-specified endpoints include: Partial
Remission (PR), which is measured by a ≥50% reduction in UPCR with
no concomitant use of rescue medication; time to CR and PR;
reduction in Systemic Lupus Erythematosus Disease Activity Index or
SLEDAI score; and reduction in UPCR over the 24-week treatment
period.
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
All p-values are vs control
The AURA-LV study remains ongoing to its 48-week endpoint upon
which similar and additional secondary analysis will be analysed
and presented early next year.
“We are thrilled by the results of the AURA study and
voclosporin’s potential to shift the treatment paradigm for active
lupus nephritis,” said Charles Rowland, CEO of Aurinia. “The
ability to get more patients into remission and in a shorter period
time than the current standard of care can have a significant
impact on the long-term outcomes for these patients.”
“LN is a serious and devastating disease that can severely
impact a patient’s life,” said William Pendergraft, MD, PhD,
Assistant Professor of Medicine in the Division of Nephrology &
Hypertension, at the University of North Carolina and a Principal
Investigator in the study. “Voclosporin has demonstrated it can
nearly double the number of patients that achieve Complete
Remission in the presence of very low corticosteroid exposure.
Based on these data, I believe this drug has the potential to
significantly improve the long-term prognosis of my patients
afflicted with LN and could become an integral component of the
standard of care.”
The Company will present the full efficacy (including
pre-specified and ad hoc sub-analyses) and comprehensive safety
data during a webcast presentation to be held at 8:00am ET. A link
to the live webcast and slides will be available on the Investors
section of the Company’s website at
http://www.auriniapharma.com.
About AURA-LVThe AURA–LV study or “Aurinia Urine Protein
Reduction in Active Lupus Nephritis Study” compared the efficacy of
voclosporin added to current standard of care of mycophenolate
mofetil (MMF, also known as CellCept®) against standard of care
with placebo in achieving complete remission (CR) in patients with
active LN. Both arms also received low doses of corticosteroids as
background therapy. It enrolled 265 patients at centers in over 20
countries worldwide. On entry to the study, patients were required
to have a diagnosis of LN according to established diagnostic
criteria (American College of Rheumatology) and clinical and biopsy
features indicative of highly active nephritis.
About VoclosporinVoclosporin, an investigational drug, is
a novel and potentially best-in-class calcineurin inhibitor (“CNI”)
with clinical data in over 2,000 patients in other indications.
Voclosporin is an immunosuppressant, with a synergistic and dual
mechanism of action that has the potential to improve near- and
long-term outcomes in LN when added to standard of care (MMF). By
inhibiting calcineurin, voclosporin blocks IL-2 expression and
T-cell mediated immune responses. It is made by a modification of a
single amino acid of the cyclosporine molecule which has shown a
more predictable pharmacokinetic and pharmacodynamic relationship,
an increase in potency, an altered metabolic profile, and potential
for flat dosing. The Company anticipates that upon regulatory
approval, patent protection for voclosporin will be extended in the
United States and certain other major markets, including Europe and
Japan, until at least October 2027 under the Hatch-Waxman Act and
comparable laws in other countries.
About Lupus Nephritis (LN)Lupus Nephritis (LN) in an
inflammation of the kidney caused by Systemic Lupus Erythematosus
(SLE) and represents a serious progression of SLE. SLE is a
chronic, complex and often disabling disorder and affects more than
500,000 people in the United States (mostly women). The disease is
highly heterogeneous, affecting a wide range of organs & tissue
systems. It is estimated that as many as 60% of all SLE patients
have clinical LN requiring treatment. Unlike SLE, LN has
straightforward disease outcomes where an early response correlates
with long-term outcomes, measured by proteinuria. In patients with
LN, renal damage results in proteinuria and/or hematuria and a
decrease in renal function as evidenced by reduced estimated
glomerular filtration rate (eGFR), and increased serum creatinine
levels. LN is debilitating and costly and if poorly controlled, LN
can lead to permanent and irreversible tissue damage within the
kidney, resulting in end-stage renal disease (ESRD), thus making LN
a serious and potentially life-threatening condition.
About AuriniaAurinia is a clinical stage
biopharmaceutical company focused on developing and commercializing
therapies to treat targeted patient populations that are suffering
from serious diseases with a high unmet medical need. The company
is currently developing voclosporin, an investigational drug, for
the treatment of lupus nephritis (LN). The company is headquartered
in Victoria, BC and focuses its development efforts globally.
www.auriniapharma.com
Forward Looking StatementsThis press release contains
forward-looking statements, including statements related to
Aurinia's regulatory strategy (including plans to meet with the
U.S. Food and Drug Administration to discuss these data and the
voclosporin’s subsequent clinical development and path to
registration in LN), Aurinia's analysis, assessment and conclusions
of the results of the AURA-LV clinical study, and the efficacy and
commercial potential of voclosporin. It is possible that such
results or conclusions may change based on further analyses of
these data. Words such as "plans," "intends," “may,” "will,"
"believe," and similar expressions are intended to identify
forward-looking statements. These forward-looking statements are
based upon Aurinia’s current expectations. Forward-looking
statements involve risks and uncertainties. Aurinia’s actual
results and the timing of events could differ materially from those
anticipated in such forward-looking statements as a result of these
risks and uncertainties, which include, without limitation, the
risk that Aurinia’s analyses, assessment and conclusions of the
results of the AURA-LV clinical study set forth in this release may
change based on further analyses of such data, and the risk that
Aurinia’s clinical studies for voclosporin may not lead to
regulatory approval. These and other risk factors are discussed
under "Risk Factors" and elsewhere in Aurinia’s Annual Information
Form for the year ended December 31, 2015 filed with Canadian
securities authorities and available at www.sedar.com and on Form
40-F with the U.S. Securities Exchange Commission and available at
www.sec.gov, each as updated by subsequent filings, including
filings on Form 6-K. Aurinia expressly disclaims any obligation or
undertaking to release publicly any updates or revisions to any
forward-looking statements contained herein to reflect any change
in Aurinia's expectations with regard thereto or any change in
events, conditions or circumstances on which any such statements
are based.
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version on businesswire.com: http://www.businesswire.com/news/home/20160929006376/en/
AuriniaCelia EconomidesHead of IR &
Communicationsceconomides@auriniapharma.com