- Data to be shared as a late-breaking oral
presentation during the live virtual NKF conference -
Aurinia Pharmaceuticals Inc.
(NASDAQ:AUPH) (TSX:AUP) (“Aurinia” or the “Company”), a late-stage
clinical biopharmaceutical company focused on advancing voclosporin
in multiple indications, today announced that clinical data from
its AURORA Phase 3 trial will be highlighted in a late-breaking
oral presentation during the National Kidney Foundation (“NKF”)
2020 Spring Clinical Meetings, which will be held as a live-virtual
meeting per recommendations by the Centers for Disease Control and
Prevention (“CDC”). The AURORA pivotal trial evaluated voclosporin
in combination with mycophenolate (“MMF”) and low-dose
corticosteroids for the treatment of lupus nephritis (“LN”).
Aurinia previously announced
positive efficacy and safety results from the AURORA Phase 3
pivotal trial in December 2019. These data will be submitted as
part of the rolling submission for the voclosporin new drug
application (“NDA”), which the Company expects to complete by the
end of the second quarter of 2020.
Full
Presentation Details
Title: Aurora Phase 3 Trial
Demonstrates Voclosporin Statistical Superiority Over Standard of
Care in Lupus Nephritis (LN) Session: Late-Breaking Abstract
Presentations Presenter: Keisha Gibson, M.D., Ph.D.,
University of North Carolina School of Medicine, Chapel Hill, NC
Date: Thursday, March 26, 2020; 4:15 p.m. – 4:45 p.m. CT
Following the session, a reprint of
the slide presentation will be accessible from Aurinia’s website
at: https://ir.auriniapharma.com/presentations.
About AURORA
The AURORA Phase 3 clinical trial is
a global, double-blind, placebo-controlled study to evaluate
whether voclosporin when added to background therapy of
mycophenolate mofetil (MMF)/CellCept® can increase speed of and
overall renal response rates in the presence of low dose steroids.
The primary endpoint for the study is complete renal response at 52
weeks, after which patients can choose to enroll into a 104-week
blinded extension study. Renal response was defined as UCPR of ≤
0.5 mg/mg, eGFR ≥ 60 mL/min/1.73 m2, or no confirmed decrease from
baseline in eGFR of > 20%, presence of sustained, low dose
steroids and no administration of rescue medication. The target
enrollment of 324 patients was surpassed with a total of 357 lupus
nephritis (LN) patients randomized globally across sites in 27
countries.
About Voclosporin
Voclosporin, an investigational
drug, is a novel and potentially best-in-class calcineurin
inhibitor (“CNI”) with clinical data in over 2,600 patients across
indications. Voclosporin is an immunosuppressant, with a
synergistic and dual mechanism of action. By inhibiting
calcineurin, voclosporin blocks IL-2 expression and T-cell mediated
immune responses and stabilizes the podocyte in the kidney. It has
been shown to have a more predictable pharmacokinetic and
pharmacodynamic relationship (potentially requires no therapeutic
drug monitoring), an increase in potency (versus cyclosporine A),
and an improved metabolic profile compared to legacy CNIs. Aurinia
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 and until April 2028 with anticipated pediatric
extension. Further, a U.S. patent has also been issued covering the
voclosporin dosing protocol with a term extending to December 2037,
if the FDA incorporates the dosing protocol used in both the AURA
and AURORA trials into the product label.
About Lupus Nephritis
Lupus nephritis (“LN”) is 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. The disease is
highly heterogeneous, affecting a wide range of organs and tissue
systems. Unlike SLE, LN has straightforward disease outcomes
(measuring proteinuria) where an early response correlates with
long-term outcomes. In patients with LN, renal damage results in
proteinuria and/or hematuria and a decrease in renal function as
evidenced by reduced 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 Aurinia
Aurinia Pharmaceuticals is a late
clinical-stage biopharmaceutical company focused on developing and
commercializing therapies to treat targeted patient populations
that are impacted by serious diseases with a high unmet medical
need. The Company is currently developing an investigational drug,
for the treatment of lupus nephritis, focal segmental
glomerulosclerosis and dry eye syndrome. The Company’s head office
is in Victoria, British Columbia and focuses its development
efforts globally. For further information, see our website at
www.auriniapharma.com.
Forward-Looking
Statements
Certain statements made in this
press release may constitute forward-looking information within the
meaning of applicable Canadian securities law and forward-looking
statements within the meaning of applicable United States
securities law. These forward-looking statements or information
include but are not limited to statements or information with
respect to: positive efficacy and safety results from the AURORA
Phase 3 pivotal trial, completing NDA priority review submissions
in a successful and timely manner including a rolling submission
and the anticipated NDA filing during the first half of 2020; the
potential for commercial launch of voclosporin for use in LN in
2021; timeline challenges due to the COVID-19 outbreak, voclosporin
being potentially a best-in-class CNI with robust intellectual
property exclusivity; Aurinia’s anticipation that upon regulatory
approval, patent protection for voclosporin composition of matter
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
and until April 2028 with anticipated pediatric extension; a US
patent has also been issued covering the voclosporin dosing
protocol with a term extending to December 2037, if the FDA
incorporates the dosing protocol used in both the AURA and the
AURORA studies into the product label; that the results of the
AURORA clinical study are pivotal and a potential game changer for
LN patients; that voclosporin may be positioned to become the
standard of care for people living with LN; that Aurinia will
present AURORA study results at a future scientific conference
during 2020. It is possible that such results or conclusions may
change based on further analyses of these data. Words such as
“anticipate”, “will”, “believe”, “estimate”, “expect”, “intend”,
“target”, “plan”, “goals”, “objectives”, “may” and other similar
words and expressions, identify forward-looking statements. We have
made numerous assumptions about the forward-looking statements and
information contained herein, including among other things,
assumptions about: the market value for the LN, DES and FSGS
programs; that another company will not create a substantial
competitive product for Aurinia’s LN, DES and FSGS business without
violating Aurinia’s intellectual property rights; the burn rate of
Aurinia’s cash for operations; the costs and expenses associated
with Aurinia’s clinical trials; the planned studies achieving
positive results; Aurinia being able to extend and protect its
patents on terms acceptable to Aurinia; and the size of the LN, DES
or FSGS markets; Aurinia will be able to obtain all necessary
regulatory approvals for commercialization of voclosporin for use
in LN on terms that are acceptable to it and that are commercially
viable; and that Aurinia’s intellectual property rights are valid
and do not infringe the intellectual property rights of other
parties. Even though the management of Aurinia believes that the
assumptions made, and the expectations represented by such
statements or information are reasonable, there can be no assurance
that the forward-looking information will prove to be accurate.
Forward-looking information by their
nature are based on assumptions and involve known and unknown
risks, uncertainties and other factors which may cause the actual
results, performance or achievements of Aurinia to be materially
different from any future results, performance or achievements
expressed or implied by such forward-looking information. Should
one or more of these risks and uncertainties materialize, or should
underlying assumptions prove incorrect, actual results may vary
materially from those described in forward-looking statements or
information. Such risks, uncertainties and other factors include,
among others, the following: difficulties, delays, or failures we
may experience in the conduct of our clinical trial; difficulties
we may experience in completing the development and
commercialization of voclosporin; the market for the LN, DES and
FSGS business may not be as estimated; Aurinia may have to pay
unanticipated expenses; estimated costs for clinical trials may be
underestimated, resulting in Aurinia having to make additional
expenditures to achieve its current goals; Aurinia not being able
to extend or fully protect its patent portfolio for voclosporin;
competitors may arise with similar products; Aurinia may not be
able to obtain necessary regulatory approvals for commercialization
of voclosporin in a timely fashion, or at all; and Aurinia may not
be able to obtain sufficient supply to meet commercial demand for
voclosporin in a timely fashion. Although we have attempted to
identify factors that would cause actual actions, events or results
to differ materially from those described in forward-looking
statements and information, there may be other factors that cause
actual results, performances, achievements or events to not be as
anticipated, estimated or intended. Also, many of the factors are
beyond our control. There can be no assurance that forward-looking
statements or information will prove to be accurate, as actual
results and future events could differ materially from those
anticipated in such statements. Accordingly, you should not place
undue reliance on forward-looking statements or information.
Except as required by law, Aurinia
will not update forward-looking information. All forward-looking
information contained in this press release is qualified by this
cautionary statement. Additional information related to Aurinia,
including a detailed list of the risks and uncertainties affecting
Aurinia and its business can be found in Aurinia’s most recent
Annual Information Form available by accessing the Canadian
Securities Administrators’ System for Electronic Document Analysis
and Retrieval (SEDAR) website at www.sedar.com or the U.S.
Securities and Exchange Commission’s Electronic Document Gathering
and Retrieval System (EDGAR) website at www.sec.gov/edgar.
We seek safe harbour.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200318005132/en/
Investor & Corporate Contact: Glenn Schulman, PharmD,
MPH Corporate Communications, Aurinia
gschulman@auriniapharma.com
Media Contact Krystle Gibbs Ten Bridge Communications
krystle@tenbridgecommunications.com
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