- Voclosporin ophthalmic solution (VOS) results
on track to be reported in the fourth quarter of 2020 -
- Study builds on positive head-to-head data
with approved treatment reported in prior Phase 2a study -
- Dry eye syndrome is a chronic autoimmune
disorder affecting quality of life for millions in the U.S. -
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX:AUP) (Aurinia
or the Company), a late-stage clinical biopharmaceutical company
focused on advancing voclosporin across multiple autoimmune
conditions, today announced that the last patient study visit has
occurred in the Phase 2/3 AUDREY™ clinical study evaluating
voclosporin ophthalmic solution (VOS) for the potential treatment
of dry eye syndrome (DES).
“Despite the challenges posed by the ongoing viral pandemic, our
clinical operations team at Aurinia has maintained executional
excellence by completing the treatment phase of our major clinical
trial assessing VOS in this common chronic autoimmune disorder,
which affects more than 16 million people in the United States,”
said Peter Greenleaf, President and Chief Executive Officer of
Aurinia. “Based upon the striking efficacy results observed with
VOS in our head-to-head exploratory study against 0.05%
cyclosporine, we are excited to see the results of this clinical
trial which aims to fulfill a number of regulatory requirements
typically required by the FDA for this indication.”
The AUDREY Phase 2/3 DES study is evaluating VOS via a
randomized, double-masked, vehicle-controlled, dose ranging study
evaluating efficacy and safety in subjects with DES compared to
formulation. A total of 509 subjects were enrolled. The study
consists of four arms with a 1:1:1:1 randomization schedule,
patients received either 0.2% VOS, 0.1% VOS, 0.05% VOS or vehicle,
dosed twice daily for 12 weeks. The primary outcome measure for the
study is the proportion of subjects with a 10mm improvement in
Schirmer’s Tear Test (STT) at four weeks. Secondary outcome
measures include STT at 12 weeks and other time points, Fluorescein
Corneal Staining (FCS) at multiple time points, change in eye
dryness, burning/stinging, itching, photophobia, eye pain and
foreign body sensation at multiple time points, change in Symptom
Assessment in Dry Eye (SANDE) score at multiple time points, and
additional safety endpoints.
In January of 2019, Aurinia reported that although VOS
(voclosporin 0.2%) administered twice daily did not meet the
primary endpoint of drop discomfort at one-minute, it was superior
to Restasis® (0.05% cyclosporine A) administered twice daily in all
objective endpoints including FCS and STT. This statistical
superiority was seen as quickly as two weeks. Additionally,
voclosporin was given at four times the dose of cyclosporine with
no additional drop discomfort as measured by the drop discomfort
scores at one and five minutes after application. Based on these
data the Company has gained confidence that VOS represents a
potential best-in-class calcineurin inhibitor in ophthalmic
indications. This head-to-head study against the market leader was
the first study that has ever shown treatment superiority vs. an
active comparator in a double-blind randomized fashion.
Top-line results from the AUDREY clinical study are expected to
be reported during the fourth quarter of 2020.
About voclosporin ophthalmic solution (VOS)
VOS is an aqueous, preservative free nanomicellar solution
intended for use in the treatment of DES. Voclosporin is a
potentially best-in-class calcineurin inhibitor (CNI) that has been
shown to have a more predictable pharmacokinetic and
pharmacodynamic relationship, increase in potency (versus
cyclosporine) and an improved metabolic profile compared to legacy
CNIs. Calcineurin inhibition is a validated mechanism for the
treatment of ocular surface diseases. Positive Phase 2 results
demonstrated that VOS 0.2% administered twice daily was clinically
and statistically superior to 0.05% cyclosporine A (Restasis®)
administered twice daily across all objective endpoints over four
weeks.
About DES
Dry eye syndrome (DES) is characterized by irritation and
inflammation that occurs when the eye’s tear film is compromised by
reduced tear production, imbalanced tear composition, or excessive
tear evaporation. The impact of DES ranges from subtle, yet
constant eye irritation to significant inflammation and scarring of
the eye’s surface. Discomfort and pain resulting from DES can
reduce quality of life and cause difficulty reading, driving, using
computers and performing daily activities. DES is a chronic disease
estimated to affect more than 16 million people in the United
States. There are multiple FDA approved therapies for the treatment
of dry eye; however, there is opportunity for potential
improvements in the effectiveness, tolerability and onset of
action.
About Aurinia
Aurinia Pharmaceuticals is a
late-stage clinical 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 seeking FDA approval of voclosporin
for the potential treatment of lupus nephritis and evaluating
voclosporin ophthalmic solution (VOS) in a Phase 2/3 study for the
treatment of dry eye syndrome. The Company’s head office is in
Victoria, British Columbia, its U.S. commercial hub in Rockville,
Maryland, and focuses its development efforts globally.
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 regarding: expected timing of top-line
results from the AUDREY clinical trial during the fourth quarter of
2020; potential results from the AUDREY clinical trial replicating
the efficacy measures observed in the exploratory Phase 2 VOS study
in 2019; that DES is estimated to affect more than 16 million
people in the United States; and voclosporin and VOS being
potentially best-in-class CNIs; there is opportunity for potential
improvements in the effectiveness, tolerability and onset of action
in therapies to treat DES. 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: third party
service providers and patients completing matters relating to the
AUDREY clinical trial in a manner consistent with prior actions;
the size of the DES market; the results of Aurinia’s clinical
trials being accurate. Even though 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; clinical trial results may not
be accurate; we may not be able to reproduce the results of our
Phase 2 clinical study for VOS in our AUDREY Phase 2/3 clinical
trial; the size of the DES market in the United States may not be
as large as estimated. 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20200928005148/en/
Investor & Corporate Contact: Glenn Schulman, PharmD,
MPH Corporate Communications, Aurinia
gschulman@auriniapharma.com
Media Contact Stefan Riley Ten Bridge Communications
stefan@tenbridgecommunications.com
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