Company to Initiate Clinical Trials for
Treatment of FSGS, MCD, and Dry Eye in 2018 with Data Readouts in
Second Half of 2018
R&D Day Featuring KOLs in Nephrology and
Ophthalmology Will be Webcast Today at 8:30a.m. ET in New
York
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (Aurinia)
today announced plans to expand its voclosoprin renal franchise to
include focal segmental glomerulosclerosis (FSGS) and minimal
change disease (MCD). Additionally, Aurinia announced plans to
evaluate its proprietary nanomicellar voclosporin ophthalmic
solution (VOS) for the treatment of keratoconjunctivitis sicca or
dry eye syndrome (DES). The advancement of these new indications,
in addition to lupus nephritis (LN), represents an expansion of the
company’s strategy, pipeline and commercial opportunities.
A Phase II proof of concept clinical trial for voclosporin in
FSGS and MCD patients will be initiated in the first half of 2018.
FSGS and MCD affect nearly 150,000 patients globally, accounting
for almost 50% of patients with Nephrotic Syndrome (NS). The
prevalence of FSGS and MCD is increasing through improved
diagnosis, and it has been shown that the control of proteinuria is
important for long-term survival of these patients. Interim data
readouts are anticipated in the second half of 2018.
Aurinia also plans to begin a Phase IIa tolerability study of
VOS versus the standard of care for the treatment of DES by the
second quarter of 2018, with data available in the second half of
2018. Calcineurin inhibitors are a mainstay in the treatment for
DES, and the goal of this program is to develop a best-in-class
treatment option.
Aurinia’s Phase III clinical study (AURORA) for the treatment of
LN is on track to complete enrollment in the second half of 2018,
with 113 clinical trial sites active around the globe.
Additionally, under voclosporin’s fast-track designation, Aurinia
intends to utilize a rolling New Drug Application (NDA) process,
with the first module being submitted in the second half of
2018.
“Our clinical data in LN demonstrated that voclosporin
profoundly decreased proteinuria, which is also an important
disease marker for FSGS and MCD. Furthermore, voclosporin appears
to demonstrate a more predictable pharmacology and an improved
lipid and metabolic profile over legacy calcineurin inhibitors,
which have shown efficacy in treating autoimmune disorders similar
to those we are targeting,” said Neil Solomons, M.D., Chief Medical
Officer of Aurinia Pharmaceuticals. “The topical formulation, VOS,
has shown evidence of efficacy in our partnered canine studies and
in a human Phase I study, supporting its development in DES.”
“With the AURORA trial in LN now well underway, we’re poised to
enter the next phase of development for Aurinia. By leveraging our
expertise and the unique profile of voclosporin to pursue these
novel indications, we hope to bring new treatment options to
patients where significant unmet medical need remains,” said
Richard Glickman, L.L.D., CEO and Chairman of Aurinia
Pharmaceuticals. “Furthermore, we believe our pipeline expansion
has the potential to create significant value for
shareholders.”
Aurinia believes its current financial resources are sufficient
to fund all existing programs, the announced new programs, and
operations into 2020.
R&D Day webcastMembers of the Aurinia leadership team
and external key opinion leaders will provide insights for
voclosporin in LN and the new indications at an R&D Day, being
held today at 8:30 a.m. Eastern Time in New York, NY and via
webcast at http://ir.auriniapharma.com/ir-calendar.
About FSGS, MCD and NSNS is a collection of symptoms that
indicate kidney damage, including: large amounts of protein in
urine; low levels of albumin and higher than normal fat and
cholesterol levels in the blood, and edema. Similar to lupus
nephritis, early clinical response and reduction of proteinuria is
thought to be critical to long-term kidney health. Aurinia is
focused specifically on FSGS, a lesion characterized by persistent
scarring identified by biopsy and proteinuria and on MCD, a kidney
disease in which large amounts of protein are lost in the urine.
FSGS and MCD both are causes of NS and characterized by high
morbidity. Currently, there are no approved therapies for FSGS and
MCD in the United States and the European Union.
About DESDES, or keratoconjunctivitis sicca, is a chronic
disease in which a lack of moisture and lubrication on the eye’s
surface results in irritation and inflammation of the eye. DES is a
multifactorial, heterogeneous disease estimated to affect greater
than 20 million people in the United States.
About LNLN 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 percent of all SLE patients will develop clinical LN
requiring treatment. 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 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 VoclosporinVoclosporin, an investigational drug, is
a novel and potentially best-in-class calcineurin inhibitor (CNI)
with clinical data in over 2,400 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,
an increase in potency, an altered metabolic profile and potential
for flat dosing 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.
About VOSVOS is an aqueous, preservative free
nanomicellar solution containing 0.2% voclosporin intended for use
in the treatment of DES. Studies have been completed in rabbit and
dog models, and a single Phase 1 has also been completed in healthy
volunteers and patients with DES. VOS has IP protection until 2031.
In April 2017, Aurinia announced an agreement granting Merck Animal
Health (MAH) worldwide rights to develop and commercialize (VOS)
for the treatment of DES in dogs. MAH previously conducted proof of
concept research in dogs suffering from DES, which affects one out
of every 22 dogs.
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 LN, FSGS, MCD and DES. The company is
headquartered in Victoria, BC and focuses its development efforts
globally. For further information, see our website at
www.auriniapharma.com.
Forward Looking Information Disclaimer
Certain of the 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:
voclosporin being potentially a best-in-class CNI with robust
intellectual property exclusivity; the timing for Aurinia
initiating a Phase II clinical trial for voclosporin in FSGS and
MCD patients; the timing for interim data readouts for the Phase II
clinical trial for FSGS and MCD patients; the timing for
commencement of a Phase IIa tolerability study of VOS; the timing
for data availability for the Phase IIa tolerability study; the
anticipated commercial potential of voclosporin for the treatment
of LN, NS, FSGS, DES and other autoimmune diseases; that the
expansion of the renal franchise could create significant value for
shareholders; that Aurinia’s current financial resources are
sufficient to fund all existing programs, the announced new
programs and operations into 2020;. When used in these marketing
materials, the words “anticipate”, “will”, “believe”, “estimate”,
“expect”, “intend”, “target”, “plan”, “goals”, “objectives”, “may”
and other similar words and expressions, identify forward-looking
statements or information.
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 program;
that another company will not create a substantial competitive
product for Aurinia’s LN 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 its patents on terms acceptable to
Aurinia; and the size of the LN market. 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: the market for the LN 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 its patent portfolio for
voclosporin; and competitors may arise with similar products.
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.
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Aurinia Pharmaceuticals Inc.Investors:Celia
EconomidesVP, Corporate & Public
Affairsceconomides@auriniapharma.comorMedia:Christopher
Hippolyte, 212-364-0458Christopher.hippolyte@inventivhealth.com