Full Press Release Details
Initiates Clinical Trials Broadening the Development of Voclosporin
lupus nephritis patients roll over into AURORA 2 extension study
II FSGS Trial Initiated
VICTORIA, British Columbia--(BUSINESS WIRE)--June 25, 2018--Aurinia
Pharmaceuticals Inc. (NASDAQ:AUPH/TSX:AUP), a clinical stage
biopharmaceutical company focused on the global immunology market, today
announced the enrollment of the first patients into the AURORA 2
extension study in lupus nephritis and the initiation of its Phase II
trial in focal segmental glomerulosclerosis (FSGS).
The first patients have rolled over into the AURORA 2 extension study
from the AURORA Phase III clinical trial for lupus nephritis. The
purpose of AURORA 2 is to assess the long-term safety and tolerability
of voclosporin in patients with lupus nephritis; however, this study is
not a requirement for potential regulatory approval for voclosporin.
A Phase II open-label study of voclosporin has also been initiated for
the treatment of FSGS, a serious and potentially life-threatening kidney
disease, which is a leading cause of nephrotic syndrome. There are
currently no FDA or EMA approved therapies for FSGS. This Phase II,
multi-center study is designed to evaluate the safety and efficacy of
voclosporin as a first-line treatment for FSGS. The primary endpoint of
the study is the proportion of subjects achieving complete or partial
remission at 6 months.
This Phase II trial for FSGS adds a second renal indication to Aurinia's
active clinical development program for the oral formulation of
In addition, a third clinical program utilizing the Company's patented
topical namomicellar formulation of voclosporin, or VOS (voclosporin
ophthalmic solution) for the treatment of Dry Eye Syndrome (DES) is
scheduled to begin in the coming weeks. This head-to-head trial of
voclosporin vs. Restasis is a robust Phase IIa study with a four-week
primary endpoint of ocular tolerability.
"The AURORA Phase III clinical trial is progressing very well, and full
enrollment is anticipated to complete on time. Having the first lupus
nephritis patients complete AURORA and roll over into the AURORA 2
extension study reinforces our confidence in the program. This
achievement, coupled with initiating trials on new indications,
represents a significant milestone for the company," said Richard
Glickman, Aurinia's Chairman and Chief Executive Officer.
"Our clinical program for voclosporin has generated substantial data,
which serves as the basis for the pursuit of additional indications
where there is a high unmet medical need," said Neil Solomons, M.D.,
Aurinia's Chief Medical Officer. "We intend to complete the DES trial
before the end of 2018 and look forward to sharing ongoing data readouts
for FSGS over the course of 2019."
Aurinia Pharmaceuticals 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 potential treatment of lupus nephritis,
focal segmental glomerulosclerosis, and Dry Eye Syndrome. The company is
headquartered in Victoria, British Columbia and focuses its development
efforts globally. For further information, see our website at www.auriniapharma.com.
Voclosporin, an investigational drug, is a novel and potentially
best-in-class 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 (requires no
therapeutic drug monitoring), an increase in potency (vs cyclosporin),
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.
VOS (voclosporin ophthalmic solution) 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 I has also been completed in healthy
volunteers and patients with DES. VOS has IP protection until 2031.
About Lupus Nephritis (LN)
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. The disease is
highly heterogeneous, affecting a wide range of organs & 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
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.
FSGS is a rare disease that attacks the kidney's filtering units
(glomeruli) causing serious scarring which leads to permanent kidney
damage and even failure. FSGS is one of the leading causes of Nephrotic
Syndrome (NS) and is identified by biopsy and proteinuria. NS is a
collection of signs and 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
LN, early clinical response (measured by reduction of proteinuria) is
thought to be critical to long-term kidney health in patients with FSGS.
Currently, there are no approved therapies for FSGS in the United States
and the European Union.
About Dry Eye Syndrome (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