Full Press Release Details
to Expand Renal Franchise with Novel Indications and Launches
Development Program for Treatment of Dry Eye Syndrome
to Initiate Clinical Trials for Treatment of FSGS, MCD, and Dry Eye in
2018 with Data Readouts in Second Half of 2018
Day Featuring KOLs in Nephrology and Ophthalmology Will be Webcast Today
at 8:30a.m. ET in New York
VICTORIA, British Columbia--(BUSINESS WIRE)--October 20, 2017--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
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
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
Aurinia believes its current financial resources are sufficient to fund
all existing programs, the announced new programs, and operations into
Members 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 NS
NS 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.
DES, 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.
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 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.
Voclosporin, 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