Mr. Richard Glickman reports
AURINIA TO EXPAND RENAL FRANCHISE WITH NOVEL INDICATIONS AND LAUNCHES DEVELOPMENT PROGRAM FOR TREATMENT OF DRY EYE SYNDROME
Aurinia Pharmaceuticals Inc. plans to expand its voclosporin 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 per cent 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 enrolment 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, MD, 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 under way, 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, LLD, chief executive officer 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 finance all existing programs, the announced new programs, and operations into
2020.
Research and development day webcast
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, N.Y., and via webcast at the company's website.
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.
About DES
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.
About 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, and
affects more than 500,000 people in the United States (mostly women).
The disease is highly heterogeneous, affecting a wide range of organs and
tissue systems. It is estimated that as many as 60 per cent 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 voclosporin
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 with 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 VOS
VOS is an aqueous, preservative free nanomicellar
solution containing 0.2 per cent 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 Aurinia Pharmaceuticals Inc.
Aurinia 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, B.C., and focuses its
development efforts globally.
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