Mr. Richard Glickman reports
AURINIA ANNOUNCES ACCEPTANCE OF VOCLOSPORIN LATE-BREAKING PRESENTATION AT THE NATIONAL KIDNEY FOUNDATION 2017 SPRING CLINICAL MEETINGS
Aurinia Pharmaceuticals Inc.'s late-breaking
abstract for voclosporin has been accepted for oral presentation at the
National Kidney Foundation (NKF) 2017 Spring Clinical Meetings taking
place April 18 to April 22, 2017, in Orlando, Fla. The oral presentation, titled
"Treatment of Active Lupus Nephritis with Voclosporin: 48-Week Data from
the AURA-LV Study," will be made by lead author Dr. Samir Parikh, a
clinical investigator for the study and assistant professor, clinical
nephrology, at the Ohio State University, on Thursday, April 20, 2017,
from 4 p.m. ET to 5:30 p.m. ET.
A corresponding late-breaking poster presentation of the 48-week AURA-LV
study data will also be presented at the NKF 2017 Scientific Clinical
Meetings. A copy of the abstract will be available on the conference's
website.
"We're pleased that the AURA-LV 48-week data have been accepted for a
late-breaking oral presentation and look forward to sharing these
important results with the nephrology scientific and medical
communities," said Richard M. Glickman, Aurinia's chief executive
officer.
About AURA-LV
The AURA-LV study (Aurinia urinary
protein reduction in active lupus with voclosporin) is a 48-week study
comparing the efficacy of two doses of voclosporin added to current
standard of care of MMF (mycophenolate mofetil) against standard of care with placebo in
achieving complete remission in patients with active LN (lupus nephritis). All arms also received low
doses of corticosteroids as background therapy. Two hundred sixty-five patients were
enrolled at centres in 20 countries around the world. On entry to the study,
patients were required to have a diagnosis of LN according to
established diagnostic criteria (American College of Rheumatology) and
clinical and biopsy features indicative of highly active nephritis. The
24-week primary and secondary end points were released in the third quarter of 2016 where
the primary and all secondary end points were met. Complete remission is a composite
end point that includes: confirmed UPCR (urine-protein-to-creatinine ratio) of 0.5 milligram per milligram; normal, stable
renal function (equal to 60 millilitres per minute per 1.73 cubic metres or no confirmed decrease
from baseline in eGFR (estimated glomerular filtration rate) of 20 per cent); presence of sustained, low-dose steroids
(equal to 10-milligram prednisone from weeks 16 to 24); and no administration of rescue
medications. Partial remission in the trial is measured by a 50-per-cent reduction in UPCR
with no concomitant use of rescue medication.
About voclosporin
Voclosporin, an investigational
drug, is a novel and potentially best-in-class calcineurin inhibitor
(CNI) with clinical data in over 2,200 patients across indications.
Voclosporin is an immunosuppressant, with a synergistic and dual
mechanism of action that has the potential to improve near-term and
long-term outcomes in LN when added to standard of care (MMF). By
inhibiting calcineurin, voclosporin blocks IL-2 expression and T-cell
mediated immune responses. It is made by a modification of a single
amino acid of the cyclosporine molecule, which has shown a more
predictable pharmacokinetic and pharmacodynamic relationship, an
increase in potency, an altered metabolic profile, and potential for
flat dosing. The company 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.
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 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 have clinical LN requiring treatment. Unlike
SLE, LN has straightforward disease outcomes where an early response
correlates with long-term outcomes, measured by proteinuria. In patients
with LN, renal damage results in proteinuria and/or hematuria and a
decrease in renal function as evidenced by reduced 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 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.
We seek Safe Harbor.
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