VICTORIA, British Columbia--(BUSINESS WIRE)--Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH / TSX:AUP) (“Aurinia” or the “Company”), a clinical stage biopharmaceutical company focused on the global immunology market, today announced that its late-breaking abstract for voclosporin has been accepted for oral presentation at the National Kidney Foundation (NKF) 2017 Spring Clinical Meetings taking place April 18-22, 2017 in Orlando, FL. 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 4:00 p.m. – 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 at: https://www.kidney.org/spring-clinical.
"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 against standard of care with placebo in
achieving CR in patients with active LN. All arms also received low
doses of corticosteroids as background therapy. 265 patients were
enrolled at centers in 20 countries worldwide. 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 endpoints were released in Q3 2016 where
the primary and all secondary endpoints were met. CR is a composite
endpoint that includes: confirmed UPCR of ≤0.5 mg/mg; normal, stable
renal function (≥60 mL/min/1.73m2 or no confirmed decrease
from baseline in eGFR of ≥20%); presence of sustained, low dose steroids
(≤10mg prednisone from week 16-24); and no administration of rescue
medications. PR in the trial is measured by a ≥50% 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- 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 & tissue systems. It is estimated that as many as
60% 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 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 Aurinia
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. The company is headquartered in Victoria, BC and
focuses its development efforts globally. www.auriniapharma.com
Forward Looking Statements
This press release
contains forward-looking statements, including statements related to
Aurinia’s ability to execute a successful Phase III program and
voclosporin potentially shifting the treatment paradigm for LN,
Aurinia's analysis, assessment and conclusions of the results of the
AURA-LV clinical study. It is possible that such results or conclusions
may change based on further analyses of these data. Words such as
"plans," "intends," “may,” "will," "believe," and similar expressions
are intended to identify forward-looking statements. These
forward-looking statements are based upon Aurinia’s current
expectations. Forward-looking statements involve risks and
uncertainties. Aurinia’s actual results and the timing of events could
differ materially from those anticipated in such forward-looking
statements as a result of these risks and uncertainties, which include,
without limitation, the risk that Aurinia’s analyses, assessment and
conclusions of the results of the AURA-LV clinical study set forth in
this release may change based on further analyses of such data, and the
risk that Aurinia’s clinical studies for voclosporin may not lead to
regulatory approval. These and other risk factors are discussed under
"Risk Factors" and elsewhere in Aurinia’s Annual Information Form for
the year ended December 31, 2015 filed with Canadian securities
authorities and available at www.sedar.com
and on Form 40-F with the U.S. Securities Exchange Commission and
available at www.sec.gov,
each as updated by subsequent filings, including filings on Form 6-K.
Aurinia expressly disclaims any obligation or undertaking to release
publicly any updates or revisions to any forward-looking statements
contained herein to reflect any change in Aurinia's expectations with
regard thereto or any change in events, conditions or circumstances on
which any such statements are based, except as required by law.
