Aurinia Highlights Renal Function Data from Global Phase IIb AURA Study of Voclosporin for Lupus Nephritis at American Societ...
November 21 2016 - 9:27AM
Business Wire
-AURA is the first global study of active lupus
nephritis to meet primary endpoint
-Renal function remains stable throughout
24-week treatment period
Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH / TSX:AUP) (“Aurinia”
or the “Company”), a clinical stage biopharmaceutical company
focused on the global immunology market, today announced highlights
from its global Phase IIb AURA study of voclosporin in the
treatment of lupus nephritis (LN) presented at the American Society
of Nephrology Kidney Week 2016 on November 19, 2016. The
late-breaking abstract presented in the “High Impact Clinical
Trials Session”, titled, “AURA-LV: Successful Treatment of Active
Lupus Nephritis with Voclosporin,” was presented by principal
investigator William Pendergraft, M.D., Ph.D., University of North
Carolina Kidney Center.
“There is a critical unmet need for an effective therapeutic
treatment of LN, a devastating and life-altering disease that, if
left untreated, can lead to end-stage renal disease and even
death,” said Dr. Pendergraft. “Until now, the LN clinical trial
landscape has been bleak, but AURA is now the first global study in
active LN to meet its primary endpoint and all pre-specified
secondary endpoints. Voclosporin 23.7mg BID doubled the odds of
patients reaching CR in the presence of very low corticosteroid
exposure, and maintained normal, stable renal function. Renal
function in active LN patients is often erratic, causing concern
for clinicians and patients. The observation that renal function in
voclosporin-treated patients remained stable throughout the study
period is extremely encouraging. Based on the favorable results of
the AURA study, I believe voclosporin will help patients who are
impacted by this disease.”
The AURA study enrolled 265 patients in 20 countries using low
dose (23.7 mg BID) voclosporin, high dose voclosporin (39.5 mg BID)
or placebo added to standard of care of mycophenolate mofetil (MMF)
and steroids in active LN. The study met its primary endpoint with
statistically significant CR rates in the 23.7mg BID arm, and
demonstrated statistically significant improvements across all
secondary endpoints: Partial Remission (PR); time to CR and PR;
reduction in Systemic Lupus Erythematosus Disease Activity Index
(SLEDA)I score; and reduction in UPCR over the 24-week treatment
period. In the voclosporin arms, the renal function as measured by
eGFR was stable and not significantly different from the control
arm during the course of the trial. Mean blood pressure was
slightly reduced and was similar between all treatment groups.
Adverse events occurred in both voclosporin groups (25.8% low,
25.0% high, 15.8% placebo) with the nature of adverse events
consistent with those observed in patients with highly active LN
and increased immunomodulation. The AURA study remains ongoing
until its 48-week secondary endpoints, which will be completed in
Q1 2017.
“The nephrology community’s positive reception to the AURA data
is encouraging as we prepare to initiate our single Phase III
clinical trial of voclosporin in Q2 2017,” said Neil Solomons,
M.D., Aurinia’s Chief Medical Officer. “We remain committed to
progressing this important therapy to market and believe it has the
potential to change the paradigm of care for patients living with
LN, significantly improving long-term outcomes and quality of
life.”
About VoclosporinVoclosporin, an investigational drug, is
a novel and potentially best-in-class calcineurin inhibitor (“CNI”)
with clinical data in over 2,000 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)Lupus Nephritis (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 AURORAThe AURORA study is a 52-week global
double-blind placebo controlled Phase III study that will compare
the efficacy of one dose of voclosporin (23.7mg BID) or placebo
added to current standard of care of mycophenolate mofetil (MMF,
also known as CellCept®) in achieving renal response (formerly
referred to as complete remission) in patients with active LN. Both
arms will also receive low doses of corticosteroids as part of
background therapy after a stringent taper. Aurinia believes this
Phase III clinical trial whose design is consistent with the
ongoing AURA study, will support a New Drug Application (NDA)
submission.
About AuriniaAurinia 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 lupus nephritis (LN). The company is headquartered
in Victoria, BC and focuses its development efforts globally.
www.auriniapharma.com.
Forward Looking StatementsThis press release contains
forward-looking statements, including statements related to
Aurinia's regulatory strategy, Aurinia's analysis, assessment and
conclusions of the results of the AURA-LV clinical study, and the
efficacy and commercial potential of voclosporin. 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.
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Investor & Media Contact:Aurinia Pharmaceuticals
Inc.Celia EconomidesHead of IR &
Communicationsceconomides@auriniapharma.com