Aurinia Doses First Patient in AURORA Phase 3 Clinical Trial of Voclosporin in Lupus Nephritis
May 17 2017 - 4:02PM
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 the first
patient has been dosed in AURORA, the Company’s Phase 3
confirmatory clinical trial evaluating voclosporin for the
treatment of lupus nephritis (LN), an autoimmune disease caused by
lupus that involves extreme inflammation and failure of the
kidneys.
“Dosing our first patient today is an important milestone for
the Company,” said Neil Solomons, M.D., Chief Medical Officer of
Aurinia. “Our Phase 3 trial design is nearly identical to that of
our successful Phase 2 AURA trial which demonstrated the potential
of voclosporin to increase both speed and rates of remission in
patients with active LN. We remain dedicated to advancing this
treatment and making a meaningful impact in the lives of patients
suffering from LN and those around them.”
AURORA is a 52-week global double-blind placebo controlled
study, designed to demonstrate that voclosporin added to the
current standard of care of mycophenolate mofetil (MMF) can
increase overall renal response rates in the presence of extremely
low steroids. The primary endpoint is complete renal response at 52
weeks. This trial will recruit ~320 patients and is intended to
support full marketing approval of voclosporin for patients with LN
across multiple regulatory jurisdictions.
“Lupus nephritis is a devastating disease which if not managed,
can be life-threatening. There is no approved medication to treat
the condition which mostly affects women in their childbearing
years,” said Mary Anne Dooley, M.D., M.P.H., Adjunct Professor of
Medicine at University of North Carolina School of Medicine and
principal investigator for the study. “The AURA Phase II results
showed great promise and if replicated in Phase 3, voclosporin has
the potential to change the current treatment paradigm for LN.”
About AURORAThe AURORA study is a 52-week global
double-blind placebo controlled Phase 3 study that will compare the
efficacy of one dose of voclosporin (23.7mg BID) to placebo when
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. For further questions
on the trial or interest in participating, please see our website
(http://www.auriniapharma.com/for-patients-physicians/clinical-trials)
or contact us at clinicaltrials@auriniapharma.com.
About VoclosporinVoclosporin, an investigational drug, is
a novel and potentially best-in-class calcineurin inhibitor (“CNI”)
with clinical trial 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. Voclosporin is made by a
modification of a single amino acid of the cyclosporine molecule
which results in a more predictable pharmacokinetic and
pharmacodynamic relationship with potential for flat dosing. In
addition, Voclosporin is more potent than and has an improved
metabolic profile versus cyclosporine. 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, an inflammation of the
kidney caused by Systemic Lupus Erythematosus (“SLE”), represents a
serious progression of SLE. SLE is a chronic, complex and often
disabling disorder that 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 a strong surrogate marker,
proteinuria, which correlates with meaningful longer term clinical
outcome. 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 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 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 ability to execute a successful Phase III program and
voclosporin potentially shifting the treatment paradigm for LN. 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, 2016 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20170517006240/en/
Aurinia Pharmaceuticals Inc.Investor Contact:Celia
EconomidesVP, Public Affairsceconomides@auriniapharma.comorMedia
Contact:Christopher Hippolyte,
212-364-0458Christopher.hippolyte@inventivhealth.com
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