Aurinia Announces Development Plans for Voclosporin in Europe and Japan
April 06 2017 - 4:12PM
Business Wire
- Single Phase III trial (AURORA) to serve as
basis for regulatory submissions in major markets—US, Europe, and
Japan
Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH / TSX:AUP) (“Aurinia”
or the “Company”), today announced the outcome of discussions with
both the European Medicines Agency (EMA) and the Pharmaceutical and
Medical Devices Agency (PMDA) in Japan regarding the development of
voclosporin for the treatment of active lupus nephritis (LN).
Pursuant to these discussions, the Company believes that the
confirmatory data that can be generated from the single Phase III
clinical trial (AURORA) and the recently completed AURA-LV (AURA)
Phase IIb study should support regulatory submissions in the US,
Europe and Japan.
“Our interactions with regulators in all three jurisdictions
have given us a clear pathway for Phase III, and we are confident
in our ability to execute AURORA successfully based on their
feedback and the information gleaned from the AURA study,” said
Lawrence D. Mandt, Vice President of Quality and Regulatory Affairs
at Aurinia. “The productive conclusion of these regulatory
interactions marks a milestone in our development program and
brings this exciting new therapeutic option one step closer to
those patients suffering from LN.”
The Phase III AURORA trial will be a global 52-week
double-blind, placebo controlled study of approximately 320
patients. Patients will be randomized 1:1: to either of 23.7mg
voclosporin BID and mycophenolate mofetil (MMF) or MMF and placebo,
with both arms receiving a stringent oral corticosteroid taper. As
in AURA, the study population will be comprised of patients with
biopsy-proven active LN who will be evaluated on the primary
efficacy endpoint of complete remission, or renal response, at 52
weeks, a composite which includes:
- Urinary/protein creatinine ratio (UPCR)
of ≤0.5mg/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)
- No administration of rescue
medications
“Based on the recent learnings from the positive AURA study at
48 weeks, we intend to use a UPCR of ≤0.5mg/mg and evaluate the
primary endpoint at 52 weeks in AURORA,” added Richard M. Glickman,
Aurinia’s Chief Executive Officer. “We are on track to initiating
the global AURORA study this quarter and fulfilling our goal of
improving the long-term outcomes for patients with this
disease.”
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.
About AURA-LVThe AURA–LV study (Aurinia Urinary Protein
Reduction in Active Lupus with Voclosporin) was 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 complete remission (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 with top-line 48-week
results announced in Q1 2017. The 48-week data has been accepted
for a late-breaking presentation at National Kidney Foundation
(NKF) Spring Clinical Meeting taking place April 18-22 in Orlando,
FL.
About VoclosporinVoclosporin, 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 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 around Aurinia's
global development and regulatory strategy, analysis, assessment
and conclusions around the future development 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 future development and commercial potential of voclosporin 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.
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Aurinia Pharmaceuticals Inc.Investor & Media
Contact:Celia EconomidesHead of IR &
Communicationsceconomides@auriniapharma.comorMedia:Christopher
Hippolyte, 212-364-0458Christopher.hippolyte@inventivhealth.com