-Voclosporin 23.7mg BID to advance into
double-blind placebo controlled Phase III study
-AURORA Phase III study design consistent with
AURA
-Trial expected to commence in Q2 2017
-Conference Call and webcast at 8:30am ET
tomorrow
Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) (“Aurinia”
or the “Company”), today announced its plans for a single Phase III
clinical trial for voclosporin in the treatment of lupus nephritis
(LN). Pursuant to its recent End of Phase II meeting with the U.S.
Food & Drug Administration (FDA) Division of Pulmonary, Allergy
and Rheumatology Products, Aurinia believes this Phase III clinical
trial whose design is consistent with the ongoing AURA study, will
support a New Drug Application (NDA) submission.
“We are thrilled with the outcome and direction received from
the FDA. With a clear path forward for voclosporin’s development to
treat LN, we are mobilizing quickly to initiate the Phase III study
in Q2 next year, fulfilling our goal of improving the long-term
outcomes for patients with this disease,” added Charles Rowland,
Aurinia’s Chief Executive Officer.
The Phase III AURORA trial will be a global 52-week
double-blind, placebo controlled study of approximately 320
patients. The Company is finalizing the study protocol and
regulatory submissions and in parallel is working on site selection
with trial initiation anticipated in Q2 2017. Patients will be
randomized 1:1: to either of 23.7mg voclosporin BID and MMF or MMF
and placebo, with both arms receiving a stringent oral
corticosteroid taper. The study population will be comprised of
patients with biopsy-proven active LN who will be evaluated on the
primary efficacy endpoint of renal response at 24 weeks, a
composite which includes:
- Urinary/protein creatinine ratio (UPCR)
of ≤0.7mg/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
The readout of the primary endpoint of renal response at 24
weeks will occur after database lock at 52 weeks at which point the
Company intends to submit an NDA. Patients completing the 52-week
study will then have the option to roll-over into a 104 week
blinded continuation study. These data will allow the Company to
assess long-term outcomes in LN patients that will be valuable in a
post-marketing setting in addition to future interactions with
various regulatory authorities.
While voclosporin has received fast track designation, the FDA
has informed the Company that voclosporin is not eligible for
breakthrough therapy designation at this time. Aurinia will
continue to benefit from its fast track designation which includes
more frequent communications with the FDA and potential for
priority review and an option to submit a rolling NDA submission,
which may expedite the review process.
"We have shared a substantial amount of efficacy and safety data
with the FDA and are confident in our ability to execute a
successful Phase III clinical trial 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. “We
remain committed to addressing the unmet needs of patients living
with LN, a devastating disease, and look forward to making this
product available to patients as soon as possible.”
Conference Call and Webcast DetailsAurinia will host a
conference call and webcast tomorrow, November 3, 2016 at 8:30a.m.
Eastern Daylight Time to provide a clinical and regulatory update
on voclosporin. In order to participate in the conference call,
please dial +1-877-407-9170 (Toll-free US & Canada). An audio
webcast can be accessed under "Webcasts" through the “Investors”
section of the Aurinia corporate website at www.auriniapharma.com.
A replay of the webcast will be available on Aurinia’s website for
45 days.
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) 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 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 48-week results
to be announced in Q1 2017. The 24-week data have been accepted for
late-breaking presentations at the American College of Rheumatology
(ACR) and American Society of Nephrology (ASN).
About VoclosporinVoclosporin, an investigational drug, is
a novel and potentially best-in-class calcineurin inhibitor (“CNI”)
with clinical data in over 2,000 patients in other 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 measures 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, 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 lupus nephritis (LN). The company is headquartered
in Victoria, BC. Canada and focuses its development efforts
globally. www.auriniapharma.com.
Forward Looking StatementsThis press release contains
forward-looking statements, including statements around Aurinia's
analysis, assessment and conclusions around the future development
and commercial potential of voclosporin; the benefits of FDA fast
track designation and the timing of future clinical trials. 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, 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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Aurinia PharmaceuticalsCelia EconomidesHead of IR &
Communicationsceconomides@auriniapharma.com