Aurinia Confirms Receipt of FDA End of Phase 2 Meeting Minutes
December 13 2016 - 7:00AM
Business Wire
-Minutes are consistent with previously issued
preliminary responses from FDA
-Single Phase 3 clinical trial to be conducted
with 23.7mg BID voclosporin for the treatment of active lupus
nephritis (LN)
-Trial on track to commence in Q2 2017
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 it
has received the final End of Phase II (EOP2) meeting minutes from
the U.S. Food & Drug Administration Division of Pulmonary,
Allergy and Rheumatology Products. The minutes are consistent with
the preliminary responses that were issued to the Company prior to
the meeting which took place on October 25, 2016.
As previously communicated, Aurinia will be conducting a single,
Phase 3 clinical trial assessing 23.7mg BID for the treatment of
active lupus nephritis (LN). The trial, which will be known as
AURORA, will be a global 52-week trial in approximately 320
patients. The primary endpoint as in the Phase 2b AURA trial is
renal response (complete remission), at 24 weeks. In addition to
the assessment of renal response, a key marker of clinical benefit
in this population is the duration of proteinuria improvement.
Therefore, secondary endpoints will include the duration of renal
response at 52 weeks (48 weeks in AURA), an efficacy measure which
delineates durability of renal response (remission), an important
parameter in evaluating long-term outcomes for the treatment of
LN.
Aurinia believes this Phase 3 clinical trial will support a New
Drug Application (NDA) submission.
“We have thoroughly reviewed the final EOP2 meeting minutes
provided to us by FDA, which are consistent with our previous
assessment and are moving as quickly as we can to initiate the
AURORA trial,” commented Lawrence D. Mandt, Vice President of
Quality and Regulatory Affairs at Aurinia.
“We are pleased to be working closely with FDA to bring this
treatment to market and helping as many people as possible
suffering from this debilitating disease,” added Charles Rowland,
Aurinia’s Chief Executive Officer. “Our clinical team has been
working on preparations for this important trial to meet our goal
of enrolling the first patient in Q2 2017. In the meantime, we
expect the AURA 48-week secondary endpoint durability of renal
response data in Q1 next year.”
About Voclosporin
Voclosporin, an investigational drug, is a novel and potentially
best-in-class calcineurin inhibitor (“CNI”) with clinical data in
over 2,000 patients across indications. The drug has received “Fast
Track Designation from the U.S. FDA. 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 AURORA
The 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 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 lupus
nephritis (LN). The company is headquartered in Victoria, BC and
focuses its development efforts globally.
www.auriniapharma.com.
We seek safe harbor.
Forward Looking Statements
This press release contains forward-looking statements,
including statements related to Aurinia's regulatory strategy, and
projections regarding the Phase III AURORA clinical trial 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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20161213005650/en/
Investors & Media:Aurinia Pharmaceuticals Inc.Celia
EconomidesHead of IR &
Communicationsceconomides@auriniapharma.com