Aurinia Announces Results from Japanese Phase I Ethnic Bridging Study for Voclosporin
February 14 2017 - 7:00AM
Business Wire
Data support continued development of
voclosporin in the Japanese patient population
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP)
(“Aurinia” or the “Company”), a clinical stage biopharmaceutical
company focused on the global immunology market, today announced
the results of a supportive Phase I safety, pharmacokinetic (PK)
and pharmacodynamic (PD) study in healthy Japanese patients which
supports further development of voclosporin in this patient
population.
Based on evaluations comparing the Japanese ethno-bridging data
vs. previous PK and PD studies in non-Japanese patients,
voclosporin demonstrated no statistically significant differences
in exposure with respect to Area Under the Curve (AUC)
measurements. Furthermore, the PK parameters in Japanese patients
were generally consistent with previously evaluated PK parameters
in non-Japanese volunteers. There were no unusual or unexpected
safety signals in the study.
“We are encouraged by these results as they appear to support
our hypothesis that the PK and PD of voclosporin is similar among
ethnic groups,” said Lawrence Mandt, VP of Regulatory and Quality
of Aurinia. “Additionally, the data support the use of the 23.7mg
BID voclosporin dose in our global Phase 3 study in both Japanese
and non-Japanese patients. We look forward to sharing our findings
with the Japanese Pharmaceuticals and Medical Devices Agency
(“PMDA”) in Q2 and confirming our path forward for regulatory
submission in Japan.”
“Japan represents an important market opportunity for
voclosporin to treat patients with active lupus nephritis” said
Richard Glickman, CEO of Aurinia. “The results of this study will
support our upcoming discussions with Japanese regulatory
authorities and potential partners as we continue our efforts to
bring this important therapy to patients around the globe.”
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 VoclosporinVoclosporin, an investigational drug, is
a novel, best-in-class calcineurin inhibitor (“CNI”) with clinical
data in over 2,000 patients across multiple 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. The Company anticipates that upon
regulatory approval, patent protection for voclosporin will be
extended in the United States to at least late 2027 under the
Hatch-Waxman Act.
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 clinical and regulatory strategy, and future clinical
development plans for voclosporin, including the initiation of its
planned pivotal Phase 3 trial in the second quarter of 2017,
analysis, assessment and conclusions of the results of clinical
studies of voclosporin, including the Phase 1 study conducted in
Japan. 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
voclosporin clinical studies 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:Aurinia Pharmaceuticals Inc.Celia EconomidesHead
of IR &
Communicationsceconomides@auriniapharma.comorMedia:Christopher
Hippolyte, 917-826-2664Christopher.hippolyte@inventivhealth.com