Full Press Release Details
Announces Results from Japanese Phase I Ethnic Bridging Study for
support continued development of voclosporin in the Japanese patient
VICTORIA, British Columbia--(BUSINESS WIRE)--February 14, 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 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
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.
Voclosporin, 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.
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.
Forward Looking Statements
This 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.
Aurinia Pharmaceuticals Inc.
Head of IR & Communications
Hippolyte, 917-826-2664