- Integrated analysis confirms statistically
superior efficacy and safety of voclosporin in combination with MMF
and steroids over standard-of-care –
- Voclosporin pharmacokinetic data supports
consistent dose-response, potentially eliminating the need for
therapeutic drug monitoring –
Aurinia Pharmaceuticals Inc. (Nasdaq:AUPH / TSX:AUP) (“Aurinia”
or the “Company”), a late-stage clinical biopharmaceutical company
focused on advancing voclosporin across multiple indications, today
announced that integrated efficacy and pharmacokinetic (PK) data
from Aurinia’s AURA-LV and AURORA pivotal trials of voclosporin in
lupus nephritis (LN) were presented. The data were shared at the
American Society of Nephrology (ASN) Kidney Week 2020 in
presentations given by Brad Rovin, M.D., FASN, Director of
Nephrology and Vice Chairman of Research for the Department of
Internal Medicine at the Ohio State University Wexner Medical
Center and Teun van Gelder, Professor in Clinical Pharmacology for
the Department of Clinical Pharmacy and Toxicology at the Leiden
University Medical Center.
“People living with lupus nephritis are in a race against time
to get their disease under control with the goal of improving their
long term kidney health. We are pleased that the pooled analysis
from our AURA-LV and AURORA pivotal trials further underscores
voclosporin’s potential as an important tool to help people quickly
change the course of their disease,” said Neil Solomons, M.D.,
Chief Medical Officer of Aurinia. “Together with the supportive
pharmacokinetic data, these findings add to the growing body of
information available on voclosporin as an investigational drug
that could provide an important treatment approach for people
dealing with LN.”
Data from a total of 534 patients from AURA-LV and AURORA was
integrated and presented, demonstrating that 268 patients with LN
treated with voclosporin in combination with mycophenolate mofetil
(MMF) and low-dose steroids achieved statistically superior and
faster Renal Response rates compared to 266 patients treated with
MMF and steroids alone. The effects were also observed in Hispanic
patients, a high-risk lupus nephritis population. Treatment with
voclosporin resulted in clinically meaningful and a statistically
significant higher Renal Response rate of 43.7% compared to 23.3%
in the control arm at one year (OR 2.76, 95% CI: 1.88, 4.05; p <
0.0001) and at six months (voclosporin 31.7%; placebo 20.3%), [OR:
2.01; 95% CI: 1.34, 3.01; p=0.0008].
The Company also presented PK data analyzed from the AURA-LV and
AURORA studies further supporting the potential to eliminate the
need for therapeutic drug monitoring. The influence of various
covariates on voclosporin’s PK was evaluated based on a population
PK model and calcineurin inhibition was estimated using
concentration data in the LN population and previously measured
inhibition. At the recommended therapeutic dose of 23.7 mg twice
daily, sex, body weight, race, age, serum albumin, total bilirubin
and estimated glomerular filtration rate (eGFR) demonstrated no
clinically relevant effect on voclosporin’s PK parameters.
Voclosporin was shown to inhibit calcineurin in a dose-dependent
manner. In a quartile exposure analysis, no relationship with the
odds ratio for renal response was observed and favored voclosporin
in all quartiles. The linear PK profile of voclosporin allows the
use of a pharmacodynamic approach instead of a pharmacokinetic
approach, in which the dose of voclosporin is adjusted in response
to decreases in eGFR.
The AURA-LV and AURORA studies were of similar design and
conducted in comparable patient populations. The data from both
studies for subjects treated with the recommended voclosporin dose
of 23.7 mg twice daily (AURORA; n=179, AURA-LV; n=89) or with
matching placebo (AURORA; n= 178, AURA-LV; n=88) were therefore
pooled for an integrated analysis.
The data presented at ASN Kidney Week 2020 was submitted as part
of voclosporin’s new drug application (NDA) to the United States
Food and Drug Administration (FDA). The FDA accepted the NDA,
agreed to Priority Review, and has assigned a Prescription Drug
User Fee Act (PDUFA) target action data of January 22, 2021.
About Aurinia
Aurinia Pharmaceuticals is a late-stage clinical
biopharmaceutical company focused on developing and commercializing
therapies to treat targeted patient populations that are impacted
by serious diseases with a high unmet medical need. The Company is
currently seeking FDA approval of voclosporin for the potential
treatment of LN and evaluating voclosporin ophthalmic solution in a
Phase 2/3 study for the treatment of dry eye syndrome. The
Company’s head office is in Victoria, British Columbia and its U.S.
commercial hub is in Rockville, Maryland. The Company focuses its
development efforts globally.
Forward-Looking Statements
Certain statements made in this press release may constitute
forward-looking information within the meaning of applicable
Canadian securities law and forward-looking statements within the
meaning of applicable United States securities law. These
forward-looking statements or information include but are not
limited to statements or information with respect to: the Company’s
belief that the voclosporin efficacy and PK data from the
integrated analysis of the AURA-LV and AURORA studies supports
consistent dose-response, has the potential to eliminate the need
for therapeutic drug monitoring, underscores voclosporin as a
potentially important tool to help people quickly change the course
of their disease, and could provide an important treatment approach
for people dealing with LN; the Company’s PDUFA target action data
of January 22, 2021; and the potential FDA approval of voclosporin
as a potential treatment for LN. It is possible that such results
or conclusions may change based on further analyses of these data.
Words such as “anticipate”, “will”, “believe”, “estimate”,
“expect”, “intend”, “target”, “plan”, “goals”, “objectives”, “may”
and other similar words and expressions, identify forward-looking
statements. We have made numerous assumptions about the
forward-looking statements and information contained herein,
including among other things, assumptions about: the market value
for the LN and DES programs; that another company will not create a
substantial competitive product for Aurinia’s LN and DES business
without violating Aurinia’s intellectual property rights; the burn
rate of Aurinia’s cash for operations; the costs and expenses
associated with Aurinia’s clinical trials; the planned studies
achieving positive results; Aurinia being able to extend and
protect its patents on terms acceptable to Aurinia; and the size of
the LN, DES or proteinuric kidney disease markets; Aurinia will be
able to obtain all necessary regulatory approvals for
commercialization of voclosporin for use in LN on terms that are
acceptable to it and that are commercially viable; and that
Aurinia’s intellectual property rights are valid and do not
infringe the intellectual property rights of other parties. Even
though the management of Aurinia believes that the assumptions
made, and the expectations represented by such statements or
information are reasonable, there can be no assurance that the
forward-looking information will prove to be accurate.
Forward-looking information by their nature are based on
assumptions and involve known and unknown risks, uncertainties and
other factors which may cause the actual results, performance or
achievements of Aurinia to be materially different from any future
results, performance or achievements expressed or implied by such
forward-looking information. Should one or more of these risks and
uncertainties materialize, or should underlying assumptions prove
incorrect, actual results may vary materially from those described
in forward-looking statements or information. Such risks,
uncertainties and other factors include, among others, the
following: difficulties, delays, or failures we may experience in
the conduct of our clinical trial; difficulties we may experience
in completing the development and commercialization of voclosporin;
the market for the LN, DES and other proteinuric kidney disease
business may not be as estimated; Aurinia may have to pay
unanticipated expenses; estimated costs for clinical trials may be
underestimated, resulting in Aurinia having to make additional
expenditures to achieve its current goals; Aurinia not being able
to extend or fully protect its patent portfolio for voclosporin;
competitors may arise with similar products; Aurinia may not be
able to obtain necessary regulatory approvals for commercialization
of voclosporin in a timely fashion, or at all; Aurinia may not be
able to obtain sufficient supply to meet commercial demand for
voclosporin in a timely fashion; the unknown impact and
difficulties imposed by the COVID-19 pandemic on our business
operations including nonclinical, clinical, regulatory and
commercial activities; and our assets or business activities may be
subject to disputes that may result in litigation or other legal
claims.. Although we have attempted to identify factors that would
cause actual actions, events or results to differ materially from
those described in forward-looking statements and information,
there may be other factors that cause actual results, performances,
achievements or events to not be as anticipated, estimated or
intended. Also, many of the factors are beyond our control. There
can be no assurance that forward-looking statements or information
will prove to be accurate, as actual results and future events
could differ materially from those anticipated in such statements.
Accordingly, you should not place undue reliance on forward-looking
statements or information.
Except as required by law, Aurinia will not update
forward-looking information. All forward-looking information
contained in this press release is qualified by this cautionary
statement. Additional information related to Aurinia, including a
detailed list of the risks and uncertainties affecting Aurinia and
its business can be found in Aurinia’s most recent Annual
Information Form available by accessing the Canadian Securities
Administrators’ System for Electronic Document Analysis and
Retrieval (SEDAR) website at www.sedar.com or the U.S. Securities
and Exchange Commission’s Electronic Document Gathering and
Retrieval System (EDGAR) website at www.sec.gov/edgar.
We seek safe harbour.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201022006147/en/
Investors & Corporate: Glenn Schulman, PharmD, MPH
Corporate Communications, Aurinia gschulman@auriniapharma.com
Media Stefan Riley Ten Bridge Communications
stefan@tenbridgecommunications.com
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