- Individuals treated with LUPKYNIS sustained
meaningful reductions in proteinuria with no change in mean eGFR at
104 weeks of treatment -
- These data, the longest-available outcomes
data with LUPKYNIS for the treatment of lupus nephritis to-date,
will be presented at European Alliance of Associations for
Rheumatology (EULAR) 2021 Congress June 2-5, 2021 -
- An additional EULAR presentation will
highlight real-world evidence suggesting reduced economic burden to
healthcare payers when achieving lower lupus nephritis (LN) disease
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (Aurinia
or the Company) announced today that a supportive interim analysis
of its AURORA 2 continuation study will be presented at the
upcoming European Alliance of Associations for Rheumatology (EULAR)
2021 Congress June 2-5, 2021.
Subjects who completed one year of treatment in Aurinia’s Phase
3 AURORA study (AURORA 1) were eligible to enroll in the two-year,
blinded, controlled continuation study (AURORA 2). The interim
analysis to be presented at EULAR evaluated subjects with up to two
years of total treatment: one year from AURORA 1 and up to one year
in AURORA 2. Previously reported results from AURORA 1 and the
Phase 2 AURA-LV study showed that compared with mycophenolate
mofetil (MMF) and low-dose steroids alone, the addition of
voclosporin significantly increased the renal response rate and
reduced proteinuria, as measured by urine protein creatinine ratio
(UPCR), in subjects with lupus nephritis (LN) at approximately one
year of treatment (48 weeks in AURA-LV and 52 weeks in AURORA 1).
The interim analysis of AURORA 2 showed that subjects in the
LUPKYNIS treatment arm sustained meaningful reductions in
proteinuria, with no change in mean estimated glomerular filtration
rate (eGFR) at 104 weeks of treatment.
“Following the enhanced renal response rates achieved in AURORA
1, these additional data show that LUPKYNIS also provides the
ability to sustain positive outcomes over time,” said Amit Saxena,
M.D., Assistant Professor at the Department of Medicine at NYU
Langone Medical Center. “The strong and growing pool of data
available on LUPKYNIS clearly demonstrates the clinical value and
safety of this therapy for a patient population that has
historically been challenged with a lack of effective treatment
An interim analysis of the 216 blinded AURORA 2 study subjects
(116 voclosporin; 100 control arm) was performed as part of the US
New Drug Application. Data from 124 subjects (73 voclosporin; 51
control arm) who had received 104 weeks of continuous treatment was
analyzed. Proteinuria continued to improve with a greater reduction
in UPCR from pre-treatment baseline to year two observed in the
voclosporin arm compared to the control arm (-3.1 vs -2.1 mg/mg;
p=0.0004). A greater reduction in proteinuria between arms was also
observed between 1 and 2 years (1.0 vs 0.6 mg/mg; voclosporin vs
control). Renal function as determined by eGFR remained stable over
104 weeks in both groups compared to baseline assessments. Mean
eGFR: 79.6 vs 79.0 mL/min for the voclosporin arm and 78.9 vs 82.9
mL/min for the control arm.
Additionally, there were no unexpected new AEs observed in
patients who continued with voclosporin treatment compared to
control-treated patients for more than one year.
“Seeing these first results from our continuation study is
extremely encouraging as we continue to work to bring LUPKYNIS to
patients following its FDA approval earlier this year,” said Neil
Solomons, M.D., Chief Medical Officer at Aurinia. “We look forward
to providing updates on our continuation study results and
continuing to support patients and physicians in making informed
decisions about the treatment of LN.”
About Lupus Nephritis
Lupus nephritis is a serious manifestation of systemic lupus
erythematosus (SLE), a chronic and complex autoimmune disease.
About 200,000-300,000 people live with SLE in the U.S. and
approximately one out of three of these individuals develop LN. If
poorly controlled, LN can lead to permanent and irreversible tissue
damage within the kidney, resulting in kidney failure. Black and
Asian individuals with SLE are four times more likely to develop LN
and individuals of Hispanic ancestry are approximately twice as
likely to develop the disease when compared with Caucasian
individuals. Black and Hispanic individuals with SLE also tend to
develop LN earlier and have poorer outcomes when compared to
LUPKYNIS is the first FDA-approved oral treatment for the
treatment of adult patients with active LN. A novel, structurally
modified calcineurin inhibitor (CNI), LUPKYNIS has a dual mechanism
of action, acting as an immunosuppressant through inhibition of
T-cell activation and cytokine production and promoting podocyte
stability in the kidney. The recommended starting dose of LUPKYNIS
is three capsules twice daily with no requirement for serum drug
monitoring. Dose modifications can be made based on Aurinia’s
proprietary personalized eGFR based dosing protocol. Boxed Warning,
warnings and precautions for LUPKYNIS are consistent with those of
other CNI-immunosuppressive treatments.
Aurinia Pharmaceuticals is a fully integrated biopharmaceutical
company focused on delivering therapies to treat targeted patient
populations that are impacted by serious diseases with a high unmet
medical need. The Company’s head office is in Victoria, British
Columbia, its U.S. commercial hub is in Rockville, Maryland, and
the Company focuses its development efforts globally.
INDICATION AND IMPORTANT SAFETY INFORMATION
LUPKYNIS is indicated in combination with a background
immunosuppressive therapy regimen for the treatment of adult
patients with active LN. Limitations of Use: Safety and efficacy of
LUPKYNIS have not been established in combination with
cyclophosphamide. Use of LUPKYNIS is not recommended in this
IMPORTANT SAFETY INFORMATION
BOXED WARNINGS: MALIGNANCIES AND SERIOUS INFECTIONS
Increased risk for developing malignancies and serious
infections with LUPKYNIS or other immunosuppressants that may lead
to hospitalization or death.
LUPKYNIS is contraindicated in patients taking strong CYP3A4
inhibitors because of the increased risk of acute and/or chronic
nephrotoxicity, and in patients who have had a serious/severe
hypersensitivity reaction to LUPKYNIS or its excipients.
WARNINGS AND PRECAUTIONS
Lymphoma and Other Malignancies: Immunosuppressants, including
LUPKYNIS, increase the risk of developing lymphomas and other
malignancies, particularly of the skin. The risk appears to be
related to increasing doses and duration of immunosuppression
rather than to the use of any specific agent.
Serious Infections: Immunosuppressants, including LUPKYNIS,
increase the risk of developing bacterial, viral, fungal, and
protozoal infections (including opportunistic infections), which
may lead to serious, including fatal, outcomes.
Nephrotoxicity: LUPKYNIS, like other CNIs, may cause
acute and/or chronic nephrotoxicity. The risk is increased when
CNIs are concomitantly administered with drugs associated with
Hypertension: Hypertension is a common adverse reaction
of LUPKYNIS therapy and may require antihypertensive therapy.
Neurotoxicity: LUPKYNIS, like other CNIs, may cause a
spectrum of neurotoxicities: severe include posterior reversible
encephalopathy syndrome (PRES), delirium, seizure, and coma; others
include tremor, paresthesia, headache, and changes in mental status
and/or motor and sensory functions.
Hyperkalemia: Hyperkalemia, which may be serious and
require treatment, has been reported with CNIs, including LUPKYNIS.
Concomitant use of agents associated with hyperkalemia may increase
the risk for hyperkalemia.
QTc Prolongation: LUPKYNIS prolongs the QTc interval in a
dose-dependent manner when dosed higher than the recommended lupus
nephritis therapeutic dose. The use of LUPKYNIS in combination with
other drugs that are known to prolong QTc may result in clinically
significant QT prolongation.
Immunizations: Avoid the use of live attenuated vaccines
during treatment with LUPKYNIS. Inactivated vaccines noted to be
safe for administration may not be sufficiently immunogenic during
treatment with LUPKYNIS.
Pure Red Cell Aplasia: Cases of pure red cell aplasia
(PRCA) have been reported in patients treated with another CNI
immunosuppressant. If PRCA is diagnosed, consider discontinuation
Drug-Drug Interactions: Avoid co-administration of LUPKYNIS and
strong CYP3A4 inhibitors or with strong or moderate CYP3A4
inducers. Reduce LUPKYNIS dosage when co-administered with moderate
CYP3A4 inhibitors. Reduce dosage of certain P-gp substrates with
narrow therapeutic windows when co-administered.
The most common adverse reactions (>3%) were glomerular filtration rate decreased,
hypertension, diarrhea, headache, anemia, cough, urinary tract
infection, abdominal pain upper, dyspepsia, alopecia, renal
impairment, abdominal pain, mouth ulceration, fatigue, tremor,
acute kidney injury, and decreased appetite.
Pregnancy/Lactation: May cause fetal harm. Advise not to
Renal Impairment: Not recommended in patients with
baseline eGFR ≤45 mL/min/1.73 m2 unless benefit exceeds risk.
Severe renal impairment: Reduce LUPKYNIS dose.
Mild and Moderate Hepatic Impairment: Reduce LUPKYNIS
dose. Severe hepatic impairment: Avoid LUPKYNIS use.
Please see Prescribing Information, including Boxed
Warning, and Medication Guide for LUPKYNIS.
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: Aurinia’s
estimates as to the number of patients with SLE in the U.S. and the
proportion of those persons who will develop LN; the estimated
proportion of Black and Asian individuals, and individuals with
Hispanic ancestry, compared to Caucasian individuals, to develop
LN; Aurinia enhancing access with a variety of patient services and
healthcare engagement initiatives. 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 accuracy of
the results from our clinical trials; and the accuracy of reported
data from third party studies and reports. 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: we may experience in completing the
commercialization of voclosporin; the market for the LN business
may not be as estimated; and the results from our clinical studies
and from third party studies and reports may not be accurate.
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.
All forward-looking information contained in this presentation
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 report on Form 10-K available by
accessing the U.S. Securities and Exchange Commission’s Electronic
Document Gathering and Retrieval System (EDGAR) website at
www.sec.gov/edgar or the Canadian Securities Administrators’ System
for Electronic Document Analysis and Retrieval (SEDAR) website at
version on businesswire.com: https://www.businesswire.com/news/home/20210520005968/en/
Investors: Glenn Schulman, PharmD, MPH Investor Relations
& Corporate Communications, Aurinia email@example.com
Corporate: Dana Lynch Corporate Communications, Aurinia
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