- Longest available outcomes data with LUPKYNIS
will be presented virtually during American College of Rheumatology
(ACR) Convergence 2021; final results expected by the end of 2021
- Updated interim analysis shows sustained
safety and tolerability of LUPKYNIS compared with placebo -
- Individuals treated with LUPKYNIS sustained
meaningful reductions in proteinuria with stable eGFR at 30 months
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the
Company), a biopharma company committed to delivering therapeutics
that change the course of autoimmune disease, today announced
updated interim results from the AURORA 2 continuation study
evaluating the long-term safety and tolerability of LUPKYNIS™
(voclosporin) for the treatment of lupus nephritis (LN) in patients
with systemic lupus erythematosus (SLE), a chronic and complex
autoimmune disease. The updated results will be presented virtually
on Nov. 8 during Plenary Session III at 10:45 a.m. EST during The
American College of Rheumatology (ACR) Convergence 2021.
In the interim analysis, patients in the voclosporin group
maintained meaningful reductions in proteinuria. From pre-treatment
baseline in AURORA 1 to month 30 in AURORA 2, mean urine
protein/creatinine ratio (UPCR) was -3.32 mg/mg for the voclosporin
group (n=90) and -2.55 mg/mg for the control group (n=78). In the
voclosporin group, estimated glomerular filtration rate (eGFR), an
important measurement of kidney function, remained stable through
month 30. There were no unexpected new adverse events reported in
the voclosporin group compared to the control group.
“In this updated interim analysis, reductions in proteinuria
were sustained with no impact on renal function at a total of 30
months of treatment with voclosporin,” said Amit Saxena, M.D.,
assistant professor, department of medicine at NYU Langone Medical
Center and presenting author of the AURORA 2 study. “The consistent
outcomes over time reinforce confidence in LUPKYNIS as an important
treatment choice for people experiencing the dangerous
manifestation of lupus nephritis.”
AURORA 2 (NCT03597464) is a Phase 3 randomized, double-blind,
placebo-controlled clinical trial to assess the long-term safety
and tolerability of voclosporin, in addition to the standard of
care, for the treatment of LN in patients with SLE. Patients who
completed 12 months of treatment in the Phase 3 AURORA 1 study were
eligible to enroll in the AURORA 2 continuation study with the same
randomized treatment of voclosporin at 23.7 mg twice daily or
placebo, in combination with mycophenolate mofetil (MMF) at 1 g
twice daily with either no or low-dose oral steroids, for an
additional 24 months. A total of 216 LN patients continued into
AURORA 2, with 116 patients in the voclosporin group and 100
patients in the control group. 90 and 78 patients, respectively,
received 30 months of total treatment as of this interim analysis.
Final results from the AURORA 2 study are expected by the end of
2021. Results from the completed Phase 3 randomized, double-blind,
placebo-controlled, multicenter AURORA 1 study (NCT03021499) were
recently published in The Lancet.
“We are encouraged to see the continued positive outcomes with
LUPKYNIS and look forward to seeing and presenting the complete
results from AURORA 2 in the coming months,” said Neil Solomons,
M.D., Chief Medical Officer at Aurinia.
About Lupus Nephritis
Lupus nephritis (LN) 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 medicine for the
treatment of adult patients with active lupus nephritis (LN).
LUPKYNIS is a novel, structurally modified calcineurin inhibitor
(CNI) with 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
Aurinia 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 recently introduced the first FDA-approved oral therapy
indicated for the treatment of adult patients with active lupus
nephritis (LN). Aurinia’s head office is in Victoria, British
Columbia; its U.S. commercial hub is in Rockville, Maryland; and
the Company focuses 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
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 results of the
updated interim AURORA-2 continuation study; and the planned timing
for reporting top-line results from the ongoing AURORA-2
It is possible that such results or conclusions may change.
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
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: the market for the LN business may not be as estimated;
unknown impact and difficulties imposed by the COVID-19 pandemic on
Aurinia’s business operations including nonclinical, clinical,
regulatory and commercial activities; and the results from
Aurinia’s clinical studies and from third party studies and reports
may not be accurate. Although Aurinia has 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 Aurinia’s 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 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 Report on Form 10-K 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, or on Aurinia’s website at
version on businesswire.com: https://www.businesswire.com/news/home/20211101005592/en/
Media: Dana Lynch Corporate Communications, Aurinia
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