- Study demonstrated a favorable risk/benefit
profile over a three-year period, with safety comparable to AURORA
1, and sustained efficacy -
- Topline results show sustained meaningful
reductions in proteinuria compared to mycophenolate mofetil (MMF)
and low-dose oral corticosteroids alone, the active study control
-
- Similar to the active control, the
voclosporin-treated group maintained stable renal function at the
end of the study -
- Aurinia to host conference call today,
December 9, at 8:30 a.m. EST -
Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (Aurinia or the
Company), a biopharmaceutical company committed to delivering
therapeutics that change the course of autoimmune disease, today
announced positive topline results from the AURORA 2 continuation
study evaluating the long-term safety and tolerability of LUPKYNIS™
(voclosporin) for the treatment of adults with active lupus
nephritis (LN), a serious complication in patients with systemic
lupus erythematosus (SLE). In combination with background
immunosuppressive therapy, LUPKYNIS is the first and only
FDA-approved medicine with three years of pivotal trial results,
including long-term safety data, within LN.
“Up to half of patients with systemic lupus erythematosus will
develop lupus nephritis, that can result in severe and permanent
damage to the kidneys and, in some cases, renal failure,” said Amit
Saxena, M.D., assistant professor, department of medicine at NYU
Langone Medical Center and an investigator in the AURORA 2 study.
“These highly anticipated long-term results, of voclosporin in
adult patients with LN, show consistent safety with the phase 3
AURORA 1 study and a benign impact on eGFR even after up to three
years of treatment while maintaining the impressive reductions in
proteinuria seen in AURORA 1.”
“We are pleased by the final results of the AURORA 2
continuation study evaluating LUPKYNIS for the treatment of lupus
nephritis, which supports the long-term safety and tolerability for
up to three years,” said Neil Solomons, M.D., Chief Medical Officer
of Aurinia. “Furthermore, we observed that efficacy was maintained
in combination with MMF and low-dose steroids.”
Highlights of topline results from AURORA 2:
- In the 116 subjects in the voclosporin-treated group who
enrolled in AURORA 2, mean estimated glomerular filtration rate
(eGFR) was stable over 36 months.
- Compared to the active control group, the voclosporin-treated
group showed an increase from baseline eGFR at the end of the
studies of +2.7 mL/min.
- The drug was well tolerated with no unexpected safety signals
observed. There were comparable serious adverse events (SAEs) rates
in both arms (19% voclosporin vs. 24% control).
- The active control group had a higher percentage of withdrawals
compared to the voclosporin-treated group, 15.0% vs. 12.9%
respectively.
- There were four deaths during AURORA 2 in the active control
group, none in the voclosporin-treated group.
- The mean Urine Protein Creatinine Ratio (UPCR) was lower in the
voclosporin-treated groups at all time points during the three
years.
“Aurinia’s LN clinical program, including AURA-LV and both the
AURORA trials, represents the largest successful LN program to
date. The latest results, featuring consistent outcomes over three
years, serve to reinforce LUPKYNIS as a safe and effective,
important treatment option for patients living with lupus
nephritis,” said Peter Greenleaf, President and CEO of Aurinia. “On
behalf of Aurinia, I extend our deepest gratitude to the
participants, their families, and the health care providers
involved in these studies.”
Aurinia also announced the initiation of ENLIGHT-LN, a
U.S.-based prospective, observational registry of adult patients
with LN treated with LUPKYNIS. The registry is intended to support
the interests of patients, clinicians, regulatory bodies, payers
and industry by obtaining longitudinal data on LUPKYNIS. The
Company aims to initiate approximately 75 sites across the U.S.
Additional details regarding this registry will be provided in
2022.
Aurinia will host a conference call on Thursday, December 9
at 8:30 am EST to review these AURORA 2 topline results. The
audio webcast can be accessed under "News/Events” through the
“Investors” section of the Aurinia corporate website at
www.auriniapharma.com or by dialing +1-877-407-9170
(Toll-free U.S. & Canada).
AURORA 2 Study Design 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 MMF/steroids. 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 MMF at 1 g twice daily with low-dose oral steroids, for up to
an additional 24 months. A total of 216 LN patients out of 357 who
were enrolled in the AURORA 1 study continued into AURORA 2, with
116 patients in the voclosporin-treated group and 100 patients in
the active control group. 90 and 78 patients, respectively,
received 36 months of total treatment at the completion of the
study. Results from the completed Phase 3 randomized, double-blind,
placebo-controlled, multicenter AURORA 1 study (NCT03021499) were
recently published in The Lancet.
About Lupus Nephritis LN is a serious manifestation of
SLE, a chronic and complex autoimmune disease. About
200,000-300,000 people live with SLE in the U.S. and approximately
up to half 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 Caucasian individuals.
About LUPKYNIS LUPKYNIS is the first FDA-approved oral
medicine for the treatment of adult patients with active 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
CNI-immunosuppressive treatments.
About Aurinia 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. In January 2021, the Company
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. Follow us on Twitter at
@AuriniaPharma and on LinkedIn.
INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATIONS
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
situation.
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.
CONTRAINDICATIONS
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
nephrotoxicity.
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
of LUPKYNIS.
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.
ADVERSE REACTIONS
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.
SPECIFIC POPULATIONS
Pregnancy/Lactation: May cause fetal harm. Advise not to
breastfeed.
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211209005485/en/
Media: Dana Lynch Corporate Communications, Aurinia
dlynch@auriniapharma.com
Investors: IR@auriniapharma.com
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