VICTORIA, British Columbia--(BUSINESS WIRE)--Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH / TSX:AUP) (“Aurinia” or the “Company”), a clinical stage biopharmaceutical company focused on the global immunology market, today announced top-line results from its Phase IIb AURA-LV (AURA) study in lupus nephritis (LN). At 48 weeks, the trial met the complete and partial remission (“CR”/ “PR”) endpoints, demonstrating statistically significantly greater CR and PR in patients in both low dose (23.7mg of voclosporin twice daily (p<.001)) and high dose (39.5mg twice daily (p=.026)) cohorts versus the control group.
Each arm of the study included the current standard of care of mycophenolate mofetil (MMF) as background therapy and a forced steroid taper to 5mg/day by week 8 and 2.5mg by week 16. No unexpected safety signals were observed and there were no additional deaths in the voclosporin treated patients; however, there were three deaths and one malignancy reported in the control arm after completion of the study treatment period. Additional data analyses for the AURA study at 48 weeks will be released at future corporate, medical and scientific meetings.
“Lupus nephritis (LN) is one of the most severe complications of systemic lupus erythematosus. The current treatments of LN are toxic and the complete renal response rates are unacceptably low. For the last several years the community of lupus researchers in collaboration with the pharmaceutical industry have been engaged in finding more effective therapies for LN, but success has been difficult to achieve,” said Brad Rovin, MD, FASN, Director of Nephrology and Vice Chairman of Research for the Department of Internal Medicine at the Ohio State University Wexner Medical Center. “The AURA trial’s long-term results convincingly demonstrate that the addition of voclosporin to standard of care treatment is superior to standard of care alone. These data are not only statistically significant, but clinically important. Twice as many patients given 23.7mg voclosporin twice daily achieved a complete renal response compared to those treated with placebo. This is an impressive renal response rate and these results may shift the treatment paradigm of LN. Based on these encouraging data, I am looking forward to the Phase III trial of voclosporin in LN.”
The 24 and 48-week top-line efficacy results are summarized below:
| Endpoint | Treatment | 24 weeks | Odds ratio | P-value* | 48 weeks | Odds Ratio | P-value* | |||||||
|
Complete |
23.7mg VCS BID | 33% | 2.03 | p=.045 | 49% | 3.21 | p<.001 | |||||||
| 39.5mg VCS BID | 27% | 1.59 | p=.204 | 40% | 2.10 | p=.026 | ||||||||
| Control Arm | 19% | NA | NA | 24% | NA | NA | ||||||||
| Partial Remission | 23.7mg VCS BID | 70% | 2.33 | p=.007 | 68% | 2.34 | p=.007 | |||||||
| 39.5mg VCS BID | 66% | 2.03 | p=.024 | 72% | 2.68 | p=.002 | ||||||||
| Control Arm | 49% | NA | NA | 48% | NA | NA |
*All p-values are vs control
“We are grateful to both the patients and investigators who have worked with us on this groundbreaking program. Voclosporin is the first and only treatment candidate that has demonstrated such a clear treatment effect for LN patients,” said Neil Solomons, MD, Aurinia’s Chief Medical Officer. “These data provide us with tremendous confidence that we can execute a successful Phase III program and make a meaningful impact on patients’ lives.”
“Lupus nephritis carries with it life-threatening complications, including kidney failure. The treatment of the disease is challenging, and steroid side-effects are often difficult for patients to endure. The National Kidney Foundation supports the development of steroid-sparing treatment options, and we look forward to following the results of the Phase III trial,” said Joseph Vassalotti, MD, Chief Medical Officer, National Kidney Foundation.
Conference Call and Webcast Details
Aurinia will host a
conference call and webcast tomorrow, March 2, 2017 at 8:30am Eastern
Standard Time to provide an overview of the AURA 48-week top-line
results. In order to participate in the conference call, please dial
+1-877-407-9170 (Toll-free U.S. & Canada). An audio webcast can be
accessed under "News/Events” through the “Investors” section of the
Aurinia corporate website at www.auriniapharma.com.
A replay of the webcast will be available on Aurinia’s website.
About AURA-LV
The AURA–LV study (Aurinia Urinary
protein Reduction in Active Lupus with Voclosporin) is a 48-week study
comparing the efficacy of two doses of voclosporin added to current
standard of care of MMF against standard of care with placebo in
achieving CR in patients with active LN. All arms also received low
doses of corticosteroids as background therapy. 265 patients were
enrolled at centers in 20 countries worldwide. On entry to the study,
patients were required to have a diagnosis of LN according to
established diagnostic criteria (American College of Rheumatology) and
clinical and biopsy features indicative of highly active nephritis. The
24-week primary and secondary endpoints were released in Q3 2016 where
the primary and all secondary endpoints were met. CR is a composite
endpoint that includes: confirmed UPCR of ≤0.5 mg/mg; normal, stable
renal function (≥60 mL/min/1.73m2 or no confirmed decrease
from baseline in eGFR of ≥20%); presence of sustained, low dose steroids
(≤10mg prednisone from week 16-24); and no administration of rescue
medications. PR in the trial is measured by a ≥50% reduction in UPCR
with no concomitant use of rescue medication.
About Voclosporin
Voclosporin, an investigational
drug, is a novel and potentially best-in-class calcineurin inhibitor
(“CNI”) with clinical data in over 2,200 patients across 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. It is made by a modification of a single
amino acid of the cyclosporine molecule which has shown a more
predictable pharmacokinetic and pharmacodynamic relationship, an
increase in potency, an altered metabolic profile, and potential for
flat dosing. The Company anticipates that upon regulatory approval,
patent protection for voclosporin will be extended in the United States
and certain other major markets, including Europe and Japan, until at
least October 2027 under the Hatch-Waxman Act and comparable laws in
other countries.
About Lupus Nephritis (LN)
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.
About Aurinia
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 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 ability to execute a successful Phase III program and
voclosporin potentially shifting the treatment paradigm for LN,
Aurinia's analysis, assessment and conclusions of the results of the
AURA-LV clinical study. 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 the AURA-LV clinical study 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, except as required by law.
