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 24-week data in all 10 patients from the AURION study, an open-label exploratory study to assess the short-term predictors of response using voclosporin (23.7mg BID) in combination with mycophenolate mofetil (MMF) and oral corticosteroids in patients with active lupus nephritis (LN). The data are being presented by Robert Huizinga, Vice President of Clinical Affairs at Aurinia at the 10th Annual European Lupus Meeting in Venice, Italy.
The primary objective of the study is to examine biomarkers of disease activity at eight weeks and their ability to predict response at 24 and 48 weeks.
In this study, 70% (7/10) patients achieved complete remission (CR) at 24 weeks as measured by a urinary protein creatinine ratio (UPCR) of ≤ 0.5mg/mg, eGFR within 20% of baseline and concomitant steroid dose of <5mg/day. Of the 10 patients that achieved a reduction of UPCR of ≥ 25% at 8 weeks, 80% were responders (≥ 50% reduction in UPCR over baseline) at 24 weeks and 70% were in CR at 24 weeks. In addition, inflammatory markers such as C3, C4 and anti-dsDNA all continued to normalize to 24 weeks. Voclosporin was well-tolerated with no unexpected safety signals observed.
“The results of AURION provide further proof of concept data to support voclosporin’s use in the treatment of active LN and continue to indicate that 23.7mg BID is the optimal dose to advance into our phase III program,” said Neil Solomons, MD, Chief Medical Officer of Aurinia. “We are encouraged by our ability to quickly predict responses and remission rates in these patients, which can help clinicians optimize patient care and long-term outcomes.”
Details of the results are below:
| Patient # |
Attained ≥25% |
Attained
|
Attained
|
Attained
|
Attained
|
|||||
| 1 | Y | Y | Y | Y | Y | |||||
| 2 | Y | Y | Y | Y | Y | |||||
| 3 | Y | Y | Y | N | N | |||||
| 4 | Y | N | N | N | N | |||||
| 5 | Y | Y | Y | Y | Y | |||||
| 6 | Y | Y | Y | Y | Y | |||||
| 7 | Y | N | N | N | N | |||||
| 8 | Y | Y | Y | Y | Y | |||||
| 9 | Y | N | Y | N | Y | |||||
| 10 | Y | Y | Y | N | Y | |||||
| TOTALS: | 100% (10/10) | 70%(7/10) | 80% (8/10) | 50% (5/10) | 70% (7/10) |
*Retrospectively defined by ≥50% reduction in UPCR
About AURION
The AURION study or “Aurinia Early
Urinary Protein Reduction Predicts Response Study” is an open-label,
exploratory study being conducted in multiple sites in Malaysia to
assess the short term predictors of response using voclosporin (23.7mg)
in combination with mycophenolate mofetil and oral corticosteroids in
patients with active lupus nephritis. This study will examine biomarkers
of disease activity at 8 weeks and their ability to predict response at
24 and 48 weeks.
About Voclosporin
Voclosporin, an investigational
drug, is a novel and potentially best-in-class calcineurin inhibitor
(“CNI”) with clinical data in over 2,000 patients in other 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)
Lupus Nephritis (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 lupus nephritis (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 regulatory strategy (including plans to meet with the U.S.
Food and Drug Administration to discuss these data and the voclosporin’s
subsequent clinical development and path to registration in LN),
Aurinia's analysis, assessment and conclusions of the results of the
AURION clinical study, and the efficacy and commercial potential of
voclosporin. 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 AURION 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.
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