UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM 6-K
REPORT
OF FOREIGN PRIVATE ISSUER
PURSUANT
TO RULE 13A-16 OR 15D-16 UNDER THE
SECURITIES
EXCHANGE ACT OF 1934
Dated
February
8, 2016
Commission
File Number 001-36421
AURINIA PHARMACEUTICALS INC.
(Exact
name of Registrant as specified in its charter)
N/A
(Translation of Registrant’s Name)
#1203-4464 Markham Street
Victoria, British Columbia
V8Z7X8
(250)
708-4272
(Address and telephone number of registrant’s
principle executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:
Form 20-F ⃞ Form 40-F ⊠
Indicate by
check mark if the registrant is submitting the Form 6-K in paper as
permitted by Regulation S-T Rule 101(b)(1): ⃞
Indicate by
check mark if the registrant is submitting the Form 6-K in paper as
permitted by Regulation S-T Rule 101(b)(7): ⃞
Indicate by check mark whether by furnishing the information contained in this Form, the registrant is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes ⃞ No ⊠
If "Yes" is
marked, indicate below the file number assigned to the registrant in
connection with Rule 12g3-2(b): Not applicable.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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Dated: |
February 8, 2016 |
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Aurinia Pharmaceuticals Inc. |
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By: |
/s/ Michael R. Martin |
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Name: |
Michael R. Martin |
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Title: |
Chief Operating Officer |
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EXHIBIT INDEX
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Exhibit |
Description of Exhibit |
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| 99.1 |
News Release – Aurinia Announces Preliminary Topline Data From its Open Label AURION Study in Lupus Nephritis |
3
Exhibit 99.1
Aurinia Announces Preliminary Topline Data From its Open Label Aurion Study in Lupus Nephritis
100% of Patients receiving multi-target therapy with voclosporin achieved at least a 25% reduction of proteinuria at 8 weeks with a mean decrease of 72%
VICTORIA, British Columbia--(BUSINESS WIRE)--February 8, 2016--Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH / TSX:AUP) (“Aurinia” or the “Company”) announced today that it has completed a preliminary analysis of its AURION (Aurinia early Urinary protein Reduction Predicts Response) study. In the first seven patients that have reached at least eight weeks of therapy in the AURION study, 100% (7/7) have achieved at least a 25% reduction in proteinuria compared to study entry. A 25% reduction in proteinuria has been shown to be predictive of a positive clinical response at 24 weeks1. All of the other pre-specified eight week biomarkers of active lupus nephritis (LN) have also improved and are trending towards normalization. These biomarkers have also been shown to be predictive of a positive clinical response at 24 weeks1.
In the first eight weeks of a 48 week regimen of multi-target therapy including voclosporin in AURION, an overall mean reduction of proteinuria of 72% compared to pre-treatment levels was observed, and 57% (4/7) of these patients achieved complete remission as defined by a urinary protein creatinine ratio of ≤ 0.5mg/mg. Overall renal function as measured by eGFR in these patients has remained stable.
The AURION study is an open label, single arm, exploratory study assessing the ability of biomarkers at 8 weeks to predict clinical response rates at 24 and 48 weeks in subjects taking voclosporin 23.7mg twice daily in combination with standard of care, mycophenolate mofetil and corticosteroids, in patients with active LN.
“We are encouraged by these results. This is the first time voclosporin has been used in this particular patient population.” said Dr. Neil Solomons, MD, Chief Medical Officer of Aurinia Pharmaceuticals Inc. “It appears that this data supports our hypothesis that utilizing a multi-targeted approach to treating LN with voclosporin can help patients suffering from this disease. We are very excited to see the results from the 265 patient AURA study later this year.”
The Company will continue to review the AURION data and release more information as it becomes available, a webcast has been scheduled for Tuesday February 16th, 2016 at 4:30pm Eastern Standard Time. Interested parties can join the webcast at the specified time at the following URL: http://public.viavid.com/index.php?id=118297
1Dall’Era, M., Stone, D., Levesque, V., Cisternas,M., & Wofsy, D. (2011).Arthritis Care and Research, 63(3), 351–357.
About Aurinia
Aurinia is a clinical stage pharmaceutical company focused on the global nephrology market. The fully-enrolled Phase 2b AURA-LV clinical trial is evaluating the efficacy of its lead drug, voclosporin, as a treatment for active LN. LN is an inflammation of the kidneys, that if inadequately treated can lead to end-stage renal disease, making LN a serious and potentially life-threatening condition.
Voclosporin is a novel and potentially best-in-class calcineurin inhibitor (“CNI”) with extensive clinical data in over 2,000 patients in other indications. Voclosporin is made by a modification of a single amino acid of the cyclosporine molecule (a CNI approved for use in transplant patients since 1983). This modification results in a more predictable pharmacokinetic and pharmacodynamic relationship, an increase in potency vs. cyclosporine, an altered metabolic profile, and potential for flat dosing.
About AURA:
The AURA–LV study or “Aurinia Urine Protein Reduction in Active Lupus Nephritis Study” is an adequate and well-controlled clinical trial that enrolled 265 patients and is being conducted in over 20 countries worldwide. This trial will compare the efficacy of voclosporin against placebo in achieving remission in patients with active lupus nephritis. The AURA-LV study is designed to demonstrate that voclosporin can induce a rapid and sustained reduction of proteinuria in the presence of extremely low steroid exposure. It will compare two dosage groups of voclosporin (23.7mg and 39.5mg) compared to placebo, with all patients receiving mycophenolate mofetil (MMF) and oral corticosteroids as background therapy. There will be a primary analysis to determine complete remission at week 24 (confirmed at 26 weeks) and various secondary analyses at week 48 which include biomarkers and markers of non-renal SLE.
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.
We seek Safe Harbor.
CONTACT:
Aurinia Pharmaceuticals Inc.
Mr. Michael Martin,
250-708-4272
Chief Operating Officer
mmartin@auriniapharma.com
or
Renmark
Financial Communications Inc.
Barry Mire: bmire@renmarkfinancial.com
Laura
Welsh: lwelsh@renmarkfinancial.com
Tel: 416-644-2020 or
514-939-3989