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
May
17, 2017
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
principal 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 ⃞
This Form 6-K is hereby filed and incorporated by reference into the Registrant’s Registration Statement on Form F-10 (File No. 333-206994).
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: |
May 17, 2017 |
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Aurinia Pharmaceuticals Inc. |
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By: |
/s/ Celia Economides |
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Name: |
Celia Economides |
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Title: |
Head of IR & Communications |
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EXHIBIT INDEX
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Exhibit |
Description of Exhibit |
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| 99.1 |
News Release – AURINIA DOSES FIRST PATIENT IN AURORA PHASE 3 CLINCAL TRIAL OF VOCLOSPORIN IN LUPUS NEPHRITIS |
Exhibit 99.1 included with this report on Form 6-K is hereby
incorporated by reference as an exhibit to the Registrant’s Registration
Statement on Form F-10 (File No. 333-206994), as amended or supplemented.
3
Exhibit 99.1
Aurinia Doses First Patient in AURORA Phase 3 Clinical Trial of Voclosporin in Lupus Nephritis
VICTORIA, British Columbia--(BUSINESS WIRE)--May 17, 2017--Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH/TSX:AUP) (“Aurinia” or the “Company”), a clinical stage biopharmaceutical company focused on the global immunology market, today announced that the first patient has been dosed in AURORA, the Company’s Phase 3 confirmatory clinical trial evaluating voclosporin for the treatment of lupus nephritis (LN), an autoimmune disease caused by lupus that involves extreme inflammation and failure of the kidneys.
“Dosing our first patient today is an important milestone for the Company,” said Neil Solomons, M.D., Chief Medical Officer of Aurinia. “Our Phase 3 trial design is nearly identical to that of our successful Phase 2 AURA trial which demonstrated the potential of voclosporin to increase both speed and rates of remission in patients with active LN. We remain dedicated to advancing this treatment and making a meaningful impact in the lives of patients suffering from LN and those around them.”
AURORA is a 52-week global double-blind placebo controlled study, designed to demonstrate that voclosporin added to the current standard of care of mycophenolate mofetil (MMF) can increase overall renal response rates in the presence of extremely low steroids. The primary endpoint is complete renal response at 52 weeks. This trial will recruit ~320 patients and is intended to support full marketing approval of voclosporin for patients with LN across multiple regulatory jurisdictions.
“Lupus nephritis is a devastating disease which if not managed, can be life-threatening. There is no approved medication to treat the condition which mostly affects women in their childbearing years,” said Mary Anne Dooley, M.D., M.P.H., Adjunct Professor of Medicine at University of North Carolina School of Medicine and principal investigator for the study. “The AURA Phase II results showed great promise and if replicated in Phase 3, voclosporin has the potential to change the current treatment paradigm for LN.”
About AURORA
The AURORA study is a 52-week global
double-blind placebo controlled Phase 3 study that will compare the
efficacy of one dose of voclosporin (23.7mg BID) to placebo when added
to current standard of care of mycophenolate mofetil (MMF, also known as
CellCept®) in achieving renal response (formerly referred to as complete
remission) in patients with active LN. Both arms will also receive low
doses of corticosteroids as part of background therapy after a stringent
taper. For further questions on the trial or interest in participating,
please see our website (http://www.auriniapharma.com/for-patients-physicians/clinical-trials)
or contact us at clinicaltrials@auriniapharma.com.
About Voclosporin
Voclosporin, an investigational drug,
is a novel and potentially best-in-class calcineurin inhibitor (“CNI”)
with clinical trial 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. Voclosporin is made by a modification of a
single amino acid of the cyclosporine molecule which results in a more
predictable pharmacokinetic and pharmacodynamic relationship with
potential for flat dosing. In addition, Voclosporin is more potent than
and has an improved metabolic profile versus cyclosporine. 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, an inflammation of the
kidney caused by Systemic Lupus Erythematosus (“SLE”), represents a
serious progression of SLE. SLE is a chronic, complex and often
disabling disorder that 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 a strong surrogate marker, proteinuria, which correlates
with meaningful longer term clinical outcome. 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. 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, 2016 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.
CONTACT:
Aurinia Pharmaceuticals Inc.
Investor Contact:
Celia
Economides
VP, Public Affairs
ceconomides@auriniapharma.com
or
Media
Contact:
Christopher Hippolyte, 212-364-0458
Christopher.hippolyte@inventivhealth.com