- Voclosporin demonstrated fewer adverse
effects on beta cell function as compared to tacrolimus in
preclinical model of diabetes -
- Data supports differentiation of
voclosporin versus legacy CNIs and potential best-in-class
attributes -
- Data to be presented at the Keystone
Symposia Conference on Islet Cell Biology -
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX:AUP) (“Aurinia”
or the “Company”), a late-stage clinical biopharmaceutical company
focused on advancing voclosporin across multiple inflammatory and
autoimmune conditions, today announced that an abstract has been
accepted for presentation at the Keystone Symposia Conference on
Islet Biology: From Gene to Cell to Micro-Organ in Santa Fe, New
Mexico from January 27-31, 2020. The abstract will be presented by
Dr. James D. Johnson, Professor of Medicine in the Department of
Cellular and Physiological Sciences and the Department of Surgery
at the University of British Columbia (UBC). Professor Johnson is
founding member of the Life Sciences Institute Diabetes Research
Group and current Editor-in-Chief of the journal Islets.
The abstract entitled, Tacrolimus, but not voclosporin,
significantly inhibits insulin exocytosis from human islets at
clinically relevant trough concentrations, will discuss preclinical
data comparing the effects of tacrolimus and voclosporin on the
function and survival of human insulin producing beta cells. Legacy
calcineurin inhibitors (“CNIs”) have been a mainstay of treatment
for the prevention of rejection after solid organ transplant for
decades. In this setting, patients have developed new onset
diabetes after transplant (NODAT) as a relatively common but
serious side effect.1 In a past clinical study, voclosporin was
shown to be significantly less diabetogenic than tacrolimus in the
renal transplant setting.2 In the recently published AURA-LV study
in subjects with active lupus nephritis, voclosporin was shown to
have no adverse clinical impact on glucose parameters.
In this in vitro study, human islets were treated with
clinically relevant concentrations approximating the peak and
trough concentrations of tacrolimus or voclosporin. At these trough
concentrations tacrolimus, but not voclosporin, caused a
statistically significant impairment of insulin secretion at the
distal stages of exocytosis. Transcriptome sequencing identified
novel effects of calcineurin inhibitors on genes responsible for
the regulation of cellular exocytic machinery and these effects
were more marked with tacrolimus.
“We are very happy with these preclinical results,” stated Dr.
Robert Huizinga, Executive Vice President Corporate Development at
Aurinia. “These data, combined with our reported clinical
experience with voclosporin with respect to a potentially low
diabetic potential of this agent provide additional understanding
into the mechanistic rationale as to why we see a limited adverse
impact on beta cell function with voclosporin, which supports our
reported clinical experience with respect to the very low diabetic
potential of this agent.”
The results of this study will be incorporated in a potential
New Drug Application (NDA) the company expects to file during the
first half of 2020.
1. Webster et al., British Medical Journal. 2005; Oct. 8th;
331(7520); 810
2. Busque et al., American Journal of Transplantation.
2011;11(12):2675-2684
Full Presentation
Details
Title: Tacrolimus, but not voclosporin, significantly
inhibits insulin exocytosis from human islets at clinically
relevant trough concentrations (Poster #2004)
Presenter: Dr. James D. Johnson, Professor of Medicine in
the Department of Cellular and Physiological Sciences and the
Department of Surgery at the University of British Columbia
(UBC)
Date: Wednesday, January 29, 2020
Location: Santa Fe Community Convention Center - Poster
Session 2, Sweeney F, Main Level Breakout Room
About Aurinia
Aurinia Pharmaceuticals is a late clinical-stage
biopharmaceutical company focused on developing and commercializing
therapies to treat targeted patient populations that are impacted
by serious diseases with a high unmet medical need. The Company is
currently developing an investigational drug, for the treatment of
Lupus Nephritis, Focal Segmental Glomerulosclerosis and Dry Eye
Syndrome. The Company’s head office is in Victoria, British
Columbia and focuses its development efforts globally. For further
information, see our website at www.auriniapharma.com.
About Voclosporin
Voclosporin, an investigational drug, is a novel and potentially
best-in-class calcineurin inhibitor (“CNI”) with clinical data in
over 2,600 patients across indications. Voclosporin is an
immunosuppressant, with a synergistic and dual mechanism of action.
By inhibiting calcineurin, voclosporin blocks IL-2 expression and
T-cell mediated immune responses and stabilizes the podocyte in the
kidney. It has been shown to have a more predictable
pharmacokinetic and pharmacodynamic relationship (potentially
requires no therapeutic drug monitoring), an increase in potency
(vs cyclosporin), and an improved metabolic profile compared to
legacy CNIs. Aurinia 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 and until April 2028 with
anticipated pediatric extension. Further, the new Notice of
Allowance is expected to result in the issuance of a U.S. patent
with a term extending to December 2037. If the FDA approves the use
of voclosporin for LN and the label for such use follows the dosing
protocol under the Notice of Allowance, the issuance of this patent
will expand the scope of intellectual property protection for
voclosporin to December 2037.
Forward-Looking Statements
Certain statements made in this press release may constitute
forward-looking information within the meaning of applicable
Canadian securities law and forward-looking statements within the
meaning of applicable United States securities law. These
forward-looking statements or information include but are not
limited to statements or information with respect to: preclinical
data comparing the effects of tacrolimus and voclosporin on the
function and survival of human insulin producing beta cells and the
implications of such findings; voclosporin being potentially a
best-in-class CNI with robust intellectual property exclusivity;
Aurinia’s anticipation 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 and until April 2028 with anticipated
pediatric extension; that the new Notice of Allowance is expected
to result in the issuance of a U.S. patent with a term extending to
December 2037; that if the FDA approves the use of voclosporin for
LN and the label for such use follows the dosing protocol under the
Notice of Allowance, the issuance of this patent will expand the
scope of intellectual property protection for voclosporin to
December 2037. It is possible that such results or conclusions may
change based on further analyses of these data. Words such as
“anticipate”, “will”, “believe”, “estimate”, “expect”, “intend”,
“target”, “plan”, “goals”, “objectives”, “may” and other similar
words and expressions, identify forward-looking statements. We have
made numerous assumptions about the forward-looking statements and
information contained herein, including among other things,
assumptions about: the market value for the LN, DES and FSGS
programs; that another company will not create a substantial
competitive product for Aurinia’s LN, DES and FSGS business without
violating Aurinia’s intellectual property rights; the burn rate of
Aurinia’s cash for operations; the costs and expenses associated
with Aurinia’s clinical trials; the planned studies achieving
positive results; Aurinia being able to extend and protect its
patents on terms acceptable to Aurinia; and the size of the LN, DES
or FSGS markets. Even though the management of Aurinia believes
that the assumptions made, and the expectations represented by such
statements or information are reasonable, there can be no assurance
that the forward-looking information will prove to be accurate.
Forward-looking information by their nature are based on
assumptions and involve known and unknown risks, uncertainties and
other factors which may cause the actual results, performance or
achievements of Aurinia to be materially different from any future
results, performance or achievements expressed or implied by such
forward-looking information. Should one or more of these risks and
uncertainties materialize, or should underlying assumptions prove
incorrect, actual results may vary materially from those described
in forward-looking statements or information. Such risks,
uncertainties and other factors include, among others, the
following: difficulties, delays, or failures we may experience in
the conduct of our clinical trial; difficulties we may experience
in completing the development and commercialization of voclosporin;
the market for the LN, DES and FSGS business may not be as
estimated; Aurinia may have to pay unanticipated expenses;
estimated costs for clinical trials may be underestimated,
resulting in Aurinia having to make additional expenditures to
achieve its current goals; Aurinia not being able to extend or
fully protect its patent portfolio for voclosporin; and competitors
may arise with similar products. Although we have attempted to
identify factors that would cause actual actions, events or results
to differ materially from those described in forward-looking
statements and information, there may be other factors that cause
actual results, performances, achievements or events to not be as
anticipated, estimated or intended. Also, many of the factors are
beyond our control. There can be no assurance that forward-looking
statements or information will prove to be accurate, as actual
results and future events could differ materially from those
anticipated in such statements. Accordingly, you should not place
undue reliance on forward-looking statements or information.
Except as required by law, Aurinia will not update
forward-looking information. All forward-looking information
contained in this press release is qualified by this cautionary
statement. Additional information related to Aurinia, including a
detailed list of the risks and uncertainties affecting Aurinia and
its business can be found in Aurinia’s most recent Annual
Information Form available by accessing the Canadian Securities
Administrators’ System for Electronic Document Analysis and
Retrieval (SEDAR) website at www.sedar.com or the U.S. Securities
and Exchange Commission’s Electronic Document Gathering and
Retrieval System (EDGAR) website at www.sec.gov/edgar.
We seek Safe Harbor.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20191203005383/en/
Investor & Media: Glenn Schulman, PharmD, MPH
Corporate Communications, Aurinia gschulman@auriniapharma.com
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