Full Press Release Details
Completes Enrollment of AURORA, its Phase 3 Clinical Trial for the
Treatment of Lupus Nephritis
enrollment has been exceeded and completed ahead of schedule
anticipates primary data analysis in Q4 2019
VICTORIA, British Columbia--(BUSINESS WIRE)--September 25, 2018--Aurinia
Pharmaceuticals Inc. (NASDAQ: AUPH/TSX:AUP), a clinical stage
biopharmaceutical company focused on the global immunology market, today
announced that it has completed enrollment for the AURORA Phase 3 trial
ahead of schedule. The target enrollment of 324 patients was surpassed
due to high patient demand with 358 lupus nephritis (LN) patients
randomized in sites across 27 countries.
"We are elated by the significant interest this trial has garnered
around the globe, which reinforces the need for new treatment options
for patients living with lupus nephritis," said Richard M. Glickman,
Aurinia's Chairman and Chief Executive Officer. "I continue to be
impressed by the level of dedication exhibited by our team to execute
this trial with great diligence and expediency."
The AURORA clinical trial is a global, double-blind, placebo-controlled
study to evaluate whether voclosporin when added to background therapy
of mycophenolate mofetil (MMF)/CellCept can increase speed of and
overall renal response rates in the presence of low dose steroids. The
primary endpoint for the study is complete renal response at 52 weeks,
after which patients can choose to enroll into a 104-week blinded
"We would like to thank our trial patients, physicians, trial site
staff, and advocacy groups for their extraordinary efforts which has led
to this result," said Neil Solomons, M.D., Aurinia's Chief Medical
Officer. "We look forward to sharing the results of the trial in late Q4
2019 and to completing our NDA submission in Q2 2020."
Aurinia Pharmaceuticals 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 potential treatment of lupus nephritis,
focal segmental glomerulosclerosis, and dry eye syndrome. The company is
headquartered in Victoria, British Columbia and focuses its development
efforts globally. For further information, see our website at www.auriniapharma.com.
Voclosporin, an investigational drug, is a novel and potentially
best-in-class CNI with clinical data in over 2,400 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 (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.
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. The disease is
highly heterogeneous, affecting a wide range of organs & tissue systems.
Unlike SLE, LN has straightforward disease outcomes (measuring
proteinuria) where an early response correlates with long-term outcomes.
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.
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: AURORA having data in Q4 2019 , completing
NDA submissions in a successful and timely manner, voclosporin being
potentially a best-in-class CNI with robust intellectual property
exclusivity. 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 program; that another company will not create a substantial
competitive product for Aurinia's LN 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 its patents on terms acceptable to Aurinia; and the
size of the LN market. 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.
Aurinia Pharmaceuticals
VP, Corporate & Public Affairs
Christopher Hippolyte, 212-364-0458