Mr. Neil Solomons reports
AURINIA RELEASES ADDITIONAL 48-WEEK DATA FROM THE AURA-LV STUDY DURING LATE-BREAKING SESSION AT THE NATIONAL KIDNEY FOUNDATION 2017 SPRING CLINICAL MEETINGS
Aurinia Pharmaceuticals Inc. has released additional 48-week results
from its global phase IIb Aura-LV (Aura) study in lupus nephritis (LN)
during the National Kidney Foundation 2017 Spring Clinical Meetings in
Orlando, Fla. In addition to the trial meeting its complete and partial
remission ("CR"/"PR") endpoints at 48 weeks, all pre-specified secondary
endpoints that have been analyzed to date were also met at 48 weeks.
These pre-specified endpoints include: time to CR and PR (speed of
remission); reduction in Systemic Lupus Erythematosus Disease Activity
Index or SLEDAI score; and reduction in urine protein creatinine ratio
(UPCR) over the 48-week treatment period. The data were presented during
the late-breaking session by lead author Dr. Samir Parikh, a clinical
investigator for the study and Assistant Professor of Clinical
Nephrology at the Ohio State University.
Each arm of the study included the current standard of care of
mycophenolate mofetil (MMF) as background therapy and a forced steroid
taper. Both doses of voclosporin at 48 weeks demonstrated continued
improvement over the control group across multiple dimensions. Notably,
the voclosporin groups demonstrated statistically significantly improved
speed and rates of CR and PR. Of the patients that achieved CR at 24
weeks, in the low-dose voclosporin group, 100% remained in CR at 48
weeks, which demonstrates durability of clinical response. Proteinuria
levels and reduction in SLEDAI scores, which include non-renal measures
of lupus activity, also continued to significantly separate over time
versus the control group. Additional analyses are ongoing and will be
presented at future medical and scientific meetings.
No unexpected safety signals were observed and voclosporin was generally
well-tolerated, with the nature of adverse events consistent with what
is expected of patients suffering from highly active LN while undergoing
immunomodulation-based therapy. In the voclosporin arms, the renal
function as measured by eGFR was stable and not significantly different
from the control arm during the 48-week treatment period. Mean blood
pressure was also similar between all treatment groups.
"The most exciting aspect of this data is that voclosporin is the first
treatment candidate to successfully meet all of its clinical endpoints
in a global, prospective LN trial," said Dr. Samir Parikh, a clinical
investigator for the study and Assistant Professor, Clinical Nephrology
at the Ohio State University. "Voclosporin, when added to standard of
care, achieved the highest complete remission rate of any global, active
LN trial, and this was accomplished with extremely low-dose steroid
exposure. The possibility of achieving a better clinical response while
avoiding the significant side effects associated with prolonged exposure
to high dose steroids has the potential to be a game-changer in the
management of LN."
"We are pleased by the recognition of the medical and scientific
communities of the AURA study results. Beyond the remission rates we've
shown with voclosporin, the significant improvement in SLEDAI scores
points towards a durable, immunological effect on a broad range of
clinically meaningful lupus outcomes," said Neil Solomons, MD, Aurinia's
Chief Medical Officer. "This data provides us with tremendous confidence
that we can execute a successful Phase III program and make a meaningful
impact on patients' lives."
The 24 and 48-week efficacy results are summarized below:
Endpoint Treatment 24 weeks P-value* 48 weeks P-value*
Complete Remission (CR) 23.7mg VCS BID 33% p=.045 49% p<.001
39.5mg VCS BID 27% p=.204 40% p=.026
Control Arm 19% NA 24% NA
Partial Remission (PR) 23.7mg VCS BID 70% p=.007 69% p=.007
39.5mg VCS BID 66% p=.024 72% p=.002
Control Arm 49% NA 48% NA
Time to CR (TTCR) [median] 23.7mg VCS BID 19.7 weeks p<.001 19.7 weeks p<.001
39.5mg VCS BID 23.4 weeks p=.001 23.4 weeks p<.001
Control Arm NA NA NA NA
Time to PR (TTPR) [median] 23.7mg VCS BID 4.1 weeks p=.002 4.3 weeks p=.005
39.5mg VCS BID 4.4 weeks P=.003 4.4 weeks p=.002
Control Arm 6.6 weeks NA 6.6 weeks NA
SLEDAI Reduction (non-renal lupus) 23.7mg VCS BID -6.3 p=.003 -7.9 p<.001
39.5mg VCS BID -7.1 p=.003 -8.3 p<.001
Control Arm -4.5 NA -5.3 NA
Reduction in UPCR 23.7mg VCS BID -3.769 mg/mg p<.001 -3.998 mg/mg p<.001
39.5mg VCS BID -2.792 mg/mg p=.006 -2.993 mg/mg p=.008
Control Arm -2.216 mg/mg NA -2.384 mg/mg NA
*All p-values are vs control
Webcast Details
Aurinia will host a webcast today, April 20,
2017 at 6:15pm Eastern Daylight Time. A live webcast of the event, with
slides, will be available on the Investors section of the Company's
website.
About Voclosporin
Voclosporin, an investigational
drug, is a novel and potentially best-in-class calcineurin inhibitor
("CNI") with clinical 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. 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)
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 LN. The company is headquartered in Victoria, BC and
focuses its development efforts globally.
We seek Safe Harbor.
© 2024 Canjex Publishing Ltd. All rights reserved.