Dr. Neil
Solomons reports
AURINIA PRESENTS ADDITIONAL DATA FROM PHASE IIB AURA-LV STUDY, DEMONSTRATING STABLE RENAL FUNCTION AND BLOOD PRESSURE WITHOUT ELECTROLYTE COMPLICATIONS THROUGH 48 WEEKS
Aurinia Pharmaceuticals Inc. has presented additional data from its global
phase IIB AURA-LV study in lupus nephritis (LN) during the 54th
European Renal Association/European Dialysis and Transplant Association
Congress (ERA-EDTA) in Madrid, Spain. The data were presented on June 4, 2017, during the late-breaking session by lead author Dr. James Tumlin, MD, a
clinical investigator for the study and founder of Southeast Renal
Research Institute.
As previously reported, treatment with low-dose voclosporin showed
statistically improved efficacy over the control arm at 24 weeks and 48 weeks.
These results were achieved in the presence of low doses of
corticosteroids. Furthermore, all key prespecified secondary end points
analyzed to date were met at 48 weeks. The data presented at ERA-EDTA
demonstrated this improved efficacy was attained while maintaining
stable serum magnesium, potassium and blood pressure levels. Well-known
side effects with other calcineurin inhibitors at their effective dose
include hypomagnesemia and hyperkalemia, which are associated with renal
impairment and require monitoring or intervention.
"We were very encouraged to observe that voclosporin therapy resulted in
significantly improved remission rates without compromising renal
function and blood pressure or inducing electrolyte disorders," stated
Dr. James Tumlin, principal investigator. "Prolonged steroid therapy for lupus
nephritis is associated with unwanted side effects, and a reduction in
steroid dose should be a treatment goal. These encouraging data suggest
that voclosporin can induce clinical remissions with low-dose steroids
while minimizing renal toxicity."
"Interestingly, voclosporin may involve a selective mechanism of action
(which could explain the apparent improvement of blood pressure at 48
weeks from baseline, stable renal function) and the absence of
hyperkalemia and hypomagnesemia over the treatment period. Further
studies are needed to delineate this potential mechanism," said Dr. Neil
Solomons, MD, Aurinia's chief medical officer. "The data provides us
with a high degree of confidence that we can execute a successful phase
III program and make a meaningful impact on patients' lives."
All arms of the study included the current standard of care of
mycophenolate mofetil (MMF) as background therapy and an aggressive
steroid taper. Both doses of voclosporin at 48 weeks demonstrated
continued improvement over the control group across multiple measures.
The voclosporin-treated groups demonstrated statistically significant
improvement in speed and rates of complete remission (CR) and partial remission (PR). Of the low-dose voclosporin patients that achieved CR
at 24 weeks, 100 per cent remained in CR at 48 weeks, demonstrating durability
of clinical response. Proteinuria levels and reduction in Systemic Lupus
Erythematosus Disease Activity Index (SLEDAI) scores, which include
non-renal measures of lupus activity, also continued to significantly
improve over time versus the control group. Additional analyses are
continuing and will be presented at future medical and scientific meetings.
No unexpected safety signals or adverse events were observed, and
voclosporin was generally well tolerated, consistent with what is
expected of patients suffering from highly active LN while undergoing
immunomodulation-based therapy. In the voclosporin arms, renal function
as measured by estimated glomerular filtration rate (eGFR) was stable
and not significantly different from the control arm following the
48-week treatment period. There were no electrolyte changes in the
treatment groups, and mean blood pressure was also similar across
treatment groups through 48 weeks.
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-term 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 has been shown to
have a more predictable pharmacokinetic and pharmacodynamic
relationship, an increase in potency, an altered metabolic profile and
potential for flat dosing compared with legacy CNIs. 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 and tissue systems.
It is estimated that as many as 60 per cent of all SLE patients will
develop clinical LN requiring treatment. 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, 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 Pharmaceuticals Inc.
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, B.C., and focuses its development efforts
globally.
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