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Aurinia Pharmaceuticals Announces Promising Topline Data from Renal Biopsy Sub-study of the AURORA Trial
Tuesday, April 18, 2023Company Profile | Follow Company
LUPKYNIS treated patients showed histologic activity improvement with stable chronicity scores similar to active control arm of mycophenolate mofetil (MMF) and low dose steroids alone
Data further reinforces differentiation of LUPKYNIS from first generation calcineurin inhibitors (CNIs)
Victoria, BC, April 18, 2023--(T-Net)--Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) has announced promising results from the AURORA Renal Biopsy Sub-Study. LUPKYNIS is a novel agent approved for the treatment of adults with active lupus nephritis (LN).
The addition of LUPKYNIS on top of the then current standard of care MMF and low-dose steroids in Aurinia's Phase 3 AURORA 1 and AURORA 2 studies led to significantly earlier and greater reductions in proteinuria while maintaining stable renal function, as evidenced by a stable estimated glomerular filtration rate (eGFR) slope over time.
To further characterize the long-term impact of LUPKYNIS on the kidney at the histologic level, repeat biopsies were collected from selected patients in both treatment arms (the active control arm with patients treated with only MMF and steroids, and the study arm of voclosporin in combination with MMF and steroids).
The patients in the voclosporin treatment arm demonstrated histologic activity improvement with stable chronicity scores similar to the active control arm of MMF and low dose steroids alone over the 18-months average treatment period at the time of repeat biopsy.
"We are encouraged by these results," said Dr. Greg Keenan, recently appointed Chief Medical Officer of Aurinia. "Seeing similar improvement in the activity scores and absence of change in the chronicity scores with the LUPKYNIS treated patients as compared to those on MMF and low dose steroids alone strengthens the totality of the evidence supporting the long-term efficacy and safety of LUPKYNIS and further differentiates the safety of this second-generation treatment from the legacy, first generation CNIs."
Repeat renal biopsies were obtained from 16 patients in the voclosporin arm and 10 patients in the active control arm over 18 months from study entry. Baseline and follow-up activity scores, a measure of active inflammation in LN, and chronicity scores, a measure of irreversible kidney injury, were obtained using a validated assessment tool. Compared to baseline, the activity scores for both LUPKYNIS and active control populations improved to a similar degree, while the chronicity scores remained stable over time in both arms.
Dr. Brad Rovin, Professor of Nephrology and Director, Division of Nephrology, Ohio State University, Wexner Medical Center
Dr. Brad Rovin, Professor of Nephrology and Director, Division of Nephrology at the Ohio State University Wexner Medical Center said, "The lack of histologic evidence of CNI nephrotoxicity and the absence of progression of chronic kidney damage after approximately 18 months of treatment further strengthen the overall evidence supporting the long-term safety of LUPKYNIS in LN patients."
Further data will be presented at the upcoming Congress of Clinical Rheumatology meeting, May 4-7, 2023.
About Lupus Nephritis
Lupus Nephritis is a serious manifestation of systemic lupus erythematosus (SLE), a chronic and complex autoimmune disease. About 200,000-300,000 people live with SLE in the U.S. and about one-third of these people are diagnosed with lupus nephritis at the time of their SLE diagnosis. About 50 percent of all people with SLE may develop lupus nephritis. If poorly controlled, lupus nephritis can lead to permanent and irreversible tissue damage within the kidney. Black and Asian people with SLE are four times more likely to develop lupus nephritis and Hispanic people are approximately twice as likely to develop the disease compared to White people with SLE. Black and Hispanic people with SLE also tend to develop lupus nephritis earlier and have poorer outcomes, compared to White people with SLE.
About LUPKYNIS
LUPKYNIS is the first U.S. FDA- and EC-approved oral medicine for the treatment of adult patients with active LN. LUPKYNIS is a novel, structurally modified calcineurin inhibitor (CNI) with a dual mechanism of action, acting as an immunosuppressant through inhibition of T-cell activation and cytokine production and promoting podocyte stability in the kidney. The recommended starting dose of LUPKYNIS is three capsules twice daily with no requirement for serum drug monitoring. Dose modifications can be made based on Aurinia's proprietary personalized eGFR-based dosing protocol. Boxed Warning, warnings, and precautions for LUPKYNIS are consistent with those of other CNI-immunosuppressive treatments.
About Aurinia
Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations with a high unmet medical need that are impacted by autoimmune, kidney and rare diseases. In January 2021, the Company introduced LUPKYNIS® (voclosporin), the first FDA-approved oral therapy dedicated to the treatment of adult patients with active lupus nephritis. The Company's head office is in Edmonton, Alberta, its U.S. commercial office is in Rockville, Maryland. The Company focuses its development efforts globally.
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: Aurinia's estimates as to annual net revenue; Aurinia's estimates as to the number of patients with SLE in the U.S. and the proportion of those persons who will develop LN; Aurinia being confident that it is well-poised for growth; Aurinia's belief that it has sufficient financial resources to fund its current plans; the expected timing for the EMA CHMP opinion and EMA decision relating to the EMA MAA; and the planned timing for reporting top-line results from the ongoing AURORA-2 continuation study. [ MORE ] |
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