2023-04-05 07:07:11 ET
Aurinia Pharmaceuticals ( NASDAQ: AUPH ) said biopsy data collected from its phase 3 program AURORA showed promising long term results for its oral drug Lupkynis to treat adults with active lupus nephritis (LN).
LN is a type of kidney disease caused by systemic lupus erythematosus (SLE) or lupus an autoimmune disease.
The company said repeat biopsies were collected from selected patients in both treatment groups — the active control group wherein patients were given only mycophenolate mofetil (MMF) and steroids; and the study group, in which patients were on Lupkynis (voclosporin) in combination with MMF and steroids. The phase 3 program included the AURORA 1 and AURORA 2 studies.
Patients on Lupkynis showed histologic activity improvement with stable chronicity scores similar to the group on MMF and low dose steroids alone, over the 18-months average treatment period at the time of repeat biopsy, the company added.
"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," said Greg Keenan, chief medical officer, Aurinia.
Repeat renal biopsies were taken from 16 patients in the Lupkynis group and 10 patients in the active control group over 18 months from study entry.
The company noted that in the AURORA studies, Lupkynis added on top of the then current standard of care MMF and low-dose steroids, led to significantly earlier and greater reductions in proteinuria while maintaining stable kidney function, as seen by a stable estimated glomerular filtration rate (eGFR) slope over time.
AUPH +1.77% to $10.33 premarket April 5
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Aurinia's Lupkynis shows promise in 18-month kidney biopsy data