Aurinia Pharma Reports Promising Topline Data From AURORA Renal Biopsy Sub-Study

(RTTNews) - Aurinia Pharmaceuticals Inc. (AUPH) announced Wednesday promising topline results from the AURORA Renal Biopsy Sub-Study. The company said the data further strengthens the overall evidence supporting the long-term safety of LUPKYNIS in Lupus Nephritis or LN patients.

Lupus Nephritis is a serious manifestation of systemic lupus erythematosus or SLE, a chronic and complex autoimmune disease. If poorly controlled, lupus nephritis can lead to permanent and irreversible tissue damage within the kidney.

LUPKYNIS (voclosporin), introduced by the company in January 2021, is a novel agent approved for the treatment of adults with active Lupus Nephritis. LUPKYNIS is the first U.S. FDA- and EC-approved oral medicine for the treatment of adult patients with active Lupus Nephritis.

The company now noted that 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 or eGFR slope over time.

Greg Keenan, recently appointed Chief Medical Officer of Aurinia, said, "We are encouraged by these results. 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."

Further data will be presented at the upcoming Congress of Clinical Rheumatology meeting, May 4-7, 2023.

In pre-market activity on the Nasdaq, Aurinia shares were trading $10.33, up 1.8 percent.

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