Aurinia Pharmaceuticals has reported positive interim results from the AURORA 2 continuation study of Lupkynis (voclosporin) to treat lupus nephritis (LN).
The structurally modified calcineurin inhibitor (CNI) Lupkynis is intended to treat adult patients with LN, which is a serious manifestation of systemic lupus erythematosus (SLE).
The randomised, double-blind, placebo-controlled Phase III AURORA 2 clinical trial is evaluating the tolerability and safety of the oral medicine to treat LN in patients with SLE, a complex chronic autoimmune disease.
Participants who have completed a one-year treatment during the Phase III AURORA 1 trial were eligible for enrolment in the AURORA 2 continuation study.
In this study, the LN patients were given 23.7mg voclosporin or placebo in combination with 1g mycophenolate mofetil twice a day for 24 additional months.
According to the interim analysis, around 216 patients continued into the AURORA 2 study and received total treatment for 30 months.
It was observed that the patients in the LN group who received Lupkynis sustained meaningful reductions in proteinuria with a stable estimated glomerular filtration rate (eGFR) at 30 months.
Furthermore, lupkynis showed sustained safety and tolerability compared to placebo.
Aurinia Pharmaceuticals chief medical officer Neil Solomons said: “We are encouraged to see the continued positive outcomes with Lupkynis and look forward to seeing and presenting the complete results from AURORA 2 in the coming months.”
The final results of the AURORA 2 continuation study are anticipated to be released by the end of this year.
In May 2021, Aurinia reported positive results from a Phase III AURORA 1 study of oral therapy Lupkynis in adult patients with LN.