Trial data showed that Lupkynis (voclosporin) plus standard of care (SoC) of mycophenolate mofetil (MMF) and low-dose corticosteroids offered statistically superior complete renal response (CR) rates versus SoC alone at 52 weeks.
Lupkynis is an oral therapy indicated for treating active LN while MMF and corticosteroids are SoC immunosuppressive agents used to treat the disease.
In January this year, the US Food and Drug Administration (FDA) granted approval to Lupkynis plus a background immunosuppressive therapy regimen for active LN patients.
The global, randomised, double-blind, placebo-controlled Phase III AURORA 1 study enrolled 357 subjects. It analysed the efficacy and safety of Lupkynis 23.7mg twice daily along with SoC versus SOC alone in an ethnically and racially diverse population of active LN patients.
The study data showed a statistically superior complete renal response rates of 41% with Lupkynis as against 23% with the control, thereby meeting its primary endpoint.
Lupkynis also showed statistical significance in all pre-specified hierarchical secondary endpoints such as improved time to 50% decrease from baseline in Urinary Protein Excretion Estimation (UPCR) or and time to UPCR less than 0.5mg/mg versus control.
The treatment was found to be well tolerated and no unexpected safety signals were noted.
Furthermore, serious adverse events were observed in 21% of Lupknyis treated patients versus 21% in the control arm.
Aurinia Pharmaceuticals Research executive vice-president Robert Huizinga said: “It is the culmination of many years of research both within Aurinia and with investigators and patients and we look forward to continuing our research with this important compound, and to sharing longer-term safety and efficacy data from the ongoing AURORA 2 continuation study in the coming months.”
In October last year, Aurinia initiated an open-label exploratory trial to analyse the antiviral effects of voclosporin in kidney transplant recipients (KTRs) with Covid-19.