According to Business Wire, a pharmaceutical company, Aurinia Pharmaceuticals Inc., recently announced that they have enrolled the first lupus nephritis patients in the AURORA 2 extension study. Not only this, but Aurinia Pharmaceuticals has also initiated a Phase II trial in patients with focal segmental glomerulosclerosis (FSGS).
What is lupus nephritis?
Lupus nephritis is a type of kidney inflammation that is a result of a complication called lupus. Lupus is an autoimmune disease where your body produces proteins that attack your own body. In lupus nephritis specifically, lupus affects the kidney, which leads to inflammation, hematuria, proteinuria, high blood pressure, and sometimes kidney failure. Some initial symptoms of lupus nephritis include joint pain or swelling, muscle pain, uncaused fever, or a red rash. Treatments for lupus nephritis are geared towards suppressing the the immune system to reduce kidney inflammation. To read more about the condition, click here.
Patients with lupus nephritis have continued to the AURORA 2 extension study after undergoing the Phase III trial. The study is assessing the tolerability and effectiveness of the treatment voclosporin in those who have lupus nephritis.
Focal segmental glomerulosclerosis trial
Another study involving voclosporin is a Phase II study for treatment of focal segmental glomerulosclerosis and has recently begun. Focal segmental glomerulosclerosis, FSGS, is another kidney disease that causes nephrotic syndrome. To read more about FSGS, click here.
The fact that there is a Phase II study involving FSGS patients is big news, as there is no current FDA/EMA approved therapy for the condition. The Phase II study will focus on analyzing the tolerability and safety of voclosporin as a treatment for focal segmental glomerulosclerosis. The endpoint for the study will be complete or partial remission at the 6 month mark.
A positive direction
The potential effectiveness of voclosporin as a treatment option for both kidney-related conditions lupus nephritis and FSGS could be a breakthrough discovery. Those involved in the study are optimistic about the direction it’s headed.
“The AURORA Phase III clinical trial is progressing very well, and full enrollment is anticipated to complete on time. Having the first lupus nephritis patients complete AURORA and roll over into the AURORA 2 extension study reinforces our confidence in the program. This achievement, coupled with initiating trials on new indications, represents a significant milestone for the company,” said Aurinia Pharmaceutical CEO, Richard Glickman.
Chief Medical Officer, Neil Solomons, has more encouraging words to say about the trials.
“Our clinical program for voclosporin has generated substantial data, which serves as the basis for the pursuit of additional indications where there is a high unmet medical need,” he said. “We intend to complete the DES trial before the end of 2018 and look forward to sharing ongoing data readouts for FSGS over the course of 2019.”
Needless to say, these are some pretty cool advancements to keep an eye on. To read more about the studies, click here.