We are pleased to share with you breaking research news from Aurinia Pharmaceuticals Inc. announcing that their Phase III trial of voclosporin has met all primary and secondary endpoints with a clean safety profile. Please see our statement below for more information.

Today, Aurinia Pharmaceuticals Inc. announced very positive top-line results of a Phase III clinical study of voclosporin, a potential new treatment for active lupus nephritis (lupus-related kidney disease). The study met all of its primary and secondary endpoints of achieving complete remission in a statistically significant number of study participants who received voclosporin in combination with standard of care. More details about this study are available through the company's news release.

Stevan W. Gibson, President and Chief Executive Officer of the Lupus Foundation of America, said the trial results are significant progress for people living with lupus.

“The positive results for the AURORA Phase III study of voclosporin is the news the lupus community has been waiting for and represents a remarkable breakthrough in efforts to bring a better quality of life for the more than five million people worldwide living with lupus. The data will be equally well received by their doctors who are eager to have more tolerable and targeted treatment options for their patients. The safety profile demonstrated in the AURORA trial shows that doctors may soon have an effective treatment for lupus nephritis that does not require large doses of steroids.

“Kidney disease is one of the most serious and potentially life-threatening complications of lupus. It affects 60 percent of adults and as many as two-thirds of all children with lupus. Should voclosporin be approved by the U.S. Food and Drug Administration (FDA), it would become the first-ever therapy specifically for lupus-related kidney disease.

“The Lupus Foundation of America is proud of its longstanding partnership with Aurinia Pharmaceuticals. Because of our shared vision and mission, we have worked closely since the beginning of their journey to develop voclosporin as the first treatment specifically for lupus nephritis, including educating people with lupus about the trial and the importance of clinical trial participation.

"The Foundation was the first lupus organization to commit support for industry efforts to develop new treatments for lupus nephritis. Within recent years, the Foundation has provided lupus investigators over $1.2 million in funding, across 14 different research studies in nine states at 12 institutions. Additionally, thanks to our public policy initiatives, another $1.2 million were provided by the U.S. Department of Defense Medical Research Program to support research related to lupus nephritis. We continue to advocate to expand research funding for lupus by working with patients, investigators, and government agencies to drive research forward.

“We also are very encouraged that additional potential new therapies remain in the near-term drug development pipeline. Because each case of lupus is unique, a full range of treatment options must be made available to people with lupus. At present, only one therapy explicitly developed for lupus has received regulatory approval. The data from the voclosporin trial suggests an additional option could soon become available.

Aurinia Pharmaceuticals Inc. plans to submit their new drug application (NDA) to the FDA by June 2020, and they hope to receive drug approval by early 2021. We will continue to monitor developments and communicate information to our constituents as it becomes available. Subscribe to Inside Lupus Research and receive bi-weekly updates on breaking news about lupus research.