Aurina Announces Plans for Single Phase III Clinical Trial for Voclosporin
Aurinia Pharmaceuticals has announced its plans for a single Phase III clinical trial for voclosporin in the treatment of lupus nephritis (LN). This follows the successful completion of end of Phase II meeting with the Food and Drug Administration (FDA). The new trial is expected to commence in 2017.
In the release, Aurinia's CEO Charles Rowland stated, “We are thrilled with the outcome and direction received from the FDA. With a clear path forward for voclosporin’s development to treat LN, we are mobilizing quickly to initiate the Phase III study in Q2 next year, fulfilling our goal of improving the long-term outcomes for patients with this disease."
The Phase III trial will be a global 52-week double-blind, placebo controlled study of approximately 320 patients, according to the release. Aurinia is finalizing the study protocol and regulatory submissions and in parallel is working on site selection.
The full press release can be found here.