Aurinia Pharmaceuticals announced plans to expand its voclosoprin renal franchise to include focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD). Additionally, Aurinia announced plans to evaluate its proprietary nanomicellar voclosporin ophthalmic solution (VOS) for the treatment of keratoconjunctivitis sicca or dry eye syndrome (DES). The advancement of these new indications, in addition to lupus nephritis (LN), represents an expansion of the company’s strategy, pipeline, and commercial opportunities.
A phase 2 proof of concept clinical trial for voclosporin in FSGS and MCD patients will be initiated in the first half of 2018. FSGS and MCD affect nearly 150,000 patients globally, accounting for almost 50% of patients with Nephrotic Syndrome (NS). The prevalence of FSGS and MCD is increasing through improved diagnosis, and it has been shown that the control of proteinuria is important for long-term survival of these patients. Interim data readouts are anticipated in the second half of 2018.
Aurinia also plans to begin a phase 2a tolerability study of VOS versus the standard of care for the treatment of DES by the second quarter of 2018, with data available in the second half of 2018. Calcineurin inhibitors are a mainstay in the treatment for DES, and the goal of this program is to develop a best-in-class treatment option.
Aurinia’s phase 3 clinical study (AURORA) for the treatment of LN is on track to complete enrollment in the second half of 2018, with 113 clinical trial sites active around the globe. Additionally, under voclosporin’s fast-track designation, Aurinia intends to utilize a rolling new drug application (NDA) process, with the first module being submitted in the second half of 2018.
“Our clinical data in LN demonstrated that voclosporin profoundly decreased proteinuria, which is also an important disease marker for FSGS and MCD. Furthermore, voclosporin appears to demonstrate a more predictable pharmacology and an improved lipid and metabolic profile over legacy calcineurin inhibitors, which have shown efficacy in treating autoimmune disorders similar to those we are targeting,” Neil Solomons, MD, Chief Medical Officer of Aurinia Pharmaceuticals, said in a company news release. “The topical formulation, VOS, has shown evidence of efficacy in our partnered canine studies and in a human Phase I study, supporting its development in DES.”
“With the AURORA trial in LN now well underway, we’re poised to enter the next phase of development for Aurinia. By leveraging our expertise and the unique profile of voclosporin to pursue these novel indications, we hope to bring new treatment options to patients where significant unmet medical need remains,” said Richard Glickman, LLD, CEO and Chairman of Aurinia Pharmaceuticals. “Furthermore, we believe our pipeline expansion has the potential to create significant value for shareholders.”
Aurinia believes its current financial resources are sufficient to fund all existing programs, the announced new programs, and operations into 2020.
R&D Day webcast
Members of the Aurinia leadership team and external key opinion leaders will provide insights for voclosporin in LN and the new indications at an R&D Day, being held today at 8:30 a.m. Eastern Time in New York, NY and via webcast at http://ir.auriniapharma.com/ir-calendar.