Aurinia Plans FDA Filing After Lupus Nephritis Drug Hits Phase 3 Goals

Xconomy National — 

Aurinia shares spiked last week after voclosporin, an immunosuppressant being tested in patients with lupus nephritis, met its primary and secondary endpoints in a Phase 3 study.

Aurinia Pharmaceuticals (NASDAQ: AUPH) is testing its drug, voclosporin, as a treatment for lupus nephritis (LN), which can occur when lupus, an autoimmune disorder,  causes the immune system to attack the kidneys. While immunosuppressants have been used to treat LN, the Aurinia drug could become the first medicine specifically approved for the condition.

The Lupus Foundation of America estimates that there are 16,000 new cases of lupus per year. Nearly 1.5 million Americans and upwards of five million people worldwide have a form of lupus. Lupus patients who develop LN can progress to end-stage renal disease, at which point patients may need a kidney transplant.

Aurinia’s Phase 3 study, called AURORA, enrolled 357 patients with active LN. The global study tested voclosporin—fast-tracked by the FDA in 2016—in combination with mycophenolate and low-dose corticosteroids.

Versus the standard of care, voclosporin demonstrated “statistically superior” renal response rates and a comparable safety profile. The investigational drug was well tolerated with no unexpected safety signals, according to the company, which plans to file a new drug application in the first half of 2020. If the application is approved, voclosporin could be available to patients beginning in 2021, the company’s president and CEO Peter Greenleaf said in a statement.

After announcing the Phase 3 data late last week, Aurinia shares spiked 84 percent to $15.44. The company today announced a public offering of common shares and is currently trading at roughly the same price.

Greenleaf during the company’s third-quarter earnings call last month said positive results would “trigger a flurry of corporate activities and a company-wide focus on preparing for an NDA submission during the first half of next year.”

If given the OK from regulators, Aurinia expects voclosporin’s patent protection will be extended until October 2027 in the US and other markets, including Europe and Japan. If the FDA decides to include AURORA’s dosing protocol—for which a patent has been issued—the IP protection could be extended until December 2037.

Aurinia also plans to advance voclosporin in other inflammatory and autoimmune conditions, including segmental glomerulosclerosis and dry eye syndrome.

There are others developing treatments for lupus and its complications. Earlier this year, La Jolla, CA-based biotech Equillium (NASDAQ: EQ)  announced plans to initiate a proof-of-concept trial for its EQ001 as potential LN treatment. EQ001 targets a receptor called CD6 that modulates the activity of T-effector cells, according to the company, which in October 2018 raised about $65 million in an initial public offering, 19 months after its founding.

Biogen (NASDAQ: BIIB) also earlier this month announced positive Phase 2 study results for its investigational drug, BIIB059, targeting two types of lupus: Cutaneous Lupus Erythematosus and Systemic Lupus Erythematosus.

(Photo by Robina Weermeijer on Unsplash)