Dr. Neil Solomons reports

AURINIA DOSES FIRST PATIENT IN AURORA PHASE 3 CLINICAL TRIAL OF VOCLOSPORIN IN LUPUS NEPHRITIS

Aurinia Pharmaceuticals Inc. has dosed the first patient in Aurora, the company's phase 3 confirmatory clinical trial evaluating voclosporin for the treatment of lupus nephritis (LN), an autoimmune disease caused by lupus that involves extreme inflammation and failure of the kidneys.

"Dosing our first patient today is an important milestone for the company," said Dr. Neil Solomons, MD, chief medical officer of Aurinia. "Our phase 3 trial design is nearly identical to that of our successful phase 2 Aura trial, which demonstrated the potential of voclosporin to increase both speed and rates of remission in patients with active LN. We remain dedicated to advancing this treatment and making a meaningful impact in the lives of patients suffering from LN and those around them."

Aurora is a 52-week global double-blind placebo-controlled study designed to demonstrate that voclosporin added to the current standard of care of mycophenolate mofetil (MMF) can increase overall renal response rates in the presence of extremely low steroids. The primary end point is complete renal response at 52 weeks. This trial will recruit approximately 320 patients and is intended to support full marketing approval of voclosporin for patients with LN across multiple regulatory jurisdictions.

"Lupus nephritis is a devastating disease, which, if not managed, can be life-threatening. There is no approved medication to treat the condition, which mostly affects women in their child-bearing years," said Dr. Mary Anne Dooley, MD, MPH, adjunct professor of medicine at the University of North Carolina School of Medicine and principal investigator for the study. "The Aura phase 2 results showed great promise, and, if replicated in phase 3, voclosporin has the potential to change the current treatment paradigm for LN."

About Aurora

The Aurora study is a 52-week global double-blind placebo-controlled phase 3 study that will compare the efficacy of one dose of voclosporin (23.7 milligrams BID) with placebo when added to current standard of care of mycophenolate mofetil (also known as CellCept) in achieving renal response (formerly referred to as complete remission) in patients with active LN. Both arms will also receive low doses of corticosteroids as part of background therapy after a stringent taper. For further questions on the trial or interest in participating, please see the company's website.

About voclosporin

Voclosporin, an investigational drug, is a novel and potentially best-in-class calcineurin inhibitor with clinical trial data in over 2,200 patients across indications. Voclosporin is an immunosuppressant, with a synergistic and dual mechanism of action that has the potential to improve near- and long-term outcomes in LN when added to standard of care (MMF). By inhibiting calcineurin, voclosporin blocks IL-2 expression and T-cell-mediated immune responses. Voclosporin is made by a modification of a single amino acid of the cyclosporine molecule, which results in a more predictable pharmacokinetic and pharmacodynamic relationship with potential for flat dosing. In addition, voclosporin is more potent than and has an improved metabolic profile versus cyclosporine. The company anticipates that, upon regulatory approval, patent protection for voclosporin will be extended in the United States and certain other major markets, including Europe and Japan, until at least October, 2027, under the Hatch-Waxman Act and comparable laws in other countries.

About lupus nephritis

LN, an inflammation of the kidney caused by systemic lupus erythematosus (SLE), represents a serious progression of SLE. SLE is a chronic, complex and often disabling disorder that affects more than 500,000 people in the United States (mostly women). The disease is highly heterogeneous, affecting a wide range of organs and tissue systems. It is estimated that as many as 60 per cent of all SLE patients have clinical LN requiring treatment. Unlike SLE, LN has a strong surrogate marker, proteinuria, which correlates with meaningful longer-term clinical outcome. In patients with LN, renal damage results in proteinuria and/or hematuria and a decrease in renal function as evidenced by reduced estimated glomerular filtration rate, and increased serum creatinine levels. LN is debilitating and costly, and, if poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney, resulting in end-stage renal disease, thus making LN a serious and potentially life-threatening condition.

About Aurinia Pharmaceuticals Inc.

Aurinia is a clinical-stage biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are suffering from serious diseases with a high unmet medical need. The company is currently developing voclosporin, an investigational drug, for the treatment of LN. The company is headquartered in Victoria, B.C., and focuses its development efforts globally.

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