Aurinia's Stock More Than Doubles On Results From Pivotal Trial Of Voclosporin In Lupus Nephritis

Shares of small-cap biotech Aurinia Pharmaceuticals Inc AUPH are on a tear after the company reported positive clinical readout for its lead asset voclosporin in treating lupus nephritis, an autoimmune disorder.

Aurinia has a single-product pipeline. Voclosporin is being evaluated for multiple indications. The investigational asset is in the most advanced stage of clinical development for lupus nephritis.

Strong Efficacy And No Safety Scare

The company announced positive safety and efficacy data from its pivotal Phase 3 study of voclosporin, in combination with mycophenolate, the current standard of care, and low-dose corticosteroids in the treatment of lupus nephritis.

The global study that evaluated 357 patients with active lupus nephritis met its primary endpoint of renal response rates of 40.8% for voclosporin compared to 22.5% for the control arm. The control arm was administered mycophenolate and placebo along with low-dose corticosteroids.

The study also met all pre-specified hierarchical secondary endpoints, which included renal response at 24 weeks, partial renal response at 24 and 52 weeks, time to achieve urinary protein-to-creatinine ratio less than or equal to 0.5 and time to 50% reduction in UPCR.

Aurinia also noted volcosporin was well tolerated with no unexpected safety signals. More importantly, the voclosporin arm showed no significant decrease at week 52 in estimated glomerular filtration rate or increase in blood pressure, lipids or glucose – the common adverse events associated with legacy calcineurin inhibitors.

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A Dire Unmet Need

The treatment of lupus nephritis, which is inflammation of kidney caused by systemic lupus erythematosus, is extremely challenging. It often leads to renal damage, resulting in proteinuria and/or hematuria and a decrease in renal function, as reflected by reduced eGFR, and increased serum creatinine levels. In extreme cases it would lead to end-stage renal disease, a life threatening condition.

"Voclosporin is the first novel treatment that has demonstrated therapeutic efficacy for people living with lupus nephritis and today marks an important advance in the treatment of this potentially life-threatening disease," said Stevan Gibson, CEO of Lupus Foundation of America.

Aurinia said it plans an NDA submission during the first half of 2020.

"We are aware of the intense need for a clinically impactful therapy for this serious disease and are working with urgency to complete regulatory filings in the U.S. and worldwide. If approved, we look forward to potentially making voclosporin available to patients beginning in 2021," said Peter Greenleaf, CEO of Aurinia.

Aurinia shares were ripping higher by 104.41% to $17.15 at time of publication.