Shares of Aurinia Pharmaceuticals Inc. (AUPH Quick QuoteAUPH - Free Report) crashed 55% after the company reported results from a phase IIb study, AURA-LV, on its pipeline candidate, voclosporin, in patients with active lupus nephritis (LN).

The randomized, controlled, double-blind study compared the efficacy of voclosporin in combination with the current standard of care, CellCept (mycophenolate mofetil), with the standard of care plus placebo in achieving complete remission (CR) in patients with active LN. The study assessed two doses of voclosporin while all patients received background therapy of CellCept, along with an aggressive oral corticosteroid taper.

Although the trial achieved its primary endpoint as results showed statistically significantly greater CR in patients treated with 23.7 mg of voclosporin twice daily (p=0.045), a high numbers of deaths came as a major disappointment.

Specifically, results demonstrated the occurrence of 13 deaths across the trial – two in the high-dose voclosporin arm, 10 in the low-dose voclosporin arm and one in the control arm, with the majority of overall deaths (11 out of 13) occurring in Asia. Although the overall rate of adverse events was similar across all groups, that of serious adverse events was higher in both voclosporin groups.

Aurinia intends to meet with the FDA in the fourth quarter of 2016 to discuss these data and the drug’s subsequent clinical development and path to registration in LN. Aurinia plans to submit the results for presentation at a major medical meeting.

AURINIA PHARMA Price

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The mixed results were highly disappointing for this clinical-stage biopharmaceutical company as voclosporin is its lead candidate as they clouded the candidate’s growth trajectory. Note that in Mar 2016, the FDA granted Fast Track designation for voclosporin for the treatment of LN.

Aurinia Pharma currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Pacira Pharmaceuticals, Inc. (PCRX Quick QuotePCRX - Free Report) , Corcept Therapeutics Incorporated (CORT Quick QuoteCORT - Free Report) and ANI Pharmaceuticals, Inc. (ANIP Quick QuoteANIP - Free Report) . All three stocks sport a Zacks Rank #1 (Strong Buy).

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