Drug Development

Facing questions on patient deaths, Aurinia shares crater in wake of lupus study

Aurinia Pharmaceuticals managed to kick up a brief spike in its share price this morning after releasing some upbeat numbers from a Phase IIb study of its lupus drug voclosporin. But it didn’t last long. The shares $AUPH quickly cratered, plunging by 48%, as questions turned to a cluster of deaths tracked in its two dosage arms as well as the cost of the pivotal study needed for an approval.

At first blush, the numbers in the 265-patient study looked solid. The low dose of the drug hit the primary endpoint on complete responses for the lupus patients. But during the followup call, analysts questioned why the low dose would beat out the high dose on CRs. They also zeroed in on 13 deaths recorded in the study – 10 in the low-dose arm, 2 in the high-dose arm and only one in the control group.

Forty percent of all the patients in the study were enrolled in Asia, company execs responded, where most of the deaths occurred. The deaths were not related to the drug, they said in the call, and might be attributed to the kind of treatment standards in daily practice in Asia. In the statement, the company conceded that:

The overall rate of serious adverse events (SAEs) was higher in both voclosporin groups but the nature of SAEs is consistent with highly active LN.

Mary Anne Dooley, the chief investigator for the study, maintained that voclosporin “could potentially change the current treatment paradigm for LN.”

Investigators combined voclosporin to the current standard of care of mycophenolate mofetil, comparing it to a combo using a placebo.

The drug, though, wasn’t always that much better than the placebo/SoC arm. In the study, 32.6% of patients on low dose achieved CR, compared to 27.3% on high dose and 19.3% in the control arm. Leerink’s Joseph Schwartz noted that the deaths will need to be studied more, adding that the positive results also left something to be desired. He added:

“At first glance, the efficacy seen in the drug arms looks lower than what we had expected, but still respectable. The study was 80% powered to detect a remission rate of 41% for the drug versus 20% for placebo based on a planned sample size of 258 subjects. CR rates as low as 35% vs. 15% or as high as 47% versus 25% would also maintain 80% power. The reverse dose response was surprising, particularly since this would have been pulled down by accounting for the relatively high number of deaths in the drug arm.”

The Canadian biotech noted that it had $12.1 million in cash at the end of H1, leaving it looking for fresh funds with a battered stock price.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
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Catalytic Data Science Charleston, SC
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Flatiron Health New York City or San Francisco

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