Last summer, Aurinia $AUPH found itself between a rock and a hard place as it sought to explain a troubling cluster of deaths in the two dosing cohorts — as well as an odd flip-flop in results you might expect to see from the low and high doses — used to test their drug voclosporin for lupus nephritis. Unsatisfied by the case Aurinia made for efficacy and safety at 24 weeks, investors pulled out after looking over the fallout, cratering the stock.
Since then, the stock has managed to retrieve much of what it lost that tumultuous day. And now, Aurinia will try to make a good impression with 48 week data from the Phase IIb study, which posted with even better efficacy data. And this time the company insists it’s ready to step up to a late-stage test to prove it has a drug that can make a difference for patients.
The key data point: After 48 weeks, the low-dose drug group achieved a complete remission rate of 49%, up from 33% at 24 weeks, according to Aurinia. That cohort still managed to do better than the high dose arm, with a 40% CR rate. The control arm hit a mere 24%.
Tracking partial remissions, the low dose hit 68% and 72% in the low and high dose groups, only slightly changed from the 24 week results. The control arm also held steady with a 48% PR rate.
This time, investors seemed happy to accept a success. Aurinia’s shares spiked 65%.
The biotech likely breathed a sigh of relief in assessing serious adverse events, with no new deaths to report in either drug arm and 3 deaths and one malignancy to cite in the control arm. Last summer analysts 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 at the time, where most of the deaths occurred. The deaths were not related to the drug, they said in the earlier call, and might be attributed to the kind of treatment standards in daily practice in Asia. In their statement last August, 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.
As far as the company is concerned now, they’ve answered all the questions they need to set out in a pivotal Phase III trial.
Brad Rovin, director of nephrology and vice chairman of desearch for the Department of Internal Medicine at the Ohio State University Wexner Medical Center, had this to say:
“The AURA trial’s long-term results convincingly demonstrate that the addition of voclosporin to standard-of-care treatment is superior to standard-of-care alone. These data are not only statistically significant, but clinically important. Twice as many patients given 23.7 mg voclosporin twice daily achieved a complete renal response compared to those treated with placebo. This is an impressive renal response rate and these results may shift the treatment paradigm of LN. Based on these encouraging data, I am looking forward to the Phase III trial of voclosporin in LN.”
That Phase III is slated to begin next quarter, regardless of what the analysts say next.
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