Aurinia adds secondary endpoint successes to PhIIb lupus data, tries to downplay deaths

Aurinia Pharmaceuticals ($AUPH) has followed up on topline data from its Phase IIb lupus nephritis trial with the publication of details of the secondary endpoints. The trial of voclosporin hit all of its 24-week secondary endpoints, sending Aurinia’s stock up 18% in premarket trading despite deaths in the treatment arms casting a shadow over the data.

The secondary endpoints looked at the effect of the calcineurin inhibitor voclosporin compared to a control therapy in terms of time to complete and partial remission, the proportion of participants who achieved partial remission and other measures. Both the low and high doses of voclosporin beat the control in time to complete remissions, respectively taking 19.7 and 23.4 weeks while the other cohort failed to generate a figure.

More patients in the voclosporin arms achieved partial remission--70% and 66% compared to 49% in the control group--and took less time to reach this state. With the treatment arms also besting the control group in terms of reducing the urine protein/creatinine ratio (UPCR) and the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score, Aurinia claimed a clean sweep of secondary endpoints to go with the complete remission success it reported for the lower dose last month.

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The success of the lower dose of voclosporin in inducing complete remission meant the study met its primary endpoint in the topline data readout. But that success was overshadowed by deaths in the treatment arm, resulting in Aurinia shares nose-diving by more than 55% on the day investors got a first look at the data. Going into the readout on the secondary endpoints, the stock was still down more than 40% on the days preceding the topline data.

Investors have reacted more favorably to the new results, although the deaths still hang over the data.

Thirteen of the 265 participants in the study died. More worryingly for investors, all bar one of the deaths occurred in the treatment arms. More tellingly for Aurinia, all bar two of the deaths occurred in Asia.

In the topline readout, Aurinia said all the deaths were classed by investigators as being unrelated to the study treatment, but failed to quell investor jitters. Aurinia reconfirmed its stance in the latest release, adding that the deaths are “consistent with complications” of lupus nephritis.

The Canadian drug developer is now advancing toward 48-week data that will show the duration of the complete remissions achieved, while also providing a look at how participants are faring against the other secondary endpoints.

Aurinia has also talked about kicking off a Phase III trial next year, although any activities beyond the near term are dependent on the company gaining access to fresh funding or other financial support. The company closed out the first half of 2016 with $12.1 million in cash.

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