13 deaths in Aurinia’s lupus drug trial despite hitting Phase II target
pharmafile | August 16, 2016 | News story | Manufacturing and Production, Research and Development | Aurinia, Phase II, biotech, patient deaths, voclosporin
Canadian biotech Aurinia Pharmaceuticals has announced the topline Phase IIb trial results of its lupus nephritis (LN) treatment voclosporin, which revealed it had hit its primary endpoint, but this success was marred by the deaths of 13 trial participants.
LN, or lupus kidney disease is one of the one of the most potentially lethal iterations of the autoimmune illness, affecting as many as 60% of people with lupus. The drug works as a calcineurin inhibitor and as an immunosuppressant. By inhibiting calcineurin, voclosporin blocks IL-2 expression and T-cell mediated immune responses.
The trial studied the effects of voclosporin in addition to Roche’s organ rejection drug CellCept against a combination of placebo and CellCept. According to the company, patients treated with voclosporin twice a day showed significantly greater complete remission over 24 weeks of treatment, twice as likely overall to achieve remission than with placebo.
But the company’s stocks has taken a nosedive by 50% due to the deaths of 12 participants; the company is adamant that these deaths were due to the severe nature of the disease and not the effects of ther drug itself.
An analyst at Leerink noted: “While this does naturally raise questions, it is important to be mindful that these lupus nephritis patients were extremely sick and treated at many sites with differing practice patterns in Asia, some of which we believe were in much less developed places,” Leerink said in a note to clients.
“The company noted that there were no clear underlying patterns among the deaths, and that one patient (who achieved complete remission) for example had baseline proteinurea of 29 grams, which was the highest value they have ever seen in their entire career of treating lupus patients.”
Leerink also noted that it was “incrementally more comfortable that the FDA will view the risk/benefit of voclosporin favourably.”
Matt Fellows
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