The US Food and Drug Administration has placed a clinical hold on Kezar Life Sciences’ mid-stage trial of experimental drug for lupus, after the company said it was reviewing the safety data of zetomipzomib in connection with the deaths of four patients in the Philippines and Argentina.
Reuters reports that Kezar was testing the drug in patients with active lupus nephritis, which causes inflammation and damage in the kidneys due to a form of the immune-related condition lupus.
An independent study committee had recommended pausing the trial when it found that three of the fatalities showed a common pattern of symptoms and that the deaths happened close to the time of dosing, while a non-fatal adverse event also showed a similar proximity to the dosing time.
The company said that a separate mid-stage trial testing zetomipzomib in patients with autoimmune hepatitis remains active and no serious adverse events have been reported so far.
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