KEZAR Life Sciences said on Monday it has paused a trial of its experimental drug for lupus to review safety data after four patients died in the mid-stage study.
The San Francisco-based company said it had informed the US Food and Drug Administration and European regulators of the decision to pause enrollment and dosing in the trial.
An independent study committee had recommended the pause after reviewing safety data, following the deaths of patients enrolled in trials in the Philippines and Argentina.
Review of the data by the committee showed three of the fatalities showed a common pattern of symptoms and the deaths happened close to the time of dosing, while a non-fatal adverse event showed a similar proximity to dosing, the company said.
Kezar was testing the treatment, zetomipzomib, in patients with active lupus nephritis, a type of kidney disease caused by lupus — where the body’s immune system attacks its own cells and organs.
To date, 84 patients have been enrolled in the mid-stage trial, according to Kezar.
The company said it has not observed any instances of death or serious infections in prior clinical studies of zetomipzomib.
Another mid-stage trail testing zetomipzomib in patients with autoimmune hepatitis, remains active with no serious adverse events observed to date, the drug developer said. — Reuters
