Sept 30 (Reuters) - Kezar Life Sciences ( KZR ) 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
U.S. 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.