Clinical Hold on Kezar Life Sciences’ Lupus Drug Trial

(Reuters) – The U.S. Food and Drug Administration has placed a clinical hold on Kezar Life Sciences (NASDAQ:KZR)’ trial of an experimental drug for lupus, the company announced on Friday.

The FDA’s decision follows the company’s pause of the mid-stage trial for the drug, zetomipzomib, to review safety data after the deaths of four patients involved in the trial in the Philippines and Argentina.

Kezar was testing the drug in patients suffering from active lupus nephritis, a condition that causes inflammation and damage in the kidneys due to a type of immune-related disorder known as lupus.

An independent study committee had recommended suspending the trial after discovering that three of the fatalities exhibited a common pattern of symptoms, with the deaths occurring close to dosing times. A non-fatal adverse event also showed a similar proximity to dosing.

Despite this, the company confirmed that a separate mid-stage trial for zetomipzomib in patients with autoimmune hepatitis remains active, and no serious adverse events have been reported thus far.