Kezar to terminate mid-stage trial for Lupus treatment
The regulator's decision came after the company paused the study in September to review safety data following the deaths of four patients.
Bengaluru: Kezar Life Sciences said on Thursday it would terminate its mid-stage trial studying its experimental drug in patients with active lupus nephritis and focus on developing the drug for a rare chronic disorder called autoimmune hepatitis.
Earlier this month, the U.S. Food and Drug Administration placed a clinical hold on the trial of the drug, zetomipzomib, studying it in patients with active lupus nephritis, which causes inflammation and damage in the kidneys due to a form of immune-related condition called lupus.
The regulator's decision came after the company paused the study in September to review safety data following the deaths of four patients.
An independent study committee had recommended a pause on the trial after it found that 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 also showed a similar proximity to the dosing time.
Kezar said it would continue its mid-stage trial in patients with autoimmune hepatitis, a disease in which the immune system attacks the liver and causes inflammation and tissue damage, without modification after the review of an independent committee.
Till date, no serious adverse events have been observed in the trial, Kezar said.
Separately, Kezar said its board has rejected Concentra Biosciences' proposal to buy the company's outstanding shares for $1.10 apiece in cash.
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