FDA lifts partial hold on Kezar’s zetomipzomib trial

The Division of Hepatology and Nutrition of the US Food and Drug Administration (FDA) has lifted the partial clinical hold on the completed PORTOLA Phase IIa clinical trial evaluating zetomipzomib, a first-in-class selective immunoproteasome inhibitor, in patients with autoimmune hepatitis (AIH), California, USA-based drug developer Kezar Life Sciences (Nasdaq KZR) announced yesterday.

"We are pleased that the FDA has lifted the partial clinical hold on zetomipzomib in AIH after their review of our comprehensive safety assessment of the zetomipzomib program,” said Chris Kirk, chief executive and co-founder of Kezar. “We continue to believe that zetomipzomib has the potential to positively transform the lives of patients living with AIH. We look forward to engaging with the FDA to align on the design of the next clinical trial of zetomipzomib in AIH,” he added.