Kezar Life Sciences lifts partial clinical hold on PORTOLA Phase 2a trial

The company states: “Kezar Life Sciences (KZR) announced that the Division of Hepatology and Nutrition of the U.S. Food and Drug Administration has lifted the partial clinical hold on the completed PORTOLA Phase 2a clinical trial evaluating zetomipzomib, a first-in-class selective immunoproteasome inhibitor, in patients with autoimmune hepatitis. Although Kezar has suspended development of zetomipzomib in lupus nephritis to focus on AIH, the company met with the Independent Data Monitoring Committee for the previously terminated PALIZADE clinical trial to review the safety profile of zetomipzomib. The IDMC has provided Kezar with recommendations for conducting future clinical trials in LN. Based on this feedback and internal analysis of safety data across all clinical studies involving zetomipzomib, Kezar plans to respond to the FDA Division of Rheumatology and Transplant Medicine with a request to lift the clinical hold on zetomipzomib in LN.”