FDA Lifts Pause On Kezar's Liver Drug Trial—Next Stop Lupus Study
The Division of Hepatology and Nutrition of the U.S. Food and Drug Administration lifted the partial clinical hold on Kezar Life Sciences Inc.‘s (NASDAQ:KZR) completed PORTOLA Phase 2a trial evaluating zetomipzomib in autoimmune hepatitis (AIH).
AIH is a chronic liver disease in which the body’s immune system mistakenly attacks liver cells, leading to inflammation and damage.
“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, CEO and co-founder of Kezar, in a statement on Tuesday.
Although Kezar has suspended the development of zetomipzomib in lupus nephritis to focus on AIH, the company met with the Independent Data Monitoring Committee (IDMC) for the previously terminated PALIZADE clinical trial to review its safety profile.
The IDMC has provided Kezar with recommendations for conducting future clinical trials in lupus nephritis.
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 lupus nephritis.
In October 2024, the FDA placed a clinical hold on the zetomipzomib Investigational New Drug (IND) application for lupus nephritis.
The action followed Kezar's communication to the FDA that Kezar was voluntarily suspending enrollment and dosing in its Phase 2b PALIZADE trial of zetomipzomib in lupus nephritis patients at the recommendation of the trial's independent committee.
The recommendation followed their review of emerging safety data, including an assessment of four Grade 5 (fatal or death) serious adverse events (SAEs) that occurred during the trial in patients enrolled in the Philippines and Argentina.
KZR Price Action: Kezar Life Sciences shares were down 9.09% at $4.20 at the time of publication Wednesday, according to Benzinga Pro.
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