US FDA lifts clinical hold on PORTOLA phase 2a trial of Kezar Life Sciences for evaluating zetomipzomib

US FDA lifts clinical hold on PORTOLA phase 2a trial of Kezar Life Sciences for evaluating zetomipzomib

By, Admin 21 July 2025

Overview

Kezar Life Sciences, Inc, a clinical-stage biotechnology company developing novel small molecule therapeutics to treat unmet needs in immune-mediated diseases, announced that 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 2a clinical trial evaluating zetomipzomib, a first-in-class selective immunoproteasome inhibitor, in patients with autoimmune hepatitis (AIH).

Statement from Chris Kirk: CEO and co-founder of Kezar

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

Kezar Seeks FDA OK to Resume Zetomipzomib Trials in Lupus Nephritis

  • Although Kezar has suspended development of zetomipzomib in lupus nephritis (LN) to focus on autoimmune hepatitis, the company met with the Independent Data Monitoring Committee (IDMC) 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 US FDA Division of Rheumatology and Transplant Medicine with a request to lift the clinical hold on zetomipzomib in lupus nephritis.

About Zetomipzomib

  • Zetomipzomib is a novel, first-in-class, selective immunoproteasome inhibitor with broad therapeutic potential across multiple autoimmune diseases. 
  • Preclinical research demonstrates that selective immunoproteasome inhibition results in a broad anti-inflammatory response in animal models of several autoimmune diseases, while avoiding immunosuppression. 
  • Data generated from completed clinical trials provide evidence that zetomipzomib exhibits a favorable safety and tolerability profile for development in severe, chronic autoimmune diseases.

About the disease: Autoimmune hepatitis

  • Autoimmune hepatitis is a rare chronic disease in which the immune system attacks the liver and causes inflammation and tissue damage, severely impacting patients’ physical health and quality of life. 
  • Lifelong maintenance therapy is required to avoid relapse and burdensome adverse effects. If left untreated, AIH can lead to cirrhosis, liver failure and hepatocellular carcinoma. 
  • In the United States, AIH affects approximately 100,000 individuals, with incidence rates increasing. The cause of this condition remains unclear, with females affected four times as often as males. 
  • Currently, standard of care treatment for AIH is chronic, immunosuppressive treatment with corticosteroids that frequently cause life-altering side effects, including diabetes, osteoporotic fractures and cataracts. 
  • There is a significant need for treatment regimens that reduce or remove the need for chronic immunosuppression from use of corticosteroids.

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