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Investing.com -- Kezar Life Sciences Inc (NASDAQ:KZR) stock gained 4% after the FDA lifted a partial clinical hold on its completed Phase 2a trial evaluating zetomipzomib in patients with autoimmune hepatitis (AIH).
The clinical-stage biotechnology company announced that the FDA’s Division of Hepatology and Nutrition removed the hold following a comprehensive safety assessment of the zetomipzomib program. This development allows Kezar to proceed with plans for future clinical trials of the first-in-class selective immunoproteasome inhibitor in AIH patients.
"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, PhD, CEO 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."
While Kezar has suspended development of zetomipzomib for lupus nephritis (LN) to focus on AIH, the company has received recommendations from the Independent (LON:IOG) Data Monitoring Committee for conducting future clinical trials in LN. Based on this feedback and internal safety data analysis, Kezar plans to request that the FDA’s Division of Rheumatology and Transplant Medicine lift the clinical hold on zetomipzomib in LN as well.
Kezar Life Sciences focuses on developing novel small molecule therapeutics for immune-mediated diseases with unmet medical needs.
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