Four Grade 5 SAEs Prompt Suspension of Lupus Nephritis Trial
- Kezar Life Sciences announces clinical hold of zetomipzomib IND for treatment of lupus nephritis
- Four Grade 5 serious adverse events led to the suspension of enrollment and dosing in Phase 2b PALIZADE trial
- FDA to provide official clinical hold letter within 30 days
- Zetomipzomib IND for autoimmune hepatitis unaffected, Phase 2a PORTOLA trial remains active
Kezar Life Sciences has announced that the clinical hold of zetomipzomib IND for treating lupus nephritis following a teleconference with the U.S. Food and Drug Administration (FDA). The decision comes after the company voluntarily suspended enrollment and dosing in its Phase 2b PALIZADE trial at the recommendation of the Independent Data Monitoring Committee (IDMC) due to four Grade 5 serious adverse events (SAEs) that occurred during the study. The FDA will provide an official clinical hold letter within 30 days. However, the IND for autoimmune hepatitis remains unaffected, and the Phase 2a PORTOLA trial continues without any Grade 4 or 5 SAEs. Lupus nephritis is a severe complication of systemic lupus erythematosus affecting around 50% of patients within 10 years of diagnosis. Kezar Life Sciences is a clinical-stage biopharmaceutical company developing novel small molecule therapeutics for immune-mediated diseases.
Factuality Level: 9
Factuality Justification: The article provides accurate and objective information about the clinical hold on zetomipzomib for lupus nephritis treatment, details about the safety concerns, and updates on other ongoing trials. It also includes relevant background information about lupus nephritis and Kezar Life Sciences. The language is mostly neutral and free from sensationalism or personal opinions.
Noise Level: 3
Noise Justification: The article provides relevant and specific information about a clinical hold on an IND application for a drug trial due to safety concerns. It includes details about the issue, its impact on ongoing trials, and the company’s commitment to patient safety. However, it also contains some forward-looking statements and legal disclaimers that may not be directly relevant to the main topic.
Public Companies: Kezar Life Sciences, Inc. (KZR)
Key People: Chris Kirk (Chief Executive Officer)
Financial Relevance: Yes
Financial Markets Impacted: No
Financial Rating Justification: The article discusses a biotechnology company, Kezar Life Sciences, and its decision to suspend enrollment and dosing in a clinical trial due to safety concerns. This impacts the development of their drug zetomipzomib for lupus nephritis treatment. Although there are financial topics mentioned (the company’s stock symbol and reference to potential impact on the development program), it does not directly affect financial markets or specific companies.
Presence Of Extreme Event: No
Nature Of Extreme Event: Other
Impact Rating Of The Extreme Event: Minor
Extreme Rating Justification: The article discusses a clinical hold on the zetomipzomib Investigational New Drug application for lupus nephritis treatment due to safety concerns, but it is not an extreme event as it is related to a specific drug trial and does not have significant impact beyond the company involved.
Move Size: No market move size mentioned.
Sector: Healthcare
Direction: Down
Magnitude: Large
Affected Instruments: Stocks
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