Kezar Life Sciences Suspends Enrollment and Dosing in Phase 2b PALIZADE Trial Due to Safety Concerns

Trial Suspension:
Kezar Life Sciences has voluntarily ceased enrollment and dosing in its Phase 2b PALIZADE trial of zetomipzomib for active lupus nephritis patients due to serious safety concerns.

Safety Concerns:
The decision follows the recommendation of the Independent Data Monitoring Committee (IDMC) after reviewing emerging safety data, including four Grade 5 (fatal) serious adverse events (SAEs) in patients from the Philippines and Argentina.

Fatalities Pattern:
Three of the fatalities showed a common pattern of symptoms and proximity to dosing, while other non-fatal SAEs also demonstrated a similar timing correlation.

Current Enrollment:
84 patients have been enrolled in the PALIZADE trial, and patient safety data are reviewed by the IDMC.

Regulatory Notification:
Kezar has notified all study investigators and is notifying regulatory authorities, including the FDA and the European Medicines Agency.

Company Statement:
Kezar's CEO, Chris Kirk, emphasized the company's primary concern for patient safety and its commitment to collaborating with site investigators and regulatory agencies to gather more insights and determine next steps.

Other Trials:
Kezar is also conducting a Phase 2a PORTOLA clinical trial involving zetomipzomib in patients with autoimmune hepatitis, which has successfully completed enrollment and remains active without any Grade 4 or 5 SAEs reported.