Kezar Life Sciences suspends enrollment of PALIZADE trial

Kezar Life Sciences announced the voluntary cessation in enrollment of new patients and dosing of ongoing patients in the Phase 2b PALIZADE clinical trial, pending further evaluation. PALIZADE is a global, placebo-controlled, randomized, double-blind Phase 2b clinical trial evaluating the efficacy and safety of two dose levels of zetomipzomib in patients with active lupus nephritis, or LN. Patients in the trial are randomly assigned to receive 30 mg of zetomipzomib, 60 mg of zetomipzomib or placebo subcutaneously once weekly for 52 weeks, in addition to standard background therapy. To date, 84 patients have been enrolled in the PALIZADE trial, and patient safety data are reviewed by an Independent Data Monitoring Committee, or IDMC. Kezar has suspended enrollment and dosing in PALIZADE at the recommendation of the IDMC after their recent review of emerging safety data, including an assessment of four Grade 5 serious adverse events that have occurred during the course of the trial in patients enrolled in the Philippines and Argentina. Review of the data by the IDMC revealed that three of the fatalities showed a common pattern of symptoms and proximity to dosing, and additional non-fatal SAEs showed a similar proximity to dosing. Kezar remains blinded as to which patients were on the zetomipzomib or placebo treatment arms. Kezar has not observed any instances of death or serious opportunistic infections in prior clinical studies of zetomipzomib. Kezar’s ongoing Phase 2a PORTOLA clinical trial of zetomipzomib in patients with autoimmune hepatitis has completed enrollment and remains active at this time. To date, no Grade 4 or 5 SAEs have been observed in the PORTOLA clinical trial. Kezar’s decision to pause enrollment and dosing on PALIZADE enables time to evaluate the totality of data regarding the SAEs and determine next steps and potential risk mitigation strategies. The company has notified all study investigators and is notifying regulatory authorities, including the FDA and the European Medicines Agency, of its decision. At this time, a formal Investigational New Drug clinical hold has not been issued. If Kezar receives a clinical hold letter from the FDA, it will review the content and determine next steps.