Kezar Life Sciences reports PORTOLA trial may proceed, termination of PALIZADE

Kezar Life Sciences announced key clinical development updates. The IDMC overseeing the PORTOLA Phase 2a clinical trial of zetomipzomib in patients with AIH recommended that the trial may proceed without modification following its third scheduled meeting. The IDMC examined safety data from all patients enrolled in the trial, including data from patients who completed the blinded treatment period and continued to the open-label extension portion of the trial which includes an additional 24 weeks of treatment. Three members of the IDMC, including the committee chair, are also members of the IDMC overseeing the PALIZADE study of zetomipzomib in LN. To date, no Grade 4 or 5 serious adverse events, or SAEs, have been observed in the PORTOLA trial which is being conducted at clinical sites in the United States. Kezar has completed enrollment of PORTOLA and plans to report topline data in the first half of 2025. Kezar has also made the strategic decision to terminate the PALIZADE Phase 2b clinical trial in patients with active LN and focus clinical development efforts of zetomipzomib in AIH, a rare disease with a significant unmet medical need. PALIZADE was recently placed on clinical hold following the recommendation of the IDMC after its assessment of four Grade 5 SAEs that occurred in patients enrolled in the Philippines and Argentina. Kezar will unblind the trial and perform a full investigation into all safety events from the study. As of termination, 84 patients were enrolled, and Kezar will report available data from PALIZADE at a later date. Kezar’s unaudited cash position is approximately $148M, including cash, cash equivalents and marketable securities, as of September 30. This cash estimate is a preliminary estimate and based on information currently available to management, and this estimate could change.