Kezar Life Sciences Reports Clinical Hold on Zetomipzomib IND for Lupus Nephritis Treatment

SOUTH SAN FRANCISCO, CA, USA I October 04, 2024 I

Kezar Life Sciences, Inc. (Nasdaq: KZR), a biotechnology company focused on developing small molecule treatments for immune-mediated diseases, announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on its Investigational New Drug (IND) application for zetomipzomib, intended for the treatment of lupus nephritis (LN). This decision follows Kezar's voluntary suspension of patient enrollment and dosing in its Phase 2b PALIZADE clinical trial for active LN, based on recommendations from the trial’s Independent Data Monitoring Committee (IDMC). The IDMC's advice came after a review of safety data, which included four Grade 5 (fatal) serious adverse events (SAEs) among patients in the Philippines and Argentina. The FDA is expected to issue an official clinical hold letter within 30 days.

Kezar’s CEO, Chris Kirk, PhD, emphasized their commitment to patient safety and the ongoing investigation into these cases while continuing the development of zetomipzomib. He noted that their IND application for using zetomipzomib to treat autoimmune hepatitis remains unaffected, with the Phase 2a PORTOLA clinical trial for this condition still active and no Grade 4 or 5 SAEs reported in that study.

About Lupus Nephritis:
Lupus nephritis (LN) is a severe complication of systemic lupus erythematosus (SLE), manifesting through various vascular, glomerular, and tubulointerstitial lesions. It affects approximately 50% of SLE patients within a decade of diagnosis, leading to significant health challenges, including an elevated risk of end-stage renal disease, which may require dialysis or kidney transplantation, and increased mortality. Currently, treatment options for LN are limited, typically involving induction therapy to achieve remission and long-term maintenance therapy to prevent disease relapses.

About Kezar Life Sciences:
Kezar Life Sciences is a biopharmaceutical company in the clinical stages of developing innovative small molecule treatments aimed at meeting the unmet needs in immune-mediated diseases.