Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology firm focused on developing innovative small molecules for immune-mediated diseases, has announced that its Investigational New Drug (IND) application for zetomipzomib, aimed at treating lupus nephritis (LN), has been placed on clinical hold by the U.S. Food and Drug Administration (FDA). This decision follows Kezar’s voluntary suspension of enrollment and dosing in the Phase 2b PALIZADE clinical trial, as recommended by the trial’s Independent Data Monitoring Committee (IDMC). The IDMC’s recommendation came after reviewing emerging safety data, which included four Grade 5 (fatal) serious adverse events (SAEs) reported in patients from the Philippines and Argentina. The FDA is expected to send an official clinical hold letter to Kezar within 30 days.
“We remain deeply committed to patient safety and are actively investigating these cases as we proceed with the zetomipzomib development program,” said Chris Kirk, PhD, CEO of Kezar. “Currently, our IND for zetomipzomib in treating autoimmune hepatitis remains unaffected. The Phase 2a PORTOLA clinical trial in patients with autoimmune hepatitis is ongoing, and we have not reported any Grade 4 or 5 serious adverse events in this trial so far.”
About Lupus Nephritis
Lupus nephritis (LN) is a serious complication of systemic lupus erythematosus (SLE), affecting nearly 50% of SLE patients within a decade of diagnosis. LN involves a range of vascular, glomerular, and tubulointerstitial lesions and is associated with significant morbidity, including a heightened risk of end-stage renal disease that may necessitate dialysis or kidney transplantation, as well as an increased risk of mortality. Treatment options for LN are limited, typically involving induction therapy to achieve remission and long-term maintenance therapy to prevent relapse.
