The US Food and Drug Administration (FDA) has imposed a clinical hold on Kezar Life Sciences’ investigational new drug application for zetomipzomib, aimed at treating LN.
This decision is in direct response to the company’s voluntary suspension of subject enrolment and dosing in the Phase II PALIZADE clinical trial.
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Kezar suspended the dosing and enrolment based on the recommendation from the trial’s independent data monitoring committee (IDMC), which reviewed the emerging trial safety data.
These findings included an assessment of four grade five (fatal) serious adverse events (SAEs) that occurred during the trial in patients enrolled in the Philippines and Argentina.
The IDMC’s review indicated that three of the fatalities shared a pattern of symptoms and occurred close to the time of dosing.
Additional non-fatal SAEs also displayed a similar timing about dosing. Kezar remains unaware of which patients received zetomipzomib or the placebo.
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By GlobalDataThe FDA has communicated that it will provide Kezar with an official clinical hold letter within 30 days.
A severe complication of systemic lupus erythematosus (SLE), LN affects approximately 50% of SLE patients within ten years of diagnosis.
The disease is characterised by a range of vascular, glomerular and tubulointerstitial lesions and is associated with significant morbidity. Patients with LN are at an increased risk of end-stage renal disease, which may necessitate dialysis or renal transplantation, and have a higher risk of mortality.
Currently, the treatment options for LN are limited. Standard management involves induction therapy to achieve remission, followed by long-term maintenance therapy to prevent relapse.
Kezar Life Sciences CEO Chris Kirk said: “We are steadfastly committed to patient safety and have directed our efforts to investigating these cases as we look to continue the zetomipzomib development programme.
“At this time, our zetomipzomib IND for the treatment of autoimmune hepatitis is unaffected. Our Phase IIa PORTOLA clinical trial of zetomipzomib in patients with autoimmune hepatitis remains active, and we have not observed any grade four or five SAEs in the PORTOLA trial to date.”
