While systemic lupus erythematosus (SLE) can affect multiple major organ systems in the body, one of its most severe manifestations is renal (kidney) involvement, known as lupus nephritis (LN). Credit: SciePro via Shutterstock.

Clinical stage biopharma company Kezar Life Sciences is discontinuing its LN clinical programme following the death of four patients.

In discontinuing the programme, the company has terminated the Phase IIb PALIZADE study (NCT05781750). On 30 September, the San Francisco-based company announced it was placing a clinical hold on the PALIZADE trial after four deaths upon a recommendation from the Independent Data Monitoring Committee (IDMC). The trial evaluated its lead autoimmune disease drug zetomipzomib (KZR-616) in patients with LN.

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The PALIZADE trial was initiated after Kezar’s Phase IIa MISSION trial (NCT03393013) demonstrated the potential of zetomipzomib to meaningfully reduce proteinuria and reduce extra-renal manifestations of systemic lupus in patients with LN.

LN is a serious inflammation of the kidneys caused by SLE, the most common form of lupus. It can lead to end-stage kidney disease, requiring dialysis or a kidney transplant.

The company’s stock price fell by 8.8% to $0.81 at market close after the trial’s termination was announced on 17 October.

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Kezar CEO Chris Kirk said: “While we are disappointed to discontinue our development programme in LN, we would like to thank the investigators, patients, and their families for their participation in the PALIZADE trial.”

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A total of 84 patients were enrolled in the PALIZADE trial, with Kezar stating it would unblind the trial and perform a full investigation into all safety events from the study and report available trial data at a later date.

The company added that it now plans to focus its clinical development efforts of zetomipzomib in autoimmune hepatitis (AIH).

Kezar’s PORTOLA Phase IIa trial (NCT05569759) is currently evaluating zetomipzomib in AIH patients. Following the company’s third scheduled meeting with the IDMC, the committee has recommended that the trial may proceed without modification.

During its assessment, 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. No Grade 4 or 5 serious adverse events (SAEs) have been observed in the PORTOLA trial, which is being conducted at clinical sites in the US.

Kezar has completed enrolment of PORTOLA and plans to report topline data from the trial in the first half of 2025.

In 2020, GSK’s BENLYSTA (belimumab) became the first drug approved by the US Food and Drug Administration (FDA) for adult patients with active LN.