US-based biopharmaceutical company Kezar Life Sciences has suspended subject enrolment and patient dosing in the Phase II PALIZADE trial of zetomipzomib for active lupus nephritis.
The decision to suspend the trial was made following recommendations from an independent data monitoring committee (IDMC) after it had reviewed safety data from the trial.
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According to the safety findings, four Grade Five (fatal) serious adverse events (SAEs) were reported during the trial in subjects enrolled in Argentina and the Philippines.
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.
The pause in the PALIZADE trial will allow Kezar to thoroughly evaluate the data concerning the SAEs and consider future actions and possible risk mitigation measures.
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By GlobalDataThe company has informed all study investigators and is in the process of notifying regulatory authorities, including the US Food and Drug Administration (FDA) and the European Medicines Agency, about the suspension.
Kezar said there is currently no formal investigational new drug clinical hold in place, adding that if the company receives a clinical hold letter from the FDA, it will review the contents and decide on the necessary steps forward.
Kezar Life Sciences CEO Chris Kirk said: “Our top priority is the safety of every patient who participates in our clinical trials.
“We will continue to work with the site investigators to learn more about each of these cases and hope to have an informed discussion with the IDMC and regulatory authorities as we look to continue the zetomipzomib development programme in lupus nephritis and autoimmune hepatitis.”
In August this year, Kezar announced plans to suspend the development of its Phase I solid tumour drug to focus on zetomipzomib.
