The US Food and Drug Administration (FDA) has placed a second clinical hold on Kezar Life Sciences’ zetomipzomib program in just two months, dealing a significant blow to the company’s efforts to treat lupus nephritis. This decision comes after four patient fatalities and other serious adverse events were reported during the phase 2b trial of zetomipzomib for lupus nephritis.
Zetomipzomib, an investigational therapy, had shown promise in treating lupus nephritis, a serious complication of systemic lupus erythematosus (SLE). However, the Independent Data Monitoring Committee (IDMC) recommended suspending enrollment and dosing in the PALIZADE clinical trial due to emerging safety data. The FDA subsequently placed the clinical hold, citing concerns over the therapy’s safety profile.
Kezar Life Sciences has announced that it will investigate the causes of the adverse events and work to address the FDA’s concerns. The company remains committed to developing zetomipzomib, emphasizing its potential to treat autoimmune diseases. Notably, the FDA’s clinical hold does not affect Kezar’s other zetomipzomib trial for autoimmune hepatitis.
The lupus community is closely watching the developments surrounding zetomipzomib, as current treatment options for lupus nephritis are limited. The FDA’s decision highlights the importance of ensuring patient safety during clinical trials and the need for rigorous testing of new therapies.
In the wake of this setback, Kezar Life Sciences must now navigate the challenges of resolving the clinical hold and restarting its zetomipzomib program. The company’s ability to address the FDA’s concerns and revive its lupus nephritis treatment will be crucial in determining the future of zetomipzomib.
