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Trial Of Kezar’s Only Active Drug Halted After Five Patients Die

 
• By Elizabeth Cairns

The FDA has placed zetomipzomib on clinical hold a year after Kezar decided to focus solely on the product.    

A man shows a thumb down. Gesture of disapproval and rejection. Bad assessment, harsh criticism, failure and defeat. Refusal to pass and cooperation. Bureaucratic obstacles. Contempt and condemnation

Retooling a company to focus on a single asset is a high-risk strategy, and one that is generally taken when few other choices present themselves. Having taken this step last year, Kezar Life Sciences, Inc. is almost totally dependent on zetomipzomib reaching a successful Phase IIb readout in lupus nephritis – but this is now in doubt following the deaths of five trial subjects.

Key Takeaways
  • The US FDA has placed the IND for zetomipzomib on clinical hold a few days after Kezar stopped dosing and recruiting new patients in its Phase II lupus nephritis trial.
  • A year ago the company reorganized to focus solely on this asset

The company admitted after market close on 4 October that the US Food and Drug Administration had placed the IND for zetomipzomib on clinical hold

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