Gene therapy maker reports patient death, halts trial

A child enrolled in Capside Biotherapeutics’ gene therapy trial for STXBP1 developmental and epileptic encephalopathy has died, prompting the company to pause the study while investigating the death. 

The patient was the first participant in the clinical trial. Capside said it is working to determine what happened and has notified the FDA, according to a Sept. 10 letter. 

In the meantime, the clinical trial has been voluntarily paused, and the company will assess next steps for the program once more information becomes available. 

STXBP1-related disorders are rare neurodevelopmental conditions associated with seizures and significant developmental delays. 

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