The US Food and Drug Administration (FDA) has released a hold blocking a Phase I/IIa clinical trial testing an increased dose of STK-001, Stoke Therapeutics’ drug candidate for Dravet syndrome. Dravet syndrome is a rare form of severe childhood epilepsy that comes with a short life expectancy and developmental delays.
According to Paul Schloesser, “Stoke spokesperson Dawn Kalmar tells Endpoints News the hold dates back to March 2020 when the company first got clearance to start Phase I/II studies testing candidate STK-001 in Dravet syndrome patients. The decision to put the partial hold in place was based on preclinical data, Kalmar added.”
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(Source: Endpoints News, March 15th, 2023)