FDA partially lifts dosing hold on Stoke Therapeutics' pediatric Dravet syndrome study
RNA player Stoke Therapeutics said Wednesday that the FDA partially lifted a clinical hold on a Phase I/IIa study in children and adolescents with Dravet syndrome, allowing the company to increase the tested dose of its lead drug.
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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