Stoke Therapeutics (STOK) announced alignment with global regulatory agencies on the design of the company’s Phase 3 EMPEROR study of zorevunersen for the treatment of Dravet syndrome. Following interactions with the FDA, European Medicines Agency and Pharmaceuticals and Medical Devices Agency, the company has finalized its EMPEROR Phase 3 study protocol. The proposed study will evaluate two loading doses of 70mg followed by two maintenance doses of 45mg over 52-weeks compared to sham in children and adolescents ages 2 to less than18 with Dravet syndrome. The primary endpoint will be reduction in major motor seizure frequency. Key secondary endpoints will include improvements in cognition and behavior as measured primarily by Vineland-3. The company plans to initiate the Phase 3 study in mid-2025.
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