Stoke Therapeutics Announced Alignment With Global Regulatory Agencies On The Design Of Its Phase 3 EMPEROR Study Of Zorevunersen For Dravet Syndrome, The Study Is Expected To Start In Mid-2025

Following successful interactions with the FDA, EMA and PMDA, 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 <18 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.