Stoke reports STK-001 data: 85% median seizure reduction at 3 months; FDA allows 70mg dosing

Stoke Therapeutics, Inc.

Phase 1/2a: 70mg (2-3 doses) showed median 85% reduction in convulsive seizure frequency at 3 months (n=10) and 74% at 6 months (n=9) after last dose.
OLE studies: durable seizure reductions and clinically meaningful improvements in cognition/behavior (VINELAND-3) over 12 months with continued 30mg or 45mg dosing.
FDA clearance for three 70mg doses followed by 45mg; company plans to meet with regulators to discuss registrational study design.
STK-001 generally well-tolerated; 30% (24/81) had treatment-related TEAEs, most commonly CSF protein elevation and procedural vomiting.
92% of eligible patients enrolled in OLEs with 84% remaining; data contrast with natural history showing no improvement in seizures or cognition.

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