Overview
- Praxis announced on June 1 that the POWER1 Phase 2/3 trial failed to meet its primary endpoint of percent change in monthly seizure frequency.
- The study met a key secondary measure with a higher proportion of patients achieving at least a 50% reduction in seizures.
- Seizure reductions were stronger in the second half of the trial when patients received the higher 30 mg daily dose, suggesting a dose-response signal that Praxis will analyze further.
- Vormatrigine showed a favorable tolerability profile with adverse-event discontinuations under 10% and roughly 90% of patients from the active arm entering the open-label extension.
- The market reacted negatively with shares falling more than 12% in extended trading and analysts called the decision to pause POWER2 prudent while the company considers trial modifications and next steps.