Praxis Halts POWER2 Enrollment After POWER1 Misses Endpoint but 50% Responder Rate at 30 mg
PRAX•Praxis Precision Medicines' Phase 2/3 POWER1 trial of vormatrigine failed its primary endpoint measuring monthly seizure frequency change. The 30 mg arm met the 50% responder rate with stronger seizure reduction in weeks 7–12 and under 10% adverse-event discontinuations; POWER2 enrollment is paused for program reassessment.
1. POWER1 Trial Outcomes
The Phase 2/3 POWER1 study randomized focal-onset seizure patients to once-daily 20 mg of vormatrigine for six weeks then 30 mg for six weeks versus placebo. The trial did not meet its primary endpoint of percentage change in monthly seizure frequency, but the 30 mg arm achieved a 50% responder rate, showed more pronounced seizure reduction in weeks 7–12, and had under 10% discontinuations due to adverse events.
2. Pause of POWER2 Enrollment
In response to POWER1 results, Praxis has paused enrollment in the ongoing POWER2 study to review efficacy and safety data and explore potential modifications to dosing or trial design. Approximately 90% of patients from the active arm have transitioned into, and remain in, an open-label extension.
3. Broader Pipeline Focus
While reassessing vormatrigine development, Praxis is advancing other late-stage programs, including planned launches for relutrigine and ulixacaltamide, leveraging its CNS precision neuroscience platform to prioritize resource allocation and maximize value across its portfolio.
