Clinical TrialJun 1, 2026, 04:28 PM
Praxis Precision Medicines' POWER1 Study Fails Primary Endpoint
AI Summary
Praxis Precision Medicines announced that its Phase 2/3 POWER1 study evaluating vormatrigine for focal onset seizures (FOS) did not meet its primary success measure. While the primary endpoint was missed, the study did meet its secondary measure of a 50% response rate, and higher doses showed more pronounced seizure reduction. The drug was generally well-tolerated, with less than 10% discontinuations due to adverse events, and approximately 90% of patients moved to an open-label extension. Consequently, the company is pausing enrollment in the POWER2 study to reassess the vormatrigine program.
Key Highlights
- Praxis Precision Medicines' Phase 2/3 POWER1 study for vormatrigine in focal onset seizures did not meet its primary success measure.
- The secondary measure, the 50% response rate, was met.
- Seizure reduction was more pronounced on higher dose (30 mg) during the second half of the study.
- Vormatrigine was generally well-tolerated, with adverse event-related discontinuations less than 10%.
- Approximately 90% of patients from the vormatrigine arm transitioned to the open-label extension study.
- The company is pausing enrollment in the POWER2 study to reassess the vormatrigine program.
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