Praxis Precision provides clinical updates at AES annual meeting

Praxis Precision (PRAX) Medicines provided clinical updates shared at the American Epilepsy Society Annual Meeting on December 6, 2025. Relutrigine for Developmental and Epileptic Encephalopathies: At AES, Praxis shared results of the EMBOLD study, demonstrating relutrigine was well-tolerated with rapid, significant and increasing seizure reduction over time with broad functional improvements across behavior, alertness, communication and overall status. Praxis will meet with the FDA in the coming weeks to discuss next steps for the New Drug Application. Praxis will make a determination of the timing for filing the NDA after the meeting. Patients receiving relutrigine experienced a 53% placebo-adjusted reduction in seizures over 16-weeks; Patients achieved a 66% increase in motor seizure-free days; Both clinician and caregiver global impression scores showed statistically significant improvements, with most patients improving across both scales in alertness, communication, and seizure severity. There were no drug-related serious adverse events and treatment-related adverse events were predominantly mild and moderate. Vormatrigine for Focal Onset Seizures and Generalized Epilepsy: RADIANT results position vormatrigine as a best-in-disease therapy: fast-acting efficacy without titration, sustained reduction over longer treatment duration, seizure-freedom potential, favorable DDI, tolerability and safety profiles with once-daily dosing. Focal Onset Seizures. Patients taking vormatrigine for 8 weeks on background anti-seizure medications saw a 54% median reduction in seizures. In week 1, 58% of patients achieved at least a 50% reduction in seizures, which increased to 61% by week 8. Increasing and sustained effect was observed, with FOS patients reaching 100% median weekly seizure reduction after 8 weeks and maintained through 16 weeks. Over 11% of patients experienced seizure freedom for the entire 8-week period and roughly one third of patients experienced seizure freedom for a consecutive 28-day period. Generalized Epilepsy: Three patients with generalized epilepsy included in the cohort experienced a similar treatment effect as FOS patients, with rapid, durable seizure reduction. Praxis has completed recruiting for the POWER1 pivotal study in FOS and is on track to complete the POWER2 study in the second half of 2026. The monotherapy study, POWER3, is on track to begin in the first half 2026.