newsfilter
← Latest News
GlobeNewswire·

Praxis AES Wrap-up: Best-in-Class Potential Across Rare Pediatric and Adult Epilepsies

PRAX
  • Praxis Precision Medicines presented clinical updates at the American Epilepsy Society Annual Meeting on December 6, 2025, highlighting positive results for relutrigine & vormatrigine.
  • The EMBOLD study for relutrigine showed a 53% placebo-adjusted reduction in seizures (p < 0.0002) & a 66% increase in motor seizure-free days (p = 0.0340) over 16 weeks.
  • Relutrigine recipients in the EMBOLD study demonstrated broad functional improvements in behavior, alertness, communication, & overall status with no drug-related serious adverse events.
  • Praxis plans to meet with the FDA in the coming weeks to discuss next steps for the New Drug Application (NDA) for relutrigine in developmental & epileptic encephalopathies (DEEs).
  • The RADIANT study for vormatrigine showed rapid, consistent, & durable seizure reduction, with 100% of focal onset seizure patients continuing through 16 weeks achieving median weekly seizure reduction.
  • Vormatrigine patients with focal onset seizures achieved a 54% median seizure reduction after 8 weeks, with over 11% experiencing seizure freedom for the entire 8-week period.
  • Three patients with generalized epilepsy in the RADIANT study experienced rapid & durable seizure reduction similar to those with focal onset seizures.
  • Praxis has completed recruiting for the POWER1 pivotal study in focal onset seizures & is on track to complete POWER2 in the second half of 2026.
  • The POWER3 monotherapy study for vormatrigine is on track to begin in the first half of 2026.
  • Praxis expanded the Praxis Analysis of Concordance Framework to include DEEs & showcased its comprehensive epilepsy portfolio.
  • Relutrigine holds Orphan Drug Designation & Rare Pediatric Disease Designation from the FDA for SCN2A-DEE, SCN8A-DEE, & Dravet syndrome, along with Breakthrough Therapy Designation from the EMA.
  • Vormatrigine is a next-generation, functionally selective small molecule targeting hyperexcitable sodium channels, currently developed as a once-daily oral treatment for adult focal onset seizures & generalized epilepsy.