Praxis Reports Strong EMBOLD And RADIANT Results, Highlighting Rapid And Durable Seizure Reduction Across Programs

Praxis Precision Medicines has reported promising new data from its EMBOLD study evaluating relutrigine for central nervous system disorders driven by neuronal excitation-inhibition imbalance. The company announced that relutrigine was well tolerated and demonstrated rapid, meaningful, and steadily increasing reductions in seizures, along with broad improvements in patient behavior, alertness, communication, and overall clinical status. Praxis plans to meet with the U.S. FDA in the coming weeks to determine next steps for a potential New Drug Application, after which it will finalize the timing of the submission.

In the EMBOLD trial, patients treated with relutrigine achieved a 53% reduction in seizures over 16 weeks, adjusted for placebo, and a 66% increase in motor seizure-free days. Clinician and caregiver assessments both reflected statistically significant improvements across key functional domains, and no drug-related serious adverse events were observed. Most treatment-related side effects were mild or moderate, supporting relutrigine’s favorable safety profile.

“The updates we shared at AES mark a pivotal moment for epilepsy treatment. The EMBOLD results highlight the long-awaited potential of relutrigine to become the first disease modifying treatment for SCN2A and SCN8A-DEE patients and show that we are positioned to deliver the same impact for the broader DEE community,” said Marcio Souza, president and chief executive officer. “Additionally, the update from the RADIANT study for focal-onset seizures and generalized epilepsy confirmed its potential as a best-in-class therapy. We are committed to accelerating these options to patients while continuing to accelerate the broad DEE study, EMERALD, our ASO programs and the FOS studies toward registration.”

Praxis also shared new RADIANT study results for vormatrigine, which the company positioned as a potential best-in-disease therapy for focal onset seizures and generalised epilepsy. Vormatrigine demonstrated fast-acting efficacy without titration, sustained seizure reduction with continued treatment, favourable drug–drug interaction characteristics, and convenient once-daily dosing. In patients with focal onset seizures, median seizure reductions reached 54% over eight weeks, and the effect strengthened over time, with many patients achieving prolonged periods of seizure freedom. Generalised epilepsy patients showed a similar rapid and durable response.

The company is advancing its broader clinical program with steady progress. Recruitment for the pivotal POWER1 study in focal onset seizures is now complete, and the POWER2 study remains on track to finish in the second half of 2026. Praxis expects to initiate the monotherapy POWER3 study in the first half of 2026 as it continues building a robust clinical foundation for its emerging seizure-focused portfolio.