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Praxis Precision Medicines Announces Positive, Best-in-Disease Topline Results in Patients with Focal Onset Seizures from the RADIANT Study of Vormatrigine
Globenewswireยท 2025-08-04 12:00
Core Insights - Praxis Precision Medicines announced topline results from the Phase 2 RADIANT study, showing that dosing with vormatrigine over 8 weeks led to a 56.3% median reduction in seizure frequency [1] - Approximately 22% of patients achieved a 100% reduction in seizure frequency during the last 28 days of treatment [1] - Over 54% of patients experienced a 50% response in the first week, indicating a rapid and sustained response [1] - Vormatrigine demonstrated a favorable safety profile and was generally well tolerated [1] Company Overview - Praxis Precision Medicines is a clinical-stage biopharmaceutical company focused on developing therapies for central nervous system disorders characterized by neuronal excitation-inhibition imbalance [7] - The company is applying genetic insights to discover and develop therapies for both rare and prevalent neurological disorders through its proprietary platforms [7] - Praxis has established a diversified CNS portfolio, including multiple programs across epilepsy and movement disorders, with four clinical-stage product candidates [7] Product Details - Vormatrigine is a next-generation, functionally selective small molecule targeting hyperexcitable sodium channels in the brain, developed as a once-daily oral treatment for adult focal onset seizures and generalized epilepsy [6] - Preclinical data suggests that vormatrigine has the potential to be best-in-class for focal epilepsy, demonstrating superior selectivity for disease-state NaV channel hyperexcitability [6] - Initial results from the RADIANT study indicate robust seizure reduction and a generally safe and well-tolerated profile for vormatrigine [6] Future Developments - Praxis plans to complete the pivotal 12-week POWER1 study in Q4 2025 and expects to initiate the POWER2 study shortly based on the results from RADIANT [2] - Additional data from the RADIANT study will be presented at the 36th International Epilepsy Congress on August 31, 2025, in Lisbon, Portugal [4] - A late-breaker abstract for the full study results will be submitted for presentation at the American Epilepsy Society Annual Meeting in December 2025 in Atlanta, Georgia [4]