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Xenon Showcases New 48-Month Azetukalner OLE Study Data in Epilepsy at AES 2025
Monthly reductions in seizure frequency of 90.9% among participants treated for ≥48 months in the OLE, with 38% achieving ≥1 year of seizure freedomNew X-TOLE
About this update from Xenon Pharmaceuticals Inc.
[{"type":"text","content":"Monthly reductions in seizure frequency of 90.9% among participants treated for ≥48 months in the OLE, with 38% achieving ≥1 year of seizure freedomNew X-TOLE OLE data analysis supports the ability to attain and regain extended periods of seizure freedom with long-term use of azetukalner, even in patients with difficult-to-treat diseaseFour real-world study posters illustrate significant burden of depression and ASM titration on people living with epilepsy; poster on impact of depression on outcomes and treatment patterns in patients with newly diagnosed epilepsy highlighted in AES press programNew pre-clinical data in Dravet syndrome suggest potential to improve motor function through NaV1.1 potentiation VANCOUVER, British Columbia and BOSTON, Dec. 05, 2025 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq: XENE), a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development and commercialization of life-changing therapeutics for patients in need, today announced new data highlighting its commitment in epilepsy, including interim 48-month data from its ongoing X-TOLE open-label extension (OLE) study of azetukalner in patients with focal onset seizures (FOS), multiple real world studies on the burden of depression and anti-seizure medication (ASM) titration in epilepsy, and new data for its pre-clinical program in Dravet syndrome. These data are being presented at the American Epilepsy Society Annual Meeting (AES 2025), taking place December 5-9, 2025 in Atlanta, Georgia. “We are excited to share the latest update from our ongoing X-TOLE OLE study of azetukalner. The data show impressive monthly reductions in seizure frequency of over 90% at 48 months in the OLE, with a 100% monthly reduction observed among patients receiving 1-2 ASMs at baseline, and an AE profile comparable to the double-blind period,” said Chris Kenney, MD, Chief Medical Officer at Xenon. “We are also sharing a new analysis characterizing intervals of seizure freedom in the X-TOLE OLE, which we believe presents a clinically relevant real-world view of seizure freedom. These data indicate that even after patients had a breakthrough seizure, most could regain extended periods of seizure freedom with continued azetukalner treatment. Additionally, new findings reveal that a meaningful proportion of participants achieved p...