Xenon Pharmaceuticals Inc. XENE, a neurology-focused biopharmaceutical company, today announced ...
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"Interim Long-Term Safety and Efficacy of XEN1101, a Potent, Selective Potassium Channel Opener: Update From an Ongoing, Open-Label Extension of a Phase 2b Study (X-TOLE) in Adults With Focal Epilepsy"
Once daily (QD) dosing of 20 mg of XEN1101 with food yielded long-term efficacy in this interim analysis with 60% retention at 24 months.
During open-label extension (OLE) study months 18 to 30, there was a sustained monthly reduction in seizure frequency (78%–95% median percent change) from double-blind period baseline, and higher reductions were observed for patients who were receiving one to two anti-seizure medications (ASMs) at baseline compared to those receiving three ASMs.
Seizure freedom for ≥3-month, ≥6-month, and ≥12-month consecutive durations was achieved in 37.5%, 22.2%, and 14.9% of all patients enrolled in the OLE (n=275), respectively.
Seizure freedom for ≥3-month, ≥6-month, and ≥12-month consecutive durations was achieved in 56.4%, 34.5% and 23.6% of those patients with at least 24 months of treatment in the OLE (n=165), respectively.
XEN1101 continues to be generally well-tolerated in the OLE with adverse events (AEs) consistent with prior results and other AEs seen with other anti-seizure medications; no new safety signals were identified.
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