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TOPLINE:
Adding the novel drug XEN1101 to current antiseizure regimens significantly decreases seizures in patients with treatment-resistant focal epilepsy and can safely be taken at its highest dose, results of a new phase 2b study show.
METHODOLOGY:
The double-blind phase 2b study randomized 325 patients with focal onset seizures (FOS), mean age 40.8 years and 91.7% White, who had failed an average of six treatments, to receive oral placebo or 10 mg, natrol tonalin cla 1200 mg 90 softgels review 20 mg, or 25 mg of XEN1101, a novel, small-molecule, selective Kv7.2/Kv7.3 potassium channel opener with a long half-life (about 10 days), daily for 8 weeks.
Researchers assessed the efficacy, safety, and tolerability of XEN1101 compared with placebo.
Secondary analyses included assessment of 50% responder rates and effects of each XEN1101 dose on seizure frequency in weekly intervals to determine speed of onset and durability of response.
TAKEAWAY:
The median percent reduction from baseline in monthly FOS frequency was 52.8% (P < .001 vs placebo) in the 25 mg group, 46.4% (P < .001 vs placebo) in the 20 mg group, and 33.2% (P = .04 vs placebo) in the 10 mg group, compared with 18.2% in the placebo group.
At 25 mg per day, the 50% or more responder rate was 54.5% compared to 14.9% with placebo.
The onset of response was rapid as assessed by post hoc analysis of the percentage of patients who were responders at the end of the first week.
XEN1101 was generally well tolerated, with treatment-emergent adverse effects (TEAEs) consistent with other antiseizure medications (ASMs) and balanced between groups; the most common TEAEs that included dizziness, somnolence, and fatigue appeared to be dose related, and there were no signs of heart problems, allergic reactions, or concerning skin discolorations.
IN PRACTICE:
“Despite the introduction into clinical practice in recent decades of several ASMs for the treatment of FOSs, clinicians continue to seek new treatment options that have the potential to confer seizure freedom for patients who continue to have uncontrolled seizures,” the investigators write. “The results of this study suggest that XEN1101 may be such an option,” they add.
SOURCE:
The study was led by Jacqueline French, MD, professor, Department of Neurology, New York University, New York City, and director, The Epilepsy Study Consortium. It was published October 9, 2023, in JAMA Neurology.
LIMITATIONS:
The study was relatively short although an ongoing open-label extension phase should provide insight into the long-term safety and efficacy. There were fewer individuals in the 10 and 20 mg groups compared with the placebo and 25 mg groups even though a clear dose response was demonstrated. It’s possible pandemic restrictions on site access may have impacted enrollment.
DISCLOSURES:
The study was funded by Xenon Pharmaceuticals Inc., a biotechnology company and maker of XEN1101. French has served as a consultant for Xenon Pharmaceuticals Inc. and has received past research and travel support from the company.
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