- Xenon Pharmaceuticals Inc XENE has reported topline results from the Phase 2b X-TOLE trial evaluating XEN1101 as an adjunctive treatment in adult patients with focal epilepsy.
- The trial met its primary efficacy endpoint with XEN1101, demonstrating a statistically significant and dose-dependent reduction from baseline in monthly focal seizure frequency compared to placebo.
- The median percent reduction in monthly focal seizure frequency was 52.8% in the XEN1101 25 mg group, 46.4% in the XEN1101 20 mg group, and 33.2% in the XEN1101 10 mg group compared to 18.2% in the placebo group.
- The percentage of subjects who achieved an over 50% reduction in monthly focal seizures was 54.5% in the XEN1101 25 mg group, 43.1% in the XEN1101 20 mg group, and 28.3% in the XEN1101 10 mg group compared to 14.9% in the placebo group. XEN1101 was generally well-tolerated.
- The incidence of treatment-emergent adverse events (TEAEs) was higher in the treatment groups than in the placebo group.
- The most common TEAEs across all XEN1101 dose groups were dizziness, drowsiness, fatigue, and headache.
- Two TEAEs of urinary retention were reported, one of which required a dose reduction.
- Price Action: XENE stock is up 67.90% at $26.10 during the market session on the last check Monday.
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