Xenon Pharmaceuticals Inc (NASDAQ:XENE) announced additional positive data from new sub-analyses of Phase 2b X-TOLE trial of XEN1101 in adult patients with focal epilepsy. The Data will be presented at the Annual Meeting of the American Epilepsy Society.
Additional primary and secondary measures included a pairwise comparison of each active dose to placebo and a responder analysis.
In October, the Burnaby, British-Columbia-based drug maker announced Xenon announced that the X-TOLE trial had met its primary efficacy endpoint with XEN1101 demonstrating a statistically significant and dose-dependent reduction from baseline in monthly (defined as 28 days) focal seizure frequency when compared to placebo.
Primary and secondary measures in the topline data set included a pairwise comparison of each active dose to placebo and a responder analysis with the proportion of patients who achieved a 50% or greater reduction in monthly focal seizure frequency from baseline.
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 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.
The marked reductions in seizures were associated with statistically significant improvements in overall status.
The most common adverse events across all XEN1101 dose groups were dizziness, somnolence, fatigue, and headache.
XENE shares are up 68 cents, or 2.6% at $26.56 early Friday.
