Xenon Pharma presents additional positive data from Phase 2b X-TOLE trial at AES 2021
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- Xenon Pharmaceuticals (NASDAQ:XENE) announces that additional positive data from new sub-analyses of the Phase 2b X-TOLE clinical trial will be presented at the Annual Meeting of the American Epilepsy Society (AES 2021).
- On October 4, 2021, the company announced that the X-TOLE trial had met its primary efficacy endpoint in mid-stage focal epilepsy study with XEN1101 demonstrating a statistically significant and dose-dependent reduction from baseline in monthly focal seizure frequency when compared to placebo (monotonic dose response; p<0.001).
- Results from new sub-analyses are consistent with positive topline data and demonstrate strong efficacy across responder subgroups and increased efficacy in patients with less severe disease.
- More than half of the patients in the 25 mg dose group experienced at least a 50% reduction in monthly focal seizure frequency from baseline, and, further, more than 50% of those patients experienced a 75% or greater reduction in monthly focal seizure frequency from baseline.
- In those patients with less severe seizure burden at baseline (less than or equal to 8.5 seizures per month), we saw seizure freedom rates of 17.6% and 13.8% in the 20 mg and 25 mg dose groups, respectively.
- Based on these results, the company believes XEN1101 has a highly competitive and differentiated clinical profile when compared to other ASMs and could play an important role in treating focal epilepsy.