- Xenon Pharmaceuticals Inc (NASDAQ:XENE) announced new efficacy data supporting the Phase 3 development of XEN1101.
- XEN1101 rapidly reduced focal onset seizure frequency within one week for all doses compared with placebo.
- At Week 1, the median percent reduction in monthly focal onset seizure frequency was 55.4% in the 25 mg group, 41.5% (20 mg), and 39.1% (10 mg) compared to 20.2% in the placebo group.
- Based on the data, a key secondary endpoint in the Phase 3 trials will include the median percent change of weekly FOS at Week 1.
- Related: Xenon Stock Jumps On New Encouraging Data From Epilepsy Treatment.
- Seizure frequency continued to improve for the open-label extension (OLE) population during the first month after the 8-week double-blind period (DBP), suggesting that the efficacy signal can persist and may improve in the planned 12-week DBP of the XEN1101 Phase 3 trials.
- Subjects remaining in the X-TOLE OLE for at least three months and 12 months experienced a greater than 70% and 80% reduction in median monthly seizure frequency compared to the DBP baseline.
- 54 (19.6%) and 26 (9.5%) of subjects in the OLE experienced a ≥6 and a ≥12 consecutive months of seizure freedom, respectively.
- Xenon also priced its underwritten public offering of 7.9 million shares and pre-funded warrants to purchase up to 327,868 shares at $30.50 per common share, with gross proceeds of $250 million.
- Price Action: XENE shares are down 13.52% at $30.01 during the premarket session on the last check Thursday.
