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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.
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.
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