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Xenon Pharmaceuticals Provides Update on Additional Positive Data from the XEN1101 Program
New XEN1101 Phase 2b X-TOLE sub-group analysis demonstrates statistically significant efficacy results at all doses at Week 1, differentiating XEN1101 with
About this update from Xenon Pharmaceuticals Inc.
[{"type":"text","content":"New XEN1101 Phase 2b X-TOLE sub-group analysis demonstrates statistically significant efficacy results at all doses at Week 1, differentiating XEN1101 with rapid onset to seizure reduction New XEN1101 OLE data demonstrates continued seizure reduction exceeding 70% at 3 months in OLE and exceeding 80% at 12 months in OLE BURNABY, British Columbia, June 22, 2022 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neurology-focused biopharmaceutical company, today announced new, compelling efficacy data supporting the late-stage, Phase 3 development of XEN1101. Mr. Ian Mortimer, Xenon’s President and Chief Executive Officer, stated, “We have generated additional efficacy data from sub-group analyses of our Phase 2b X-TOLE trial, which further support our Phase 3 development plans for XEN1101. A ‘time course to efficacy’ analysis shows that all doses of XEN1101 rapidly reduced the frequency of focal onset seizures within one week compared to placebo, suggesting that XEN1101 may offer a compelling and differentiated option for patients seeking to quickly reduce seizure frequency.” Dr. Christopher Kenney, Xenon’s Chief Medical Officer, commented, “Based on these Phase 2b efficacy data, we are including the secondary endpoint of ‘Week 1 median percent change in seizure frequency’ within the statistical hierarchy of the Phase 3 focal onset seizure trials to build upon the differentiated profile of XEN1101. Additionally, within our analysis of the open label extension (OLE) population, we are seeing seizure frequency continuing to improve after the double-blind period with patients experiencing increased periods of seizure freedom. At the request of study investigators and based on the potential to continue to provide significant benefit to patients, we are extending the X-TOLE OLE from three to five years.” Summary of New XEN1101 Data from Phase 2b X-TOLE and Ongoing OLE XEN1101 rapidly reduced focal onset seizure (FOS) 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 (p","length":2616,"tagName":"div"}]