Xenon Pharmaceuticals Outlines Key Milestone Opportunities for 2022

BURNABY, British Columbia, Jan. 10, 2022 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neurology-focused biopharmaceutical company, today outlined its key milestones for 2022.

Mr. Ian Mortimer, Xenon’s President and Chief Executive Officer stated, “We are entering 2022 with an immense amount of positive momentum, building upon the strong efficacy data from our XEN1101 Phase 2b X-TOLE clinical trial announced in the fourth quarter of 2021. We have set clear business objectives for 2022, with a high priority placed on conducting an end-of-Phase 2 meeting with the FDA in the second quarter of 2022, finalizing our XEN1101 clinical development plans, and initiating our XEN1101 Phase 3 program in the second half of 2022 in adult patients with focal epilepsy. In addition, we are evaluating XEN1101 as a treatment for major depressive disorder, both in an investigator-led study with collaborators at Mount Sinai that is currently underway and in a company-sponsored Phase 2 clinical trial that is expected to begin in the first half of this year.”

Mr. Mortimer added, “Our team is also focused on continuing to support ongoing patient enrollment in our Phase 3 ‘EPIK’ pediatric clinical trial evaluating XEN496 as a treatment of KCNQ2 developmental and epileptic encephalopathy, which is expected to be completed in the first half of 2023. We also look forward to reporting ongoing progress from our partnered programs and discovery pipeline throughout the year.”

Highlights and Anticipated Milestones

Proprietary Programs

XEN1101XEN1101 is a differentiated Kv7 potassium channel opener being developed for the treatment of epilepsy and major depressive disorder (MDD). In October 2021, Xenon announced positive results from its Phase 2b X-TOLE clinical trial, which evaluated the clinical efficacy, safety and tolerability of XEN1101 administered as an adjunctive treatment for adult patients with focal epilepsy. The topline data showed all primary and secondary seizure reduction endpoints were statistically significant across all dose groups, including the primary endpoint of median reduction from baseline in monthly seizure frequency and in the key secondary endpoint of patients with at least a 50% reduction in monthly focal seizure frequency from baseline, with p-values of