Xenon Pharmaceuticals outlines milestone opportunities for 2024

Xenon Pharmaceuticals outlined progress within its pipeline programs and key milestones for 2024. Pipeline Programs and Anticipated Milestones: XEN1101 is a novel, potent Kv7 potassium channel opener being developed for the treatment of epilepsy, major depressive disorder, and potentially other neurological disorders. Xenon anticipates that patient enrollment in X-TOLE2 will be completed in the second half of 2024. XEN1101 for Epilepsy: Xenon’s Phase 3 X-ACKT clinical trial is intended to support potential regulatory submissions in an additional epilepsy indication of primary generalized tonic-clonic seizures, or PGTCS. This multicenter, randomized, double-blind, placebo-controlled study is evaluating the clinical efficacy, safety, and tolerability of 25 mg of XEN1101 administered with food as adjunctive treatment in approximately 160 patients with PGTCS. XEN1101 for Epilepsy: Upon completion of the double-blind period in X-TOLE2, X-TOLE3, or X-ACKT, eligible patients may enter an open-label extension, or OLE, study for up to three years. In addition, the ongoing X-TOLE Phase 2b OLE continues to generate important long-term data for XEN1101. XEN1101 for Major Depressive Disorder: Xenon is actively assessing various clinical and regulatory pathways to support late-stage clinical development of XEN1101 in MDD and expects to initiate the Phase 3 clinical program in 2024. Xenon is also evaluating other potential indications for the future development of XEN1101. In addition, Xenon is collaborating with the Icahn School of Medicine at Mount Sinai to support an ongoing investigator-sponsored Phase 2 proof-of-concept, randomized, parallel-arm, placebo-controlled multi-site study of XEN1101 for the treatment of MDD in approximately 60 subjects. Partnered Programs: Xenon has an ongoing collaboration with Neurocrine Biosciences to develop treatments for epilepsy. Pre-Clinical Programs: Xenon continues to leverage its extensive ion channel expertise and drug discovery capabilities to identify validated drug targets and develop new product candidates. The near-term focus is on development candidates targeting Kv7, Nav1.1 and Nav1.7 where Xenon expects multiple candidates will enter IND-enabling studies in 2024 and 2025. Additional updates will be provided as these pre-clinical drug candidates advance through IND-enabling studies and into clinical development.