Business
Xenon Pharmaceuticals Outlines Key Milestone Opportunities for 2023
XEN1101 Phase 3 Epilepsy Program Ongoing in Focal Onset Seizures and Recently Initiated in Primary Generalized Tonic Clonic Seizures Strong financial position
About this update from Xenon Pharmaceuticals Inc.
[{"type":"text","content":"XEN1101 Phase 3 Epilepsy Program Ongoing in Focal Onset Seizures and Recently Initiated in Primary Generalized Tonic Clonic Seizures Strong financial position expected to fully support XEN1101 Phase 3 program development and cash runway into 2026 BURNABY, British Columbia, Jan. 09, 2023 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neurology-focused biopharmaceutical company, today outlined recent progress in its clinical programs and key milestones for 2023. Mr. Ian Mortimer, Xenon’s President and Chief Executive Officer, stated, “We enter 2023 in a strong position with increasing momentum in our XEN1101 Phase 3 program, which represents the most advanced potassium channel modulator in clinical development for multiple indications. With our X-TOLE2 study underway in focal onset seizures, we are excited to announce the initiation of our Phase 3 X-ACKT clinical trial in primary generalized tonic clonic seizures.” Mr. Mortimer continued, “We believe XEN1101 shows immense promise based on its validated mechanism of action and a robust data package, including efficacy data from our Phase 2b X-TOLE clinical trial and read-outs from our ongoing open-label extension study. Having established alignment with the FDA on our Phase 3 program and NDA filing requirements, we remain sharply focused on advancing XEN1101 with the goal of improving outcomes for epilepsy patients where there continues to be a significant need for new, differentiated anti-seizure medications.” Mr. Mortimer added, “In parallel with the work supporting the continued advancements of our Phase 3 XEN1101 program, we also anticipate clinical data read-outs in 2023. In the third quarter of this year, we expect the topline data readout from our Phase 2 X-NOVA clinical trial, a proof-of-concept study examining the use of XEN1101 in major depressive disorder. In addition, our partners at Neurocrine expect to have a clinical read-out from their Phase 2 study in adult patients with focal onset seizures in the second half of this year.” Highlights and Anticipated Milestones XEN1101XEN1101 is a differentiated Kv7 potassium channel opener being developed for the treatment of epilepsy and major depressive disorder (MDD). XEN1101 for Focal Onset SeizuresXenon has initiated its XEN1101 Phase 3 development program, which includes two identical Phase 3 clinical trial...