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Xenon Pharmaceuticals Announces Launch of XEN1101 Phase 3 Program with Initiation of X-TOLE2 Clinical Trial in Patients with Focal Onset Seizures
BURNABY, British Columbia, Nov. 03, 2022 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neurology-focused biopharmaceutical company, today
About this update from Xenon Pharmaceuticals Inc.
[{"type":"text","content":"BURNABY, British Columbia, Nov. 03, 2022 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neurology-focused biopharmaceutical company, today announced the launch of its XEN1101 Phase 3 program with the initiation of the X-TOLE2 clinical trial, which will examine XEN1101 administered as an adjunctive treatment for adult patients with focal epilepsy. Mr. Ian Mortimer, Xenon’s President and Chief Executive Officer, stated, “We are thrilled to announce the launch of our XEN1101 Phase 3 program with the initiation of our X-TOLE2 clinical trial. We have ambitious clinical development plans for XEN1101, including our X-TOLE2 and X-TOLE3 clinical trials in focal onset seizures, as well as our Phase 3 X-ACKT clinical trial in primary generalized tonic clonic seizures. We continue to hear from key opinion leaders and prescribing physicians that novel mechanisms are needed to provide new therapeutic options that are clearly differentiated from the anti-seizure medications currently available. Backed by a strong scientific rationale and compelling Phase 2b clinical data, we are focused on advancing XEN1101 through its late-stage clinical development towards commercialization, with the goal of providing new therapies for epilepsy patients in need.” About XEN1101XEN1101 is a differentiated Kv7 potassium channel opener being developed for the treatment of epilepsy and major depressive disorder. 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. In June 2022, Xenon announced the successful completion of an End-of-Phase 2 meeting with the U.S. Food & Drug Administration (FDA). Based on the EOP2 meeting, Xenon and the FDA aligned on key elements of the Phase 3 program to support a New Drug Application (NDA) submission. Xenon plans to submit an NDA upon completion of the first XEN1101 Phase 3 clinical trial (X-TOLE2), if successful, and use the existing data package from the Phase 2b X-TOLE clinical trial along with additional safety data from other clinical trials to meet regulatory requirements. About the XEN1101 Phase 3 ProgramXenon has initiated its XEN1101 Phase 3 development program, which includes two identical Phase 3 clinical trials ...