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Xenon Pharmaceuticals Announces Positive Outcome of End-of-Phase 2 Meeting with the FDA
XEN1101 Phase 3 program for the treatment of focal onset seizures to be initiated in the second half of 2022 and New Drug Application expected to be submitted
About this update from Xenon Pharmaceuticals Inc.
[{"type":"text","content":"XEN1101 Phase 3 program for the treatment of focal onset seizures to be initiated in the second half of 2022 and New Drug Application expected to be submitted after completion of first Phase 3 clinical trial (X-TOLE2) along with the completed Phase 2b (X-TOLE) clinical trial Plans to initiate XEN1101 Phase 3 clinical trial (X-ACKT) in an additional epilepsy indication of primary generalized tonic clonic seizures BURNABY, British Columbia, June 21, 2022 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neurology-focused biopharmaceutical company, today announced next steps in its clinical program evaluating XEN1101 for the treatment of patients with focal onset seizures (FOS) following the completion of an End-of-Phase 2 (EOP2) meeting with the U.S. Food & Drug Administration (FDA). The outcome of the EOP2 meeting supports the advancement of XEN1101 into Phase 3 clinical development, and Xenon remains on track to initiate the Phase 3 program in the second half of 2022. Mr. Ian Mortimer, Xenon’s President and Chief Executive Officer, stated, “The successful completion of our EOP2 meeting with the FDA marks another important milestone in our XEN1101 program, and we are excited to advance XEN1101 into Phase 3 development. One of Xenon’s key goals is to deliver innovative medicines that improve the lives of patients with epilepsy. Supported by the strong data generated from our Phase 2b ‘X-TOLE’ clinical trial, we believe XEN1101 has the potential to offer a highly differentiated and competitive profile when compared to other anti-seizure medications based on its unique potassium channel mechanism of action combined with once-a-day dosing in the evening with no titration. We look forward to initiating our Phase 3 program to support a planned NDA submission for XEN1101 with the goal of providing a new therapeutic option for patients with FOS.” The EOP2 meeting was supported by nonclinical and clinical data, including results from the previously completed Phase 1 trials and the positive Phase 2b X-TOLE clinical trial evaluating XEN1101 in adult patients with FOS. The X-TOLE topline efficacy data demonstrated that the primary and secondary seizure reduction endpoints were statistically significant across all three dose groups, with p-values of","length":2705,"tagName":"div"}]