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.
CEO Ian Mortimer 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.”
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 <0.001 for the 20 mg and 25 mg groups, and XEN1101 was generally well tolerated.
XENE shares spiked $!.68, or 5.5%, to $32.16.
