Xenon Pharmaceuticals Announces Publication of Results from XEN1101 Phase 2b "X-TOLE" Clinical Trial in Peer-Reviewed Journal Article in JAMA Neurology
Xenon Pharmaceuticals Inc., a leading biopharmaceutical company focused on neurology, has recently announced a significant milestone in the development of XEN1101, a novel potassium channel opener for the treatment of epilepsy. The results of the Phase 2b randomized clinical trial of XEN1101 have been published in the prestigious medical journal JAMA Neurology, highlighting the efficacy and safety of the drug in adults with focal epilepsy.
The findings from this clinical trial have provided strong support for the further clinical development of XEN1101 in epilepsy. Currently, the drug is undergoing Phase 3 clinical trials for the treatment of focal onset seizures and primary generalized tonic-clonic seizures. These trials aim to evaluate the drug’s effectiveness and safety in a larger patient population.
Mr. Ian Mortimer, President and CEO of Xenon Pharmaceuticals, expressed his satisfaction with the publication of the peer-reviewed results in JAMA Neurology. He emphasized the positive impact of XEN1101, stating that the drug has demonstrated sustained seizure reduction and a compelling product profile with once-daily dosing and no titration required. This is particularly significant considering the need for new antiseizure medications that are both effective and well-tolerated.
The Phase 2b X-TOLE study evaluated the efficacy and safety of XEN1101 in adults with focal epilepsy. The primary efficacy endpoint was the median percent change from baseline in monthly focal onset seizure frequency. The study included 325 patients, with a mean age of 40.8 years, and the majority of participants identified as White. The results showed a robust dose-response relationship, with XEN1101 treatment leading to a significant reduction in seizure frequency compared to placebo.
Importantly, XEN1101 was generally well-tolerated, with treatment-emergent adverse events (TEAEs) similar to those commonly associated with other antiseizure medications. No TEAEs leading to death were reported during the study, further highlighting the drug’s safety profile.
Xenon Pharmaceuticals remains committed to advancing the development of XEN1101 and obtaining regulatory approval. The company is currently conducting Phase 3 trials, including the X-TOLE2 and X-TOLE3 studies for focal onset seizures, as well as the X-ACKT study for primary generalized tonic-clonic seizures. The ongoing open-label extension study is also providing valuable long-term data on the drug’s efficacy.
Looking ahead, Xenon Pharmaceuticals is eager to present additional data from the X-TOLE open-label extension study at the upcoming annual meeting of the American Epilepsy Society in December 2023. The company’s dedication to addressing the unmet medical needs of patients with neurological disorders, particularly epilepsy, underscores its commitment to improving the lives of those affected.
Xenon Pharmaceuticals Inc. is a clinical-stage biopharmaceutical company focused on developing innovative therapies for neurological disorders. With a strong pipeline of neurology therapies, the company aims to make a significant impact in areas of high unmet medical need. For more information about Xenon Pharmaceuticals and its ongoing research, please visit their official website.