|View printer-friendly version|
|Xenon Pharmaceuticals Advances Second Proprietary Epilepsy Product into the Clinic with Initiation of XEN901 Phase 1 Clinical Trial|
XEN901 is a potent, highly selective Nav1.6 sodium channel inhibitor being developed by Xenon for the treatment of epilepsy, including treatment resistant adult and pediatric focal seizures, as well as rare, pediatric forms of epilepsy, such as EIEE13, an early infantile epileptic encephalopathy associated with gain-of-function mutations in the SCN8A gene, which encodes the Nav1.6 sodium channel.
Dr. Pimstone added, “We expect that XEN901 will follow a similar clinical development path to XEN1101, Xenon’s novel Kv7 potassium channel opener for the treatment of epilepsy, which is also currently in Phase 1 development. If supported by the data, these Phase 1 clinical trials will be followed by Phase 2 proof-of-concept trials evaluating efficacy in the treatment of adult focal seizures. We are also examining the advancement of these therapies in a pediatric setting as soon as possible in order to specifically target the underlying genetic mutations in rare forms of early infantile epileptic encephalopathies that lead to marked development impairment in many cases.”
Xenon has examined XEN901 in a preclinical model of genetically defined epilepsy as well as models representative of focal seizures. These studies showed that XEN901 is efficacious against seizures in both an SCN8A (Nav1.6) gain-of-function model, which is designed to be predictive of the pediatric genetic epilepsy EIEE13, and in the maximal electroshock seizure (MES) model, which is designed to be predictive of adult focal seizures. When compared to phenytoin in both the SCN8A and MES models, XEN901 achieved the same degree of efficacy as phenytoin at one thousand fold lower brain exposures. XEN901 was observed to have an improved therapeutic index relative to phenytoin as assessed by tests of rodent behavior and motor impairment.
XEN901 Phase 1 Clinical Trial Design
About Focal Seizures
About Early Infantile Epileptic Encephalopathy (EIEE13)
Xenon is a clinical stage biopharmaceutical company focused on developing innovative therapeutics to improve the lives of patients with neurological disorders. Building upon our extensive knowledge of human genetics and diseases caused by mutations in ion channels, known as channelopathies, we are advancing – both independently and with our pharmaceutical collaborators – a novel product pipeline of ion channel modulators to address therapeutic areas of high unmet medical need, such as pain and epilepsy. For more information, please visit www.xenon-pharma.com.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995 and Canadian securities laws. These forward-looking statements are not based on historical fact, and include statements regarding the timing of and results from our clinical trials and pre-clinical development activities related to XEN901, XEN1101 and our other product candidates, the potential efficacy, safety profile, future development plans, addressable market, regulatory success and commercial potential of XEN901, XEN1101 and our other product candidates, the anticipated timing of IND, or IND equivalent, submissions and the initiation of future clinical trials for XEN901, XEN1101 and our other product candidates, our ability to successfully develop and achieve milestones in the XEN901, XEN1101 and other development programs, the anticipated benefits of XEN901’s unique composition, the efficacy of our clinical trial design and anticipated enrollment, and the progress and potential of our other ongoing development programs. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: clinical trials may not demonstrate safety and efficacy of any of our or our collaborators' product candidates; our efforts to expand our current pipeline, including through the advancement of XEN901 into clinical development, may not be successful; any of our or our collaborators' product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; the impact of competition; the impact of expanded product development and clinical activities on operating expenses; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the
“Xenon” and the Xenon logo are registered trademarks or trademarks of