Xenon Pharmaceuticals Provides Updates on Proprietary Neurology Pipeline Programs at the Annual Meeting of the American Epilepsy Society (AES 2021)
Mr.
The following summarizes Xenon’s presentations at AES 2021 related to its proprietary, clinical stage programs as well as promising pre-clinical work:
Poster: “Phase 2b Efficacy and Safety of XEN1101, a Novel Potassium Channel Modulator, in Adults with Focal Epilepsy (X-TOLE)”
- Please refer to a separate news release also dated today (
December 3, 2021 ) for a detailed summary of the X-TOLE data and completed sub-analyses that will be presented at AES 2021. Xenon is hosting a conference call this morning at9 am ET that will provide an overview of XEN1101 and the Phase 2b X-TOLE study results.
Poster: “Electronic Seizure Diary Compliance in an Adult Focal Epilepsy Clinical Trial”
- These data indicate that high eDiary compliance could be maintained in adults with focal onset epilepsy (FOS), aided by central monitoring in real time, potentially setting a new standard for FOS studies.
Poster: “XEN1101, a Differentiated Kv7 Potassium Channel Modulator, Impacts Depression and Anhedonia”
- Depression is a common co-morbidity of persons with epilepsy and significantly impacts their quality of life. These pre-clinical data support the hypothesis that XEN1101 may have beneficial impacts on mood at plasma concentrations that are efficacious for seizure reduction.
Poster: “Pathogenic and Likely Pathogenic Variants in KCNQ2 Underlie a Large Majority of Genetic Epilepsy in Neonates and Infants <6 Months of Age”
- Pathogenic variants in KCNQ2 are the most common cause of genetic epilepsy during early infancy and diagnostic yield for KCNQ2 is high in patients with seizure onset <6 months of age. Early diagnosis has important implications in informing prognosis and treatment strategies including access to potential precision therapies in clinical development, such as XEN496.
Poster: “Nav1.1 Selective Potentiators Normalize Inhibition/Excitation Imbalance and Prevent Seizures in a Mouse Model of Dravet Syndrome”
- This pre-clinical work suggests that a Nav1.1 potentiator profile provides a new, mechanistically differentiated class of voltage-gated sodium channel compounds with the potential to provide an improved therapeutic profile for the overarching treatment of Dravet Syndrome.
On
- “Design of a Clinical Trial to Determine the Efficacy of XEN496 in KCNQ2 Developmental and Epileptic Encephalopathy (KCNQ2 DEE)”
- “Pharmacokinetic (PK) and Food Effect Assessment of XEN496, a Pediatric Formulation of Ezogabine, in Healthy Adults and Retrospective PK and Safety Comparison with Potiga®”
- “Pathogenic and Likely Pathogenic Variants in KCNQ2 Underlie a Large Majority of Genetic Epilepsy in Neonates and Infants <6 Months of Age”
- “Evaluating the Epidemiological Burden of KCNQ2 Epilepsy”
Conference Call Information
Xenon will host a conference call and live webcast today at
About
We are a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders. We are advancing a novel product pipeline of neurology therapies to address areas of high unmet medical need, with a focus on 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, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, 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 clinical trials and pre-clinical development activities, including those related to XEN496, XEN1101, and other proprietary products; the potential efficacy, safety profile, future development plans, addressable market, regulatory success and commercial potential of XEN496, XEN1101 and other proprietary product candidates; the anticipated timing of IND, or IND-equivalent, submissions and the initiation of future clinical trials for XEN496, XEN1101, and other proprietary products; the efficacy of our clinical trial designs; our ability to successfully develop and achieve milestones in XEN496, XEN1101, and other proprietary development programs; the timing and results of our interactions with regulators; anticipated enrollment in our clinical trials and the timing thereof; 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: the impact of the COVID-19 pandemic on our business, research and clinical development plans and timelines and results of operations, including impact on our clinical trial sites, collaborators, and contractors who act for or on our behalf, may be more severe and more prolonged than currently anticipated; clinical trials may not demonstrate safety and efficacy of any of our or our collaborators’ product candidates; promising results from pre-clinical development activities or early clinical trial results may not be replicated in later clinical trials; our assumptions regarding our planned expenditures and sufficiency of our cash to fund operations may be incorrect; any of our or our collaborators’ product candidates, including XEN1101 and XEN496, may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; regulatory agencies may be delayed in reviewing, commenting on or approving any of our or our collaborators’ clinical development plans as a result of the COVID-19 pandemic, which could further delay development timelines; the impact of competition; the impact of expanded product development and clinical activities on operating expenses; impact of new or changing laws and regulations; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the
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Source: Xenon Pharmaceuticals Inc.