Xenon Pharmaceuticals Showcases XEN1101 Epilepsy Program at 35th International Epilepsy Congress
New interim data from ongoing Phase 2b X-TOLE open-label extension demonstrates improvement in overall quality-of-life (QoL) when compared to baseline
Clinically important improvements seen for all patients across important subscales of Seizure Worry, Social Functioning and Medication Effects and for seizure free patients across all QoL subscales
Oral presentations showcase Phase 3 clinical trials in focal onset seizures and primary generalized tonic-clonic seizures
An interim analysis (cutoff date
Newly compiled interim data from the X-TOLE OLE focused on quality-of-life (QoL) measures as assessed using a validated tool called the Quality of Life in Epilepsy Inventory-31 (QOLIE-31) in the overall OLE group as well as a subgroup that was seizure-free (SFG) for at least 12 consecutive months at the time of the interim data analysis. The SFG consisted of 29 patients (approximately 10.5% of those enrolled in the OLE).
- The overall OLE patient group showed improvements in overall Quality of Life
- Clinically important improvements in QOLIE-31 subscales of Seizure Worry, Social Functioning, and Medication Effects were seen across all patients, with even greater improvements in the SFG
- The SFG achieved clinically important improvements in all QoL subscales assessed by the QOLIE-31
- The improvements in Medication Effects across all patients is notable as this measures the patients’ perception of drug tolerability as well as the benefit of long-term seizure reduction
Summary of IEC 2023 Presentations and Poster Sessions
- Poster: “Quality-of-Life Improvements in Adults With Focal Onset Seizures Treated With XEN1101 in an Ongoing, Long-Term, Open-Label Extension of a Phase 2b Study (X-TOLE).”
- Poster: “XEN1101, a Novel Potassium Channel Modulator: Interim Data From an Ongoing, Long-Term, Open-Label Extension of a Phase 2b study (X-TOLE) in Adults With Focal Epilepsy.”
- Oral Presentation: Design of Two Parallel Randomized, Double-Blind, Placebo-Controlled Phase 3 Studies to Evaluate the Safety and Efficacy of XEN1101 as Adjunctive Therapy in the Treatment of Focal Onset Epilepsy.”
- Oral Presentation: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of XEN1101 as an Adjunctive Therapy in the Treatment of Primary Generalized Tonic-Clonic Seizures.”
Presentations and posters will be added to the Xenon website consistent with IEC 2023 conference guidelines.
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 potential efficacy, safety profile, future development plans, addressable market, regulatory success and commercial potential of XEN1101; the efficacy of our clinical trial designs; our ability to successfully develop and achieve milestones in our XEN1101 development program; and our ability to successfully develop and obtain regulatory approval of XEN1101. 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; 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; our ongoing discovery and pre-clinical efforts may not yield additional product candidates; any of our or our collaborators’ product candidates, including XEN1101, 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; the impact of competition; the impact of expanded product development and clinical activities on operating expenses; the impact of new or changing laws and regulations; the impact of pandemics, epidemics and other public health crises on our research and clinical development plans and timelines and results of operations, including impact on our clinical trial sites, collaborators, regulatory agencies and related review times, and contractors who act for or on our behalf; the impact of unstable economic conditions in the general domestic and global economic markets; adverse conditions from geopolitical events; as well as the other risks identified in our filings with the
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Source: Xenon Pharmaceuticals Inc.