Jannah Theme License is not validated, Go to the theme options page to validate the license, You need a single license for each domain name.
Business

Xenon Pharmaceuticals will provide an update on its unique neurology pipeline program at the American Epilepsy Society (AES 2022) Annual Meeting in the Canadian Business Journal.

Additional Positive Data Announced from Open-Label Extension of Phase 2b ‘X-TOLE’ Clinical Trial in Focal Onset Seizures

The XEN1101 Phase 3 program will be showcased at the Science Exhibition on Sunday, December 4, 2022

BURNABY, British Columbia, December 2, 2022 (GLOBE NEWSWIRE) — Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neurology-focused biopharmaceutical company, announced today at its 2022 Annual Meeting that it is announced that it will provide updates on its academic programs. American Epilepsy Society (AES 2022). In addition, the company is presenting results from the open-label extension (OLE) and sub-analysis of data from the XEN1101 Phase 2b X-TOLE clinical trial.

Ian Mortimer, President and Chief Executive Officer of Xenon, said: Xenon will have a significant presence at his AES this year. There will be seven poster presentations and a scientific exhibit showcasing his recently initiated XEN1101 Phase 3 program and planned clinical trials in partial-onset seizures and primary generalized tonic-clonic seizures. I also look forward to meeting with leading epileptologists, including Xenon trial researchers and patient advocacy groups, at this important conference. ”

Mortimer continues: In this interim analysis, XEN1101 was generally well-tolerated, with long-term efficacy at his once-daily dosing of 20 mg, and the patient demonstrated continued seizure reduction during her OLE period. and prolonged seizure-free periods. Two other of his XEN1101-related posters outline additional sub-analyses of the X-TOLE data suggesting a rapid onset of efficacy for XEN1101, with all doses investigated when compared to placebo. There was a statistically significant reduction in focal seizures within 1 week at Moreover, based on the number of concomitant ASMs, baseline seizure frequency, and number of failed antiseizure medications, the X-TOLE study identified more ‘hard-to-treat’ patients than other similar focal seizure studies. We have enrolled. We believe this is important as it suggests that the efficacy of XEN1101 may be stronger in patients with less severe disease. 3-phase program started. The program hopes to confirm these promising results and continue with the goal of providing new, differentiated therapies that may play an important role in the treatment of patients with epilepsy. ”

XEN1101 AES poster highlights

Poster No. 2.235 (French et al.) “XEN1101, a novel potassium channel modulator: Interim data from the ongoing long-term open-label extension of the Phase 2B study (X-TOLE) in adults with focal epilepsy”

  • As of the analysis cutoff date of September 22, 2022, there was a sustained reduction in monthly seizure frequency from baseline in the double-blind period (DBP) during the OLE period (80% as measured by MPC). ~90% seizure reduction).
  • A seizure-free period of ≥6 months and ≥12 consecutive months was achieved in 17.5% and 10.5% of patients, respectively.
  • XEN1101 remains generally well tolerated in OLE with adverse events (AEs) consistent with previous results and other antiepileptic drugs (ASMs).
    • At the end of the first year of OLE, patients recorded a mean (SD) weight gain of 1.1 (5.9) kg.
    • To date, two OLE-related AEs of urinary retention have occurred that were considered study drug-related. Both patients continued on study without requiring intervention.
    • Although not observed to date, xenon continues to monitor the appearance of tissue discoloration associated with long-term exposure to ezogabine.

Poster #2.236 (Kenney et al.) “Rapid onset of efficacy of XEN1101, a novel potassium channel opener in adults with focal epilepsy: results from a phase 2b trial (X-TOLE)”

  • X-TOLE met primary and key secondary efficacy endpoints with XEN1101, with a statistically significant dose-dependent reduction in monthly focal seizure (FOS) frequency from baseline compared to placebo showed that it did
  • The rapid onset of efficacy of XEN1101 was associated with initiation at effective, therapeutic and well-tolerated doses. Compared to placebo, he had a statistically significant reduction in median FOS frequency within 1 week at all doses.
  • The rapid onset and sustained efficacy of XEN1101 after 1 week, if confirmed in a Phase 3 clinical trial, may make XEN1101 an attractive option for patients seeking adjuvant therapy. suggests that there is

Poster No. 2.233 (Leung et al.) “Impact of disease severity on efficacy from a phase 2b trial of XEN1101, a novel potassium channel opener, in adults with focal epilepsy (X-TOLE)”

  • X-TOLE met primary and co-primary secondary efficacy endpoints with XEN1101, with a statistically significant dose-dependent reduction in monthly FOS frequency from baseline compared to placebo in the difficult-to-treat population showed.
  • Based on the number of concomitant ASMs, baseline seizure frequency, and number of failed ASMs, the X-TOLE study enrolled more difficult-to-treat patients than other FOS studies. In the 25 mg dose group, XEN1101 was divided into a subgroup of patients with ≤8.5 seizures per month and a subgroup of patients who failed ≤6 ASMs or had 1–2 concomitant ASMs. Groups reduced seizure frequency by 70.6%, 58.0%, and 60.9%. respectively, compared to placebo (18.8%, 20.0%, 14.2%, respectively).
  • These post-hoc analyzes suggest that efficacy may be stronger in patients with less severe disease and may represent the most common clinical use of XEN1101 if commercially approved. there is.

Xenon Science Exhibit and Booth

In addition to the poster above, Xenon will host a scientific exhibit at AES 2022, Clinical and Research on Sunday, December 4, 2022 from 2-5pm CT in Room 207 C, Level 2, Music City Center I will give an overview of the program. This presentation will demonstrate the phase 3 trial design of XEN1101, including X-TOLE2 and X-TOLE3 for FOS, X-ACKT for primary generalized tonic-clonic seizures, and X-NOVA for major depressive disorder. An overview of the Phase 2 study design is presented. hindrance. Other poster presentations will discuss additional programs in Xenon’s neurology-focused pipeline.

Xenon will open at 12:00 PM CT on Saturday, December 3, 2022 and will also have a booth (#1028) in the exhibit hall on Monday, December 5, 2022 at 2:00 PM CT. We are hosting.

Other AES poster highlights

Other Xenon posters at AES 2022 include clinical research related to Xenon’s XEN496 program and KCNQ2’s ongoing Phase 3 EPIK clinical trial in pediatric patients with developmental and epileptic encephalopathy.

  • Poster 1.370 (Grayson et al.) ‘Genetic burden KCNQ2 Newborn with epilepsy”
  • Poster 1.372 (Harden et al.) ‘Online Survey of Patient Caregivers’ KCNQ2 Developmental and epileptic encephalopathy”
  • Poster 2.334 (Butterfield et al.) KCNQ2 Disease management generated through new data platforms”

Xenon also publishes preclinical studies from discovery efforts related to Na exploration.1.1 Enhancers for the treatment of Dravet Syndrome:

  • Poster 3.049 (Goodchild et al.) “Molecularly selective Na1.1 Potentiators enhance the excitability of PV+ fast-spiking interneurons and restore motor performance in a mouse model of Dravet syndrome.”

Posters will be added to the Xenon website consistent with the AES 2022 conference guidelines.

About Xenon Pharmaceuticals

Xenon Pharmaceuticals (NASDAQ:XENE) is a clinical-stage biopharmaceutical company committed to developing innovative therapies to improve the lives of patients with neurological disorders. We are advancing a new product pipeline in neurotherapy to address an area of ​​high unmet medical need with a focus on epilepsy. For more information, see: www.xenon-pharma.com.

safe harbor declaration

This press release contains 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 forward-looking statements in the meaning of Canadian securities. contains a description of law. These forward-looking statements are not based on historical facts and include statements regarding the timing and potential results of clinical trials. the potential efficacy, safety profile, future development plans, market addressable, regulatory success and commercial potential of our and our partners’ product candidates; Effectiveness of our clinical trial design. Ability to develop and achieve milestones in development programs. Timing and outcome of interactions with regulators. our ability to successfully develop and obtain regulatory approval for XEN1101 and other product candidates; Your intention to participate in our clinical trials and the timing of your participation. These forward-looking statements are subject to risks, uncertainties and the potential for actual results, events or developments to differ materially from those expressed or implied by such forward-looking statements. based on current assumptions, including the factors of These risks and uncertainties, many of which are beyond our control, include, but are not limited to: Promising results from preclinical development activities or early clinical trial results may not be replicated in later clinical trials. Our assumptions regarding cash adequacy for planned expenditures and business funding may not be correct. Our ongoing discovery and preclinical efforts may not yield additional product candidates. Our or our collaborators’ product candidates, including XEN1101, may fail in development, may not receive necessary regulatory approvals, or may be delayed until they are no longer commercially viable. I have. Additional milestones may not be achieved through our own or affiliated programs. Regulators may impose additional requirements or delay the start of clinical trials. the impact of competition; the impact of product development and increased clinical activity on operating costs; the effect of new or changed laws and regulations; Impact of the ongoing COVID-19 pandemic on our research and clinical development plans, timelines and operational outcomes. This includes our clinical trial sites, collaborators, regulatory authorities and related review times, as well as impacts on our behalf or contractors acting on our behalf. It could be more serious and lasting than currently expected. Business Impact of the COVID-19 Pandemic. The impact of unstable economic conditions on general domestic and global economic markets. adverse conditions resulting from geopolitical events; and other risks identified in filings with the Securities and Exchange Commission and the Securities Commissions of British Columbia, Alberta and Ontario. These forward-looking statements speak only as of the date hereof, and we undertake no obligation to update these forward-looking statements. Readers are cautioned not to place undue reliance on such forward-looking statements.

“Xenon” and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owners.

Investor/Media Contact:
Jody Legtz
Xenon Pharmaceuticals Inc.
Phone: 604.484.3353
Email: [email protected]


CBJ Newsmaker

Xenon Pharmaceuticals will provide an update on its unique neurology pipeline program at the American Epilepsy Society (AES 2022) Annual Meeting in the Canadian Business Journal.

Source link Xenon Pharmaceuticals will provide an update on its unique neurology pipeline program at the American Epilepsy Society (AES 2022) Annual Meeting in the Canadian Business Journal.

Related Articles

Back to top button