Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neurology-focused
biopharmaceutical company, today announced its upcoming oral and
poster presentations at the 2023 American Academy of Neurology
(AAN) Annual Meeting in Boston, MA.
Mr. Ian Mortimer, Xenon’s President and Chief Executive Officer,
stated, “We are excited to showcase our XEN1101 epilepsy program at
the 2023 AAN meeting. In particular, we are looking forward to the
oral presentation by Dr. Jacqueline French, who will outline the
promising results we are seeing in the ongoing open-label extension
study of our Phase 2b X-TOLE clinical trial in focal onset
seizures. XEN1101 represents the most advanced potassium channel
modulator in clinical development for multiple indications, and our
robust Phase 3 plans for XEN1101 include clinical trials already
underway in focal onset seizures as well as primary generalized
tonic-clonic seizures.”
Jacqueline A. French, MD, Professor in the Department of
Neurology at NYU Langone Health and Co-director of Epilepsy
Clinical Trials at NYU Langone's Comprehensive Epilepsy Center;
Founder/Director of the Epilepsy Study Consortium; and Chair of the
XEN1101 X-TOLE Steering Committee, stated, “The interim analysis
from an ongoing open-label extension study with XEN1101 builds upon
the strong efficacy data generated in the Phase 2b X-TOLE clinical
trial. Importantly, patients with epilepsy are experiencing
continued seizure reduction and extended periods of seizure
freedom. These data are encouraging for prescribing physicians who
continue to seek new, differentiated therapeutics that improve upon
existing options. I believe, as XEN1101 progresses through Phase 3
studies, these results also provide further hope for the many
patients who experience the debilitating impacts of focal seizures,
even while taking multiple anti-seizure medications.”
2023 AAN Presentation
Details:
Title: “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”
Format: Oral Presentation #008,
Epilepsy/Clinical Neurophysiology (EEG): Epilepsy Outcomes
Presenter: Jacqueline French, New York
University Grossman School of Medicine and NYU Langone Health, New
York, NY, USA
Date/Time: Thursday, April 27, 2023 at 2:24
pm-2:36 pm ET
Highlights:
- During the
open-label extension (OLE), there was a sustained monthly reduction
in seizure frequency (80%–90% seizure reduction as measured by
median percent change) from the double-blind period baseline.
- Seizure freedom
for ≥6-month and ≥12-month consecutive durations was achieved in
17.5% and 10.5% of patients, respectively.
- XEN1101
continues to be generally well-tolerated in the OLE with adverse
events consistent with prior results and other anti-seizure
medications.
Title: “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”
Format: Poster Session 11, #012
Lead Author: Antonio Gil-Nagel, Hospital Ruber
Internacional, Madrid, Spain
Date/Time: Wednesday, April 26, 2023 at 11:45
am-12:45 pm
Highlights:
- Xenon has initiated a Phase 3
clinical trial, called X-ACKT, to support potential regulatory
submissions in an additional epilepsy indication of primary
generalized tonic-clonic seizures (PGTCS).
- This multicenter, randomized,
double-blind, placebo-controlled study will evaluate the clinical
efficacy, safety, and tolerability of XEN1101 administered as
adjunctive treatment in approximately 160 patients with PGTCS.
- The primary efficacy endpoint is
the MPC in monthly PGTCS frequency from baseline through the
double-blind period of XEN1101 compared to placebo.
Other AAN
Activities:
On Sunday, April 23, 2023, Dr. Christopher
Kenney, Xenon’s Chief Medical Officer, hosted a presentation
entitled “XEN1101, a Novel Potassium Channel Opener in Clinical
Trials for Epilepsy” on the Emerging Neurologic Care Presentation
Stage in the Exhibit Hall.
In addition to the posters noted above, Xenon is
hosting a booth (#1575) in the Exhibit Hall, which is scheduled to
be open from 11:30 am ET on Sunday, April 23, 2023 until 4 pm ET on
Wednesday, April 26, 2023.
About Xenon Pharmaceuticals
Inc.Xenon Pharmaceuticals (NASDAQ:XENE) is 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 potential efficacy, safety profile, future
development plans, addressable market, regulatory success and
commercial potential of our and our partners’ product candidates;
the efficacy of our clinical trial designs; our ability to
successfully develop and achieve milestones in our XEN1101 and
other development programs; and our ability to obtain regulatory
approval of XEN1101 and our other product candidates. 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; 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 the ongoing COVID-19 pandemic 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, may be more severe and
more prolonged than currently anticipated; 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 Securities and
Exchange Commission and the securities commissions in British
Columbia, Alberta, and Ontario. These forward-looking statements
speak only as of the date hereof and we assume no obligation to
update these forward-looking statements, and 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
owner.
Investor/Media Contact:Jodi RegtsXenon
Pharmaceuticals Inc.Phone: 604.484.3353Email:
investors@xenon-pharma.com
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