Xenon Pharmaceuticals Showcases XEN1101 Epilepsy Program at 35th International Epilepsy Congress
2023年9月4日 - 9:30PM
Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neurology-focused
biopharmaceutical company, today announced a summary of its oral
and poster presentations at the 35th International Epilepsy
Congress (IEC) taking place in Dublin, Ireland from September 2-6,
2023.
Mr. Ian Mortimer, Xenon’s President and Chief Executive Officer,
stated, “The IEC meeting in Dublin provides us with another key
opportunity to connect with leading epileptologists and showcase
our XEN1101 Phase 3 epilepsy program, which includes our ongoing
X-TOLE2, X-TOLE3, and X-ACKT clinical trials in focal onset
seizures and primary generalized tonic-clonic seizures,
respectively. In addition, we presented interim data from the
ongoing open-label extension study from our Phase 2b X-TOLE trial,
showing the long-term efficacy of XEN1101 as demonstrated by
patients experiencing continued seizure reduction during the OLE
and extended periods of seizure freedom, which translates into
overall improvements in patients’ quality of life. These new data
related to quality-of-life improvements are consistent with the
compelling clinical results generated to date and contribute to the
growing evidence that support the promise of XEN1101 as a novel,
differentiated potential treatment for patients with epilepsy.”
An interim analysis (cutoff date September 22, 2022) of the
ongoing X-TOLE open-label extension (OLE) study demonstrated that
treatment with XEN1101 resulted in sustained monthly reduction in
seizure frequency from double-blind period (DBP) baseline, with
adverse events (AEs) consistent with previous results and those
seen with other antiseizure medications (ASMs), and no new safety
signals were identified.
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
Dr. Christopher Kenney, Xenon’s Chief Medical Officer, stated,
“As we continue to amass data from our ongoing open-label extension
study – with a cohort of patients now on drug for more than three
years – XEN1101 has continued to demonstrate its efficacy through
sustained seizure reduction. As a clinician, it is encouraging to
see these QoL data, such as the improvements seen across all
patients in Medication Effects, as this suggests that patients may
benefit from XEN1101, perceiving it to be efficacious and generally
well tolerated. Recognizing that there is a substantial need for
new, efficacious, and well-tolerated antiseizure medications, we
are excited to continue to advance the development of XEN1101
across multiple ongoing Phase 3 epilepsy studies.”
Summary of IEC 2023 Presentations and Poster
Sessions
On Sunday, September 3, 2023, Xenon hosted the following
presentations at IEC 2023:
-
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.
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 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 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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