Xenon Pharmaceuticals Provides Updates on Neurology Pipeline Programs at the Annual Meeting of the American Epilepsy Society (AES 2023)
December 02 2023 - 12:01PM
Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neurology-focused
biopharmaceutical company, today announced it will provide updates
on its neurology programs at the Annual Meeting of the American
Epilepsy Society (AES 2023).
Mr. Ian Mortimer, Xenon’s President and Chief Executive Officer,
stated, “Xenon will have another strong presence at AES this year,
with many presentations and activities aimed at raising awareness
about our XEN1101 program with the epileptologists and neurologists
in attendance. Importantly, we are looking forward to presenting
new interim data from our ongoing open-label extension study from
our Phase 2b X-TOLE trial. These new data demonstrate impressive
seizure freedom rates, including almost one in four patients who
were on treatment for at least two years achieving at least 12
months of consecutive seizure freedom. In addition, we have now
generated more than 500 patient years of safety data through our
open label study, continuing to build on the significant body of
evidence to support XEN1101’s safety and tolerability profile.”
Mr. Mortimer continued, “In addition, at our Xenon-sponsored
scientific exhibit, we will present survey results on general
burden of illness, quality of life, and mental health burden of
illness from patients reporting focal onset seizures, which suggest
that depression and anxiety, common comorbidities in epilepsy,
further exacerbate the burden of epilepsy and may require
additional care or support. Also at our scientific exhibit, we will
feature a summary of the promising topline data from our XEN1101
Phase 2 X-NOVA study in major depressive disorder, or MDD, that we
released earlier this week, and we look forward to engaging with
the neurology community on these important data.”
AES XEN1101 Poster Highlights
Poster No. 1.277 (French et al.) “Interim Long-Term Safety and
Efficacy of XEN1101, a Potent, Selective Potassium Channel Opener:
Update From an Ongoing, Open-Label Extension of a Phase 2b Study
(X-TOLE) in Adults With Focal Epilepsy”
- Once daily (QD) dosing of 20 mg of
XEN1101 with food yielded long-term efficacy in this interim
analysis with 60% retention at 24 months.
- During open-label extension (OLE)
study months 18 to 30, there was a sustained monthly reduction in
seizure frequency (78%–95% median percent change) from double-blind
period baseline, and higher reductions were observed for patients
who were receiving one to two anti-seizure medications (ASMs) at
baseline compared to those receiving three ASMs.
- Seizure freedom for ≥3-month,
≥6-month, and ≥12-month consecutive durations was achieved in
37.5%, 22.2%, and 14.9% of all patients enrolled in the OLE
(n=275), respectively.
- Seizure freedom for ≥3-month,
≥6-month, and ≥12-month consecutive durations was achieved in
56.4%, 34.5% and 23.6% of those patients with at least 24 months of
treatment in the OLE (n=165), respectively.
- XEN1101 continues to be generally
well-tolerated in the OLE with adverse events (AEs) consistent with
prior results and other AEs seen with other anti-seizure
medications; no new safety signals were identified.
Poster No. 2.260 (Brandt et al.) “Long-Term Quality-of-Life
Improvements in Adults With Focal Onset Seizures Treated With
XEN1101 in an Ongoing Open-Label Extension of a Phase 2b Study
(X-TOLE)”
- Clinically important improvements in
the Quality of Life in Epilepsy Inventory-31 (QOLIE-31) subscales
of Seizure Worry, Social Functioning, and Medication Effects were
seen across all patients, with even greater improvements in the
seizure-free group (SFG).
- The SFG achieved clinically
important improvements in all quality-of-life domains assessed by
the QOLIE-31 except for Energy/Fatigue.
- The improvements in Medication
Effects across all patients is notable as this documented improved
drug tolerability accompanied long-term seizure reduction in a
difficult-to-treat epilepsy patient population.
- The rapid marked improvements seen
in Medication Effects, Seizure Worry, and Social Functioning in the
SFG over the first 3 months of the OLE were sustained and continued
to improve over the first 2 years of the OLE.
- Quality-of-life improvements, as
measured by the QOLIE-31, originally reported at year 1 were
maintained or improved at year 2 of the X-TOLE OLE.
Poster No. 2.259 (Porter et al.) “The Impact of Disease Severity
on Responder Rates in a Phase 2b Study of XEN1101, a Potent,
Selective Potassium Channel Opener, in Adults With Focal Epilepsy
(X-TOLE)”
- Consistent with the significant MPC
reduction in X-TOLE, 54.5% of the patients in the 25 mg group
achieved the benchmark of RR50, which is the percentage of patients
with a >50% reduction in seizure frequency during a given
treatment period compared with baseline.
- This effect was observed in a
difficult-to-treat patient population.
- XEN1101 was relatively more
effective in patients with indicators of less-severe disease in the
trial population.
Other Posters and Exhibits
Xenon is also presenting pre-clinical work from its discovery
efforts related to the exploration of Nav1.1 potentiators for the
treatment of Dravet Syndrome:
- Poster No. 2.247 (Goodchild et al.)
“A Selective Nav1.1 Potentiator Enhances Interneuron Excitability
to Normalize Motor Performance in a Dravet Syndrome Mouse
Model”
Scientific Exhibit
Xenon is hosting a scientific exhibit at AES 2023 providing an
overview of its clinical and research programs on Sunday, December
3, 2023 from 2-5 pm ET in Room w315B, Level 3 of the Orange County
Convention Center in Orlando, FL. In addition to the posters noted
above, the exhibit will provide information related to the XEN1101
Phase 3 epilepsy program, including the X-TOLE2 and X-TOLE3
clinical trials in focal onset seizures and X-ACKT clinical trial
in primary generalized tonic-clonic seizures. The exhibit will also
feature the topline results from the Phase 2 proof-of-concept
X-NOVA clinical trial in major depressive disorder. Other poster
presentations will cover results from two Xenon-sponsored
web-enabled surveys using validated patient-reported outcome
measures to assess the general burden of illness, quality of life,
and mental health burden of illness in patients reporting focal
onset seizures.
Exhibit Hall Booth
Xenon is also hosting a booth (#502) in the Exhibit Hall, which
is scheduled to open at 12 pm ET on Saturday, December 2, 2023 and
close on Monday, December 4, 2023 at 2 pm ET.
Posters will be added to the Xenon website consistent with AES
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 results from clinical trials; the potential efficacy,
safety profile, future development plans, addressable market,
regulatory success and commercial potential of 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 successfully develop
and obtain regulatory approval of XEN1101 and our other product
candidates. These forward-looking statements are based on current
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that may cause the actual results, events, or developments to be
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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
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Investor/Media Contact:Jodi RegtsXenon
Pharmaceuticals Inc.Phone: 604.484.3353Email:
investors@xenon-pharma.com
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