Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neurology-focused
biopharmaceutical company, today announced it will provide updates
on its proprietary, neurology programs at the Annual Meeting of the
American Epilepsy Society (AES 2022). In addition, the Company is
presenting results from the open label extension (OLE) and
sub-analyses of data from the XEN1101 Phase 2b X-TOLE clinical
trial.
Mr. Ian Mortimer, Xenon’s President and Chief
Executive Officer stated, “We continue to advance our portfolio of
neurology-focused programs. Xenon will have a significant presence
at AES this year with seven poster presentations and a scientific
exhibit showcasing our recently launched XEN1101 Phase 3 program
and our planned clinical trials in focal onset seizures and primary
generalized tonic clonic seizures. We also look forward to meeting
with leading epileptologists, including Xenon trial investigators,
as well as patient advocacy groups at this important meeting.”
Mr. Mortimer continued, “Importantly, we have a
scientific poster outlining additional data from the open-label
extension of the XEN1101 Phase 2b X-TOLE study. This interim
analysis shows XEN1101 continues to be generally well-tolerated,
yielding long-term efficacy at the 20 mg once-daily dose, with
patients experiencing continued seizure reduction during the OLE
and extended periods of seizure freedom. Two other XEN1101-related
posters outline additional sub-analyses of the X-TOLE data that
suggest a rapid onset of efficacy of XEN1101, with statistically
significant reduction in focal onset seizures within one week for
all doses studied when compared to placebo. Further, based on the
number of concomitant ASMs, baseline seizure frequency, and number
of failed anti-seizure medications, the X-TOLE study enrolled more
‘difficult-to-treat’ patients than other similar focal onset
seizure studies. We believe this is important as it suggests that
the efficacy of XEN1101 may be robust in patients with less severe
disease, which may represent the most common use of XEN1101 if
commercially approved. With these promising data, we have now
initiated our XEN1101 Phase 3 program, where we hope to confirm
these encouraging results and continue to execute on our goal to
deliver a new, differentiated therapeutic that could potentially
play a key role in treating patients with epilepsy.”
XEN1101 AES Poster
Highlights
Poster No. 2.235 (French et al.)
“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”
- During the OLE, there was a
sustained monthly reduction in seizure frequency (80%–90% seizure
reduction as measured by MPC) from the double-blind period (DBP)
baseline, as of the analysis cutoff date of September 22,
2022.
- 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 (AEs) consistent with
prior results and other anti-seizure medications (ASMs).
- At the end of the first year in the OLE, patients recorded a
mean (SD) weight gain of 1.1 (5.9) kg.
- To date, two AEs of urinary retention occurred in the OLE
possibly related to study drug; both patients continued in the
study without requiring intervention.
- Although not seen to date, Xenon continues to monitor for the
emergence of the tissue discoloration that was associated with
long-term exposure to ezogabine.
Poster No. 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 Study
(X-TOLE)”
- X-TOLE met the primary and key secondary efficacy endpoints
with XEN1101 demonstrating a statistically significant,
dose-dependent reduction from baseline in monthly focal onset
seizure (FOS) frequency compared to placebo.
- The rapid onset of efficacy for XEN1101 was associated with
starting at an effective, therapeutic and well-tolerated dose.
There was a statistically significant reduction in median FOS
frequency within 1 week for all doses compared with placebo.
- The rapid onset of efficacy after 1 week and sustained efficacy
of XEN1101, if confirmed in the Phase 3 clinical trials, suggests
that XEN1101 may offer a compelling option for patients seeking
adjunctive therapy.
Poster No. 2.233 (Leung et al.) “The
Impact of Disease Severity on Efficacy From a Phase 2b Study of
XEN1101, a Novel Potassium Channel Opener, in Adults With Focal
Epilepsy (X-TOLE)”
- X-TOLE met the primary and key
secondary efficacy endpoints with XEN1101 demonstrating a
statistically significant, dose-dependent reduction from baseline
in monthly FOS frequency compared to placebo in a
difficult-to-treat population.
- 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 reduced seizure
frequency in sub-groups of patients with ≤ 8.5 seizures/month, and
in patients that failed ≤ 6 ASMs or were on 1-2 concomitant ASMs by
70.6%, 58.0% and 60.9%, respectively, compared with placebo (18.8%,
20.0% and 14.2%, respectively).
- These post hoc analyses suggest
that efficacy may be more robust in patients with less severe
disease, which may represent the most common clinical use of
XEN1101 if commercially approved.
Xenon’s Scientific Exhibit and
Booth
In addition to the posters noted above, Xenon is
hosting a scientific exhibit at AES 2022 providing an overview of
its clinical and research programs on Sunday, December 4, 2022 from
2-5 pm CT in Room 207 C, Level 2 of Music City Center. The exhibit
will feature an overview of the XEN1101 Phase 3 trial designs,
including X-TOLE2 and X-TOLE3 for FOS and X-ACKT for primary
generalized tonic clonic seizures, as well as the Phase 2 study
design for X-NOVA for major depressive disorder. Other poster
presentations will cover additional programs within Xenon’s
neurology-focused pipeline.
Xenon is also hosting a booth (#1028) in the
Exhibit Hall, which is scheduled to open at 12 pm CT on Saturday,
December 3, 2022 and run to 2 pm CT on Monday, December 5,
2022.
Other AES Poster Highlights
Other Xenon posters at AES 2022 include clinical
work related to Xenon’s XEN496 program and its ongoing Phase 3 EPIK
clinical trial in pediatric patients with KCNQ2 developmental and
epileptic encephalopathy:
- Poster 1.370 (Grayson et al.)
“Genetic Burden of KCNQ2 in Neonates With Epilepsy”
- Poster 1.372 (Harden et al.) “An
Online Survey of Caregivers of Patients With KCNQ2 Developmental
and Epileptic Encephalopathy”
- Poster 2.334 (Butterfield et al.)
“Real-World Evidence of KCNQ2 Disease Management as Generated
Through a Novel Data Platform”
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 3.049 (Goodchild et al.)
“Molecularly Selective NaV1.1 Potentiators Increase PV+
Fast-Spiking Interneuron Excitability and Restore Motor Performance
in a Mouse Model of Dravet Syndrome”
Posters will be added to the Xenon website
consistent with AES 2022 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 timing of and potential results from clinical trials;
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 development programs; the timing and
results of our interactions with regulators; our ability to
successfully develop and obtain regulatory approval of XEN1101 and
our other product candidates; and anticipated enrollment in our
clinical trials and the timing thereof. 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 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 the COVID-19 pandemic on our business; 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
Regts Xenon Pharmaceuticals Inc. Phone: 604.484.3353 Email:
investors@xenon-pharma.com
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