Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neuroscience-focused
biopharmaceutical company dedicated to discovering, developing, and
delivering life-changing therapeutics for patients in need, today
announced three poster presentations at the 15th European Epilepsy
Congress (EEC) taking place in Rome, Italy. Azetukalner, a novel,
potent Kv7 channel opener, is the most advanced, clinically
validated potassium channel modulator in late-stage development for
multiple indications, including focal onset seizures (FOS), primary
generalized tonic-clonic seizures (PGTCS) and major depressive
disorder (MDD).
“We are excited for this opportunity to engage
with leading epileptologists at EEC in Rome and share long-term
azetukalner data from our ongoing X-TOLE open-label extension
study. Azetukalner represents the only Kv7 potassium channel opener
in clinical development that is supported by Phase 2b data as well
as long-term efficacy and safety data in epilepsy patients,” stated
Dr. Christopher Kenney, Chief Medical Officer of Xenon. “These data
are particularly impressive given the baseline disease severity,
with patients who are out to 30 months in the open-label extension
study showing a greater than 90% reduction in median monthly
seizure frequency, while approximately one in four patients on
azetukalner for at least two years in the OLE have experienced a
period of seizure freedom of a year or longer.”
Dr. Kenney continued, “We are also presenting
patient-reported survey data illustrating the substantial burden of
illness for people living with epilepsy, with reduced quality of
life, high seizure frequency and fatigue, as well as other
comorbidities such as anxiety and depression, further underscoring
the need for new medications to help people living with
epilepsy.”
Presentations at EEC:
Poster #P282: Azetukalner
(XEN1101), a Novel, Potent Kv7 Potassium Channel Opener: Interim
Data From an Ongoing, Long‑Term, Open‑Label Extension of a Phase 2b
Study (X‑TOLE) in Adults With Focal Onset
SeizuresPresenter: Jacqueline A. French, New York
University Grossman School of Medicine and NYU Langone Health, New
York, NYSession Times: Daily from 1:30-3:00 pm
CEST
Poster #P281: Long-term,
Quality of Life in Epilepsy Inventory-31 (QOLIE-31) Improvements in
Adults With Focal Onset Seizures Treated With Azetukalner (XEN1101)
in an Ongoing, Open-Label Extension of a Phase 2b study
(X-TOLE)Presenter: Christian Brandt, Bethel
Epilepsy Centre, Mara Hospital, University Hospital for
Epileptology, Bielefeld, GermanySession Times:
Daily from 1:30-3:00 pm CESTPoster Tour: S2
Clinical Neurophysiology/Drug Therapy
Poster #P406: Non-seizure
Symptoms, Mental Health Comorbidities, and Quality of Life in
Patients Reporting Focal Onset SeizuresPresenter:
Cynthia Harden, Xenon Pharmaceuticals Inc. Session
Times: Daily from 1:30-3:00 pm CEST
Posters will be available for viewing at the
conference from Sunday, September 8 until Tuesday, September 10 at
4:00 pm CEST and will be added to the Xenon website consistent with
conference guidelines. Xenon is also hosting a Scientific Exhibit
at location SE1 and Booth #346.
About Xenon Pharmaceuticals
Inc.Xenon Pharmaceuticals (Nasdaq:XENE) is a
neuroscience-focused biopharmaceutical company committed to
discovering, developing, and commercializing innovative
therapeutics to improve the lives of people living with
neurological and psychiatric disorders. We are advancing a novel
product pipeline to address areas of high unmet medical need,
including epilepsy and depression. Azetukalner, our lead Kv7
channel opener, represents the most advanced, clinically validated
potassium channel modulator in late-stage clinical development for
multiple indications. For more information, please visit
www.xenon-pharma.com.
About the Azetukalner Phase 3 Epilepsy
ProgramXenon’s Phase 3 epilepsy program includes three
ongoing Phase 3 clinical trials in focal onset seizures (FOS) and
primary generalized tonic-clonic seizures (PGTCS). Designed closely
after the Phase 2b X-TOLE clinical trial, the Phase 3 X-TOLE
clinical trials are multicenter, randomized, double-blind,
placebo-controlled studies evaluating the clinical efficacy,
safety, and tolerability of 15 mg or 25 mg of azetukalner
administered with food as adjunctive treatment in approximately 360
patients with FOS per study. The primary efficacy endpoint is the
median percent change (MPC) in monthly seizure frequency from
baseline through the double-blind period (DBP) of azetukalner
compared to placebo. X-ACKT is a multicenter, randomized,
double-blind, placebo-controlled study evaluating the clinical
efficacy, safety, and tolerability of 25 mg of azetukalner
administered with food as adjunctive treatment in approximately 160
patients with PGTCS. The primary efficacy endpoint is the MPC in
monthly PGTCS frequency from baseline through the DBP of
azetukalner compared to placebo.
Safe Harbor StatementThis 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 in current and anticipated
indications, 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 azetukalner and other pipeline and
development programs; and our ability to successfully develop and
obtain regulatory approval of azetukalner 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; 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 azetukalner, 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 market, industry, and regulatory
conditions on clinical trial enrollment; 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; as well as the other risks identified in our filings
with the U.S. 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.
Contacts: For Investors:Chad
FugereVice President, Investor Relations(857)
675-7275investors@xenon-pharma.com
For Media:Colleen AlabisoSenior Vice President,
Corporate Affairs(617) 671-9238media@xenon-pharma.com
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