Xenon Pharmaceuticals Announces Launch of XEN1101 Phase 3 Program with Initiation of X-TOLE2 Clinical Trial in Patients with Focal Onset Seizures
03 November 2022 - 11:30PM
Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neurology-focused
biopharmaceutical company, today announced the launch of its
XEN1101 Phase 3 program with the initiation of the X-TOLE2 clinical
trial, which will examine XEN1101 administered as an adjunctive
treatment for adult patients with focal epilepsy.
Mr. Ian Mortimer, Xenon’s President and Chief
Executive Officer, stated, “We are thrilled to announce the launch
of our XEN1101 Phase 3 program with the initiation of our X-TOLE2
clinical trial. We have ambitious clinical development plans for
XEN1101, including our X-TOLE2 and X-TOLE3 clinical trials in focal
onset seizures, as well as our Phase 3 X-ACKT clinical trial in
primary generalized tonic clonic seizures. We continue to hear from
key opinion leaders and prescribing physicians that novel
mechanisms are needed to provide new therapeutic options that are
clearly differentiated from the anti-seizure medications currently
available. Backed by a strong scientific rationale and compelling
Phase 2b clinical data, we are focused on advancing XEN1101 through
its late-stage clinical development towards commercialization, with
the goal of providing new therapies for epilepsy patients in
need.”
About XEN1101XEN1101 is a
differentiated Kv7 potassium channel opener being developed for the
treatment of epilepsy and major depressive disorder. In October
2021, Xenon announced positive results from its Phase 2b X-TOLE
clinical trial, which evaluated the clinical efficacy, safety and
tolerability of XEN1101 administered as an adjunctive treatment for
adult patients with focal epilepsy. In June 2022, Xenon announced
the successful completion of an End-of-Phase 2 meeting with the
U.S. Food & Drug Administration (FDA). Based on the EOP2
meeting, Xenon and the FDA aligned on key elements of the Phase 3
program to support a New Drug Application (NDA) submission. Xenon
plans to submit an NDA upon completion of the first XEN1101 Phase 3
clinical trial (X-TOLE2), if successful, and use the existing data
package from the Phase 2b X-TOLE clinical trial along with
additional safety data from other clinical trials to meet
regulatory requirements.
About the XEN1101 Phase 3
ProgramXenon has initiated its XEN1101 Phase 3 development
program, which includes two identical Phase 3 clinical trials to be
run in parallel, called X-TOLE2 and X-TOLE3, that are designed
closely after the Phase 2b X-TOLE clinical trial. These
multicenter, randomized, double-blind, placebo-controlled trials
will evaluate the clinical efficacy, safety, and tolerability of
XEN1101 administered as adjunctive treatment in approximately 360
patients per study with focal onset seizures (FOS). The primary
efficacy endpoint is the median percent change (MPC) in monthly
seizure frequency from baseline through the double-blind period
(DBP) of XEN1101 compared to placebo. On completion of the DBP in
X-TOLE2 and X-TOLE3, eligible patients may enter an open-label
extension (OLE) study for up to three years. In addition, the
ongoing X-TOLE OLE also continues to generate important long-term
data for XEN1101 in FOS. Xenon also intends to initiate 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 DBP of XEN1101 compared
to placebo. On completion of the DBP in X-ACKT, eligible patients
may enter an OLE study for up to three years.
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 XEN1101 and other 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 RegtsXenon
Pharmaceuticals Inc.Phone: 604.484.3353Email:
investors@xenon-pharma.com
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