Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neurology-focused
biopharmaceutical company, today outlined recent progress in its
clinical programs and key milestones for 2023.
Mr. Ian Mortimer, Xenon’s President and Chief
Executive Officer, stated, “We enter 2023 in a strong position with
increasing momentum in our XEN1101 Phase 3 program, which
represents the most advanced potassium channel modulator in
clinical development for multiple indications. With our X-TOLE2
study underway in focal onset seizures, we are excited to announce
the initiation of our Phase 3 X-ACKT clinical trial in primary
generalized tonic clonic seizures.”
Mr. Mortimer continued, “We believe XEN1101
shows immense promise based on its validated mechanism of action
and a robust data package, including efficacy data from our Phase
2b X-TOLE clinical trial and read-outs from our ongoing open-label
extension study. Having established alignment with the FDA on our
Phase 3 program and NDA filing requirements, we remain sharply
focused on advancing XEN1101 with the goal of improving outcomes
for epilepsy patients where there continues to be a significant
need for new, differentiated anti-seizure medications.”
Mr. Mortimer added, “In parallel with the work
supporting the continued advancements of our Phase 3 XEN1101
program, we also anticipate clinical data read-outs in 2023. In the
third quarter of this year, we expect the topline data readout from
our Phase 2 X-NOVA clinical trial, a proof-of-concept study
examining the use of XEN1101 in major depressive disorder. In
addition, our partners at Neurocrine expect to have a clinical
read-out from their Phase 2 study in adult patients with focal
onset seizures in the second half of this year.”
Highlights and Anticipated
Milestones
XEN1101XEN1101 is a
differentiated Kv7 potassium channel opener being developed for the
treatment of epilepsy and major depressive disorder (MDD).
XEN1101 for Focal Onset
SeizuresXenon 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.
XEN1101 for Primary Generalized Tonic
Clonic Seizures Xenon has initiated 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.
Upon completion of the DBP in X-TOLE2, X-TOLE3,
or X-ACKT, eligible patients may enter an open-label extension
(OLE) study for up to three years. In addition, the ongoing X-TOLE
Phase 2b OLE continues to generate important long-term data for
XEN1101.
XEN1101 for Major Depressive
DisorderBased on promising pre-clinical data with XEN1101
and published clinical data generated using ezogabine, Xenon is
evaluating the clinical efficacy, safety and tolerability of
XEN1101 administered as monotherapy in approximately 150 patients
with MDD in a Phase 2 clinical trial called X-NOVA. Designed as a
randomized, double-blind, placebo-controlled, multicenter clinical
study, the primary objective is to assess the efficacy of XEN1101
compared to placebo on improvement of depressive symptoms in
subjects diagnosed with moderate to severe MDD, using the
Montgomery-Åsberg Depression Rating Scale (MADRS) score change
through week six. Topline results from the X-NOVA study are
anticipated in the third quarter of this year.
In addition, Xenon is collaborating with the
Icahn School of Medicine at Mount Sinai to support an ongoing
investigator-sponsored Phase 2 proof-of-concept, randomized,
parallel-arm, placebo-controlled multi-site study of XEN1101 for
the treatment of MDD in approximately 60 subjects. The primary
objective of the study is to investigate the effect of XEN1101 on
the brain reward circuit as measured by the change in bilateral
ventral striatum activity as assessed by functional MRI (fMRI). The
secondary objectives are to test the effect of XEN1101 compared to
placebo on clinical measures of depression and anhedonia using the
MADRS and Snaith-Hamilton Pleasure Scale (SHAPS).
Additional Programs and Corporate
Updates
XEN496XEN496, a Kv7 potassium
channel opener, is a proprietary pediatric formulation of the
active ingredient ezogabine being developed for the treatment of
KCNQ2 developmental and epileptic encephalopathy (KCNQ2-DEE). A
Phase 3 randomized, double-blind, placebo-controlled, parallel
group, multicenter clinical trial, called EPIK, is ongoing to
evaluate the efficacy, safety, and tolerability of XEN496
administered as adjunctive treatment in approximately 40 pediatric
patients aged one month to less than six years with KCNQ2-DEE.
Xenon anticipates that the EPIK study will be completed in
2024.
NBI-921352Xenon has an ongoing
collaboration with Neurocrine Biosciences to develop treatments for
epilepsy. Neurocrine Biosciences has an exclusive license to
XEN901, now known as NBI-921352, a selective Nav1.6 sodium channel
inhibitor. Neurocrine Biosciences is conducting a Phase 2 clinical
trial evaluating NBI-921352 in adult patients with focal onset
seizures, with data expected in the second half of this year. In
addition, a Phase 2 clinical trial is underway evaluating
NBI-921352 in patients aged between 2 and 21 years with SCN8A
developmental and epileptic encephalopathy (SCN8A-DEE). Pursuant to
the terms of the agreement, Xenon has the potential to receive
certain clinical, regulatory, and commercial milestone payments, as
well as future sales royalties.
Cash and cash equivalents and marketable
securities were $752.2 million as of September 30, 2022. As
previously reported and based on current assumptions, which include
supporting the XEN1101 clinical development program including the
completion of the planned Phase 3 epilepsy studies, XEN496, and
pre-clinical and discovery programs, Xenon anticipates having
sufficient cash to fund operations into 2026, excluding any revenue
generated from existing partnerships or potential new partnering
arrangements.
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; anticipated enrollment in
our clinical trials and the timing thereof; and our expectation
that we will have sufficient cash to fund operations into 2026.
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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