Xenon Pharmaceuticals Announces Publication of Results from XEN1101 Phase 2b “X-TOLE” Clinical Trial in Peer-Reviewed Journal Article in JAMA Neurology
10 October 2023 - 7:15AM
Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neurology-focused
biopharmaceutical company, today announced the medical journal JAMA
Neurology has published peer-reviewed efficacy and safety results
from the X-TOLE Phase 2b randomized clinical trial of XEN1101, a
novel potassium channel opener, in adults with focal epilepsy.
Importantly, the efficacy and safety findings of this clinical
trial supported the further clinical development in epilepsy of
XEN1101, which is currently being evaluated in Phase 3 clinical
trials in patients with focal onset seizures (FOS) and primary
generalized tonic-clonic seizures.
Mr. Ian Mortimer, Xenon’s President and Chief Executive Officer,
stated, “We are pleased to report that the peer-reviewed results
from our Phase 2b X-TOLE study of XEN1101 in adults with focal
epilepsy have been published in the prestigious JAMA Neurology
journal. With a cohort of patients now on drug for more than four
years as we continue to gather data from our ongoing open-label
extension study, XEN1101 continues to demonstrate its efficacy
through sustained seizure reduction and a compelling product
profile with once-daily dosing with food and no titration required.
Based on the need for new, efficacious, and well-tolerated
antiseizure medications, we continue to advance the Phase 3
development of XEN1101 in our X-TOLE2, X-TOLE3 studies (in focal
onset seizures) and the X-ACKT study (in primary generalized
tonic-clonic seizures). We look forward to presenting additional
longer-term data from the X-TOLE open-label extension study at AES
2023, the upcoming annual meeting of the American Epilepsy Society
in December.”
In the XEN1101 Phase 2b X-TOLE study, the primary efficacy
endpoint was the median percent change from baseline in monthly FOS
frequency. Treatment-emergent adverse events (TEAEs) were recorded,
and comprehensive laboratory assessments were made. A total of 325
patients who were randomized and treated were included in the
safety analysis; 285 completed the 8-week double-blind phase. In
the 325 patients included, mean (SD) age was 40.8 (13.3) years, 168
(51.7%) were female, and 298 (91.7%) identified their race as
White. Treatment with XEN1101 was associated with seizure reduction
in a robust dose-response manner. The median (IQR) percent
reduction from baseline in monthly FOS frequency was 52.8% (P <
.001 vs placebo; IQR, −80.4% to −16.9%) for 25 mg, 46.4% (P <
.001 vs placebo; IQR, −76.7% to −14.0%) for 20 mg, and 33.2% (P =
.04 vs placebo; IQR, −61.8% to 0.0%) for 10 mg, compared with 18.2%
(IQR, −37.3% to 7.0%) for placebo. XEN1101 was generally well
tolerated and TEAEs were similar to those of commonly prescribed
ASMs, and no TEAEs leading to death were reported.
The article entitled “Efficacy and Safety of XEN1101, a Novel
Potassium Channel Opener, in Adults With Focal Epilepsy A Phase 2b
Randomized Clinical Trial” was posted today on the JAMA Neurology
website.
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
potential efficacy, safety profile, future development plans,
addressable market, regulatory success and commercial potential of
XEN1101; the efficacy of our clinical trial designs; our ability to
successfully develop and achieve milestones in our XEN1101
development program; our intention to publish data from the ongoing
open-label extension study, and our ability to successfully develop
and obtain regulatory approval of XEN1101. 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 pandemics, epidemics
and other public health crises 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; 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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