Positive Preclinical Data from Xenon’s XEN901 Epilepsy Program to be Presented at the 71st American Epilepsy Society Annual...
December 04 2017 - 4:01PM
Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical-stage
biopharmaceutical company, today announced the presentation of a
scientific poster entitled “Selective Inhibitors Suggest Nav1.6
Activity is the Primary Driver of Efficacy for Voltage-Gated Sodium
Channel Targeted AEDs” at the 71st American Epilepsy Society (AES)
Annual Meeting in Washington, D.C.
XEN901 is a potent, selective Nav1.6 sodium
channel inhibitor being developed by Xenon for the treatment of
epilepsy, including treatment resistant adult focal seizures and
rare, pediatric forms of epilepsy, such as EIEE13, an early
infantile epileptic encephalopathy associated with mutations in the
SCN8A gene and gain-of-function in the Nav1.6 sodium channel.
Dr. Simon Pimstone, Xenon's President and Chief
Executive Officer, said, “Non-selective sodium channel blockers,
such as phenytoin, carbamazepine, lacosamide, and lamotrigine, have
been the mainstay of treatment of patients with focal seizures for
decades. However, these non-selective sodium channel blockers also
inhibit other channels, leading to well recognized side effects
associated with their use, limiting dose titration required to
achieve maximal efficacy. With XEN901, we believe we have developed
the first highly selective blocker of Nav1.6, the most abundantly
expressed sodium channel in the neuroexcitatory pathways in the
central nervous system. We anticipate that our approach with XEN901
to selectively inhibit the Nav1.6 channel has the opportunity to
provide robust clinical efficacy along with an improved safety
profile.”
Xenon has examined XEN901 in preclinical models
of both genetically defined and more general types of epilepsy.
These studies showed that XEN901 demonstrated efficacy against
seizures in both the MES model, which is designed to be predictive
of adult focal seizures and an SCN8A Nav1.6 genetic
gain-of-function model, which is designed to be predictive of the
pediatric genetic epilepsy EIEE13. When compared to phenytoin in
the SCN8A model, XEN901 achieved the same degree of efficacy as
phenytoin at one thousand fold lower brain exposures.
Xenon expects to file an investigational new
drug equivalent application in the fourth quarter of 2017 in order
to initiate clinical development for XEN901 and, if supported by
the data, expects to initiate a Phase 2 clinical trial in late
2018.
About Xenon Pharmaceuticals
Inc.
Xenon is a clinical stage biopharmaceutical
company focused on developing innovative therapeutics to improve
the lives of patients with neurological disorders. Building upon
our extensive knowledge of human genetics and diseases caused by
mutations in ion channels, known as channelopathies, we are
advancing – both independently and with our pharmaceutical
collaborators – a novel product pipeline of ion channel modulators
to address therapeutic areas of high unmet medical need, such as
pain and 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 and Section 21E of the Securities Exchange Act of 1934 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 anticipated
timing of IND or IND equivalent submissions with regulatory
agencies, the initiation of future clinical trials, the timing of
and results from our and our collaborators’ ongoing clinical trials
and pre-clinical development activities, the potential efficacy,
future development plans and commercial potential of our and our
collaborators’ product candidates, including XEN901, and the
progress and potential of ongoing development programs. 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; any of our or our collaborators' product
candidates may fail in development, may not receive required
regulatory approvals, or may be delayed to a point where they are
not commercially viable; the impact of competition; adverse
conditions in the general domestic and global economic markets; 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
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trademarks or trademarks of Xenon Pharmaceuticals Inc. in various
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owner.
Investor/Media Contact:Jodi Regts VP, Corporate
Affairs & Investor Relations Xenon Pharmaceuticals Inc. Phone:
604.484.3353 Email: investors@xenon-pharma.com
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