Xenon’s innovative, proprietary epilepsy programs
continue to advance in development
Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a clinical-stage
biopharmaceutical company, today announced the initiation of a
Phase 1 “first-in-human” clinical trial of its proprietary epilepsy
product candidate, XEN1101, which is an orally administered Kv7
potassium channel opener that has the potential to treat both adult
as well as rare pediatric genetic forms of epilepsy. The Clinical
Trial Application (CTA) for XEN1101 was accepted by the Medicines
& Healthcare products Regulatory Agency (MHRA) in the United
Kingdom (UK), and the first subject has now been dosed in the Phase
1 clinical trial.
Dr. Simon Pimstone, Xenon’s President and Chief
Executive Officer, said, “The initiation of clinical development of
XEN1101 is a significant achievement and step forward for Xenon’s
proprietary epilepsy assets. We believe that XEN1101’s mechanism of
action represents a therapeutically differentiated alternative to
the currently available anti-epileptic medications and, based on
extensive pre-clinical work performed to date, may provide a better
safety and tolerability profile when compared to ezogabine, an
earlier generation potassium channel modulator that is no longer on
the market. In addition to safety and pharmacokinetics data, the
XEN1101 Phase 1 clinical trial has been designed to include a
pharmacodynamic read-out incorporating a transcranial magnetic
stimulation, or TMS, model, with data expected in the first quarter
of 2018. The TMS model is designed to demonstrate delivery of
XEN1101 into the central nervous system to observe a change in EEG
or EMG activity.”
Dr. Pimstone added, “I am excited that our
proprietary epilepsy products, which are clearly differentiated
from other currently available anti-epileptic products and those in
development, are now positioned to potentially meet some critical
clinical milestones over the coming months. In addition to
XEN1101, we are equally excited about the advancement of XEN901, a
unique selective sodium channel (Nav1.6) inhibitor for the
treatment of epilepsy, and expect to file an IND equivalent
application in the fourth quarter of this year. We believe that
XEN1101 and XEN901 are highly innovative and differentiated
anti-epileptic drug candidates with potentially broad applicability
to address larger patient populations, such as adult focal
seizures, as well as rare, genetically defined pediatric epilepsy
disorders caused by mutations in the channels that these drugs have
been designed to interact with.”
About XEN1101XEN1101 is a
neuronal Kv7 voltage-gated potassium channel opener and augments
the channel’s critical function of dampening neuronal excitability.
XEN1101 is being developed as a treatment for seizures by
stabilizing neuronal cell firing and reducing brain
hyperexcitability. The Kv7 potassium channel opener mechanism has
been clinically validated as an effective adjunctive treatment for
treatment-resistant focal onset seizures as demonstrated with
ezogabine, an earlier generation Kv7 opener. However, XEN1101’s
unique composition is chemically designed to improve upon potency,
selectivity, and pharmacokinetics, but it is not expected to have
ezogabine’s composition-specific skin and eye pigmentary
liabilities.
XEN1101 Phase 1 Clinical Trial
DesignThe XEN1101 Phase 1 clinical trial is a randomized,
double-blind, placebo-controlled study that will evaluate the
safety, tolerability and pharmacokinetics (PK) of both single
ascending doses (SAD) and multiple ascending doses (MAD) of XEN1101
in healthy subjects. In addition, the pharmacodynamic impact of
single doses of XEN1101 using TMS will be studied in parallel with
the SAD/MAD portions of this Phase 1 safety study. It is estimated
there will be approximately 64 subjects in the planned SAD and MAD
cohorts, with approximately 15 subjects taking part in the TMS
cross-over study. Following the completion of the Phase 1 clinical
trial and if supported by the data, it is anticipated that XEN1101
will advance into a Phase 2 proof-of-concept trial in the third
quarter of 2018 evaluating its efficacy as a treatment for adult
focal seizures, with a parallel plan to advance XEN1101 into rare,
pediatric forms of epilepsy as soon as feasible thereafter.
About Focal Seizures A focal
seizure is localized within the brain and can either stay localized
or spread to the whole brain, which is typically categorized as
secondary generalized seizures. Focal seizures are the most common
type of seizure experienced by people with epilepsy. The treatment
of an individual patient with focal seizures is currently focused
on reduction of seizure frequency, with seizure freedom as the
ultimate goal. Focal seizures (simple, complex and secondarily
generalized tonic-clonic) account for approximately 60% of seizures
(GlobalData Report 2013) of which approximately 33% are considered
resistant to current treatments (Epilepsy Foundation). It is
estimated that the addressable population in the U.S. for XEN1101
could include approximately 460,000 adults and 70,000 pediatric
epilepsy patients with refractory seizures.
Human Genetic Validation of KCNQ2:
XEN1101 as a Potential Treatment for Orphan Pediatric
Epilepsy The KCNQ2 gene codes for the Kv7.2 voltage-gated
potassium channel. Loss-of-function missense mutations in KCNQ2
cause an extremely severe single-gene epilepsy disorder
characterized by multiple, daily, treatment-resistant seizures
often presenting within the first week of life. This human genetic
validation further underpins the important role KCNQ2 plays in
limiting the hyperexcitatory state of the brain and as a target for
the prevention of seizures in humans. XEN1101, which directly opens
the Kv7.2 channel, represents a potential treatment of this
treatment-resistant, early infantile epileptic “KCNQ2”
encephalopathy, also categorized as EIEE7. In parallel with its
ongoing development plans to study XEN1101 in adults with focal
seizures in a Phase 2 proof-of-concept clinical trial, Xenon is
exploring the options around the regulatory pathways required
to study XEN1101 in pediatric patients with EIEE7.
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 timing of and
results from our clinical trials and pre-clinical development
activities related to XEN1101 and our other product candidates, the
potential efficacy, safety profile, future development plans,
addressable market, regulatory success and commercial potential of
XEN1101 and our other product candidates, the anticipated timing of
IND, or IND equivalent, submissions and the initiation of future
clinical trials for XEN1101 and our other product candidates, the
efficacy of our clinical trial designs, our ability to successfully
develop and achieve milestones in the XEN1101 and other development
programs, the anticipated benefits of XEN1101’s unique composition,
the design of our clinical trials and anticipated enrollment,
and the progress and potential of our other 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; our efforts to expand
our current pipeline, including through the advancement of XEN1101
into clinical development, may not be successful; 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;
the impact of expanded product development and clinical activities
on operating expenses; 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 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 VP, Corporate
Affairs & Investor Relations Xenon Pharmaceuticals Inc. Phone:
604.484.3353 Email: investors@xenon-pharma.com
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