Phase 1 expected to begin in Q4 2017, with
pharmacodynamic read-out in Q1 2018 and Phase 2
proof-of-concept clinical trial beginning in mid-2018
Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a clinical-stage
biopharmaceutical company, today reported the expansion of its ion
channel, neurology-focused product pipeline with XEN1101, an
innovative potassium channel modulator for the potential treatment
of epilepsy. Xenon acquired worldwide development and
commercialization rights to XEN1101 from 1st Order Pharmaceuticals,
Inc. XEN1101 is a next-generation Kv7 potassium channel opener that
preclinically demonstrated improved pharmacokinetics, selectivity,
and pharmacology from a new chemical platform over first-generation
potassium channel modulators, such as ezogabine. Xenon anticipates
filing an IND, or IND equivalent, to initiate a Phase 1
first-in-man clinical trial in the fourth quarter of 2017.
Dr. Simon Pimstone, Xenon’s President and Chief
Executive Officer, said, “We believe we have unique expertise to
evaluate modulators of ion channel targets with strong human
genetic validation, such as XEN1101. Our small molecule ion channel
capabilities enable us to identify and develop selective and
differentiated modulators of these targets. Consistent with our
goal of building a diverse, neurology-focused portfolio of ion
channel modulators, we have assessed numerous compounds being
developed externally to complement our own internal discovery
efforts.”
Dr. Pimstone added, “Based on its mechanism of
action, XEN1101 potentially represents a therapeutically
differentiated alternative to the anti-epileptic medications
currently available and could provide a better safety and
tolerability profile when compared with earlier generation
potassium channel modulators. We anticipate that XEN1101 will be in
a Phase 1 clinical trial in the fourth quarter of 2017. Early
clinical development is expected to include a pharmacodynamic
read-out in the first quarter of 2018 and Phase 2 development
beginning by mid-2018.”
About XEN1101XEN1101 acts as a
neuronal Kv7 voltage-gated potassium channel opener, which has been
developed to stabilize nerve cells, control action potential burst
firing, and reduce brain hyperexcitability as a treatment for
seizures. This mechanism has proven clinical efficacy in epilepsy
as shown with ezogabine, the first generation Kv7 opener. Ezogabine
demonstrated that a Kv7 potassium channel opener mechanism is an
effective adjunctive treatment for treatment-resistant focal, or
partial onset, seizures, which led to its market approval in Europe
and the U.S. XEN1101’s unique composition is chemically designed to
improve upon the potency, selectivity, and pharmacokinetics of
first generation molecules that have validated Kv7 as an epilepsy
target, but it is not expected to have the composition-specific
liabilities that have been implicated with earlier generation
drugs. Ezogabine is expected to be discontinued and will no longer
be commercially available past June 2017.
Human Genetic Validation of
KCNQ2The KCNQ2 gene codes for the Kv7.2 voltage gated
potassium channel. Loss of function missense mutations in KCNQ2
cause an extreme single-gene epilepsy disorder characterized by
multiple, daily, treatment-resistant seizures 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 prevention of seizures in humans. XEN1101
could represent a potential treatment of this rare, severe,
treatment-resistant, early infantile epileptic “KCNQ2”
encephalopathy, also categorized as EIEE7.
Clinical Development of
XEN1101XEN1101 will initially be developed for
treatment-resistant focal, or partial onset, seizures in adults, a
strategy supported by the clinical validation of the target with
ezogabine. XEN1101 has completed GLP safety pharmacology and
toxicology studies, along with a pre-IND meeting with the FDA. It
is anticipated that an IND, or IND equivalent, will be filed to
initiate a Phase 1 clinical trial in the fourth quarter of 2017.
Early clinical development is expected to include a pharmacodynamic
read-out in the first quarter of 2018 and Phase 2 development
beginning in mid-2018.
XEN1101 Deal Terms XEN1101
(previously known as 1OP2198) was acquired from 1st Order
Pharmaceuticals, Inc. pursuant to an asset purchase
agreement. 1st Order previously acquired 1OP2198 (previously
known as VRX621698) from a third party, and Xenon will assume
certain financial responsibilities under that agreement. Near term
upfront and milestone consideration to be paid in 2017 is expected
to total approximately $1.1 million. Future potential payments to
both 1st Order and the third party include $1 million in clinical
development milestones, up to $13 million in regulatory milestones,
and up to approximately $33.6 million in sales-based and other
milestones, which includes a $1.5 million milestone that may be
payable pre-commercially, plus a mid-to-high single digit
percentage royalty on commercial sales.
Mr. Christopher Crean, 1st Order
Pharmaceuticals’ Cofounder, President and Chief Science Officer,
said, “Having been involved in the final development and approval
of ezogabine, I am pleased to see Xenon move ahead with XEN1101, a
promising ‘next-generation’ therapeutic based on a proven
mechanism. I have spent a considerable part of my career in the
development of potassium channel openers, and with Xenon’s focus on
neurology and ion channel modulators, I am hopeful that the
advancement of XEN1101 will ultimately lead to a new treatment
option for patients with epilepsy.”
About Focal (Partial Onset)
Seizures A focal, or partial onset, 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 total addressable population for XEN1101 could
include approximately 460,000 adults and 70,000 pediatric epilepsy
patients.
Conference Call Information
Xenon will host a conference call and live audio
webcast today at 9:00 a.m. Eastern Time (6:00 a.m. Pacific Time) to
discuss its XEN1101 program. To participate in the call, please
dial (855) 779-9075, or (631) 485-4866 for international callers,
and provide conference ID number 14014831. The webcast will be
broadcast live on the “Investors” section of Xenon's website
at www.xenon-pharma.com and will be available for replay
following the call for 30 days.
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 include
statements regarding the anticipated timing of the IND, or IND
equivalent, submission for XEN1101 and the initiation of clinical
trials for XEN1101, our ability to successfully develop and achieve
milestones in the XEN1101 program, the timing of and results from
our clinical trials and pre-clinical development activities related
to XEN1101, the potential efficacy, safety profile, future
development plans, addressable market, regulatory success and
commercial potential of XEN1101, the anticipated discontinuation of
the commercial availability of ezogabine, the amounts and timing of
anticipated milestone payments and royalties potentially owing to
1st Order and the associated third party, 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 acquisition of XEN1101, 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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