Xenon Pharmaceuticals Outlines Key Milestone Opportunities for 2020 and Provides Corporate Update
January 13 2020 - 8:30AM
Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a clinical stage
biopharmaceutical company, today provided a corporate update and
outlined its key milestone opportunities for 2020.
Dr. Simon Pimstone, Xenon’s Chief Executive
Officer, said, “Xenon is entering 2020 in a very strong position
with an exciting portfolio of proprietary neurology-focused
candidates in clinical development, a healthy balance sheet, and
valued collaborators advancing partnered programs. We expect to
have multiple mid to late stage clinical trials underway in 2020
putting us in a position to generate important clinical data in
2020.”
Dr. Pimstone continued, “We anticipate a number
of important milestone events in 2020, including the initiation of
a Phase 3 clinical trial with XEN496 in patients with KCNQ2-DEE, a
severe and rare form of pediatric epilepsy. In addition to the
ongoing XEN1101 Phase 2b clinical trial in adult focal epilepsy,
where we anticipate top-line data later this year, we are also
seeking to expand the clinical development of XEN1101 in 2020 as we
evaluate additional potential clinical indications for this novel
Kv7 potassium channel modulator. Additionally, we look forward to
the results from a physician-led Phase 2 study examining XEN007 in
treatment-resistant childhood absence epilepsy.”
Dr. Pimstone added, “We are also fortunate to
work with great collaborators who continue to advance our partnered
programs. Neurocrine has guided that it expects to file an IND in
mid-2020 in order to start a Phase 2 clinical trial for XEN901 (now
known as NBI-921352) in SCN8A-DEE pediatric patients. Flexion
continues to develop its pre-clinical FX301 program focused on
peripheral nerve block for control of post-operative pain, and
anticipates initiating FX301 clinical trials in 2021.”
Anticipated Milestones
Proprietary Programs
- XEN1101 is a differentiated Kv7
potassium channel modulator being developed for the treatment of
epilepsy and potentially other neurological disorders. A Phase 2b
double-blind, placebo-controlled, multicenter clinical trial
(called the X-TOLE study) is underway to evaluate the clinical
efficacy, safety and tolerability of XEN1101 administered as
adjunctive treatment in approximately 300 adult patients with focal
epilepsy. The primary endpoint is the median percent change in
monthly focal seizure frequency from baseline compared to treatment
period of active versus placebo. Patient enrollment for this
XEN1101 Phase 2b clinical trial is ongoing in the United States,
Canada and Europe. Long term six-and nine-month toxicology studies
have now been completed, providing support for the 12-month open
label extension for patients enrolled in the Phase 2b clinical
trial. Depending upon the rate of enrollment, top-line results are
anticipated in the second half of 2020. Xenon continues to explore
the development of XEN1101 in other neurological
indications.
- XEN496 (active ingredient
ezogabine) is a Kv7 potassium channel modulator being developed by
Xenon. The U.S. Food and Drug Administration (FDA) has granted
orphan drug designation (ODD) for XEN496 as a treatment of KCNQ2
developmental and epileptic encephalopathy (KCNQ2-DEE). A
pharmacokinetic (PK) study testing Xenon’s proprietary pediatric
formulation of ezogabine (XEN496) in healthy adult volunteers is
expected to complete in the first quarter of 2020. The FDA
previously indicated that it is acceptable to study XEN496 in
infants and children up to four years old, and that a single, small
pivotal trial may be considered adequate in order to demonstrate
XEN496’s efficacy in KCNQ2-DEE, provided the study shows evidence
of a clinically meaningful benefit in patients with the intended
indication. After completion of the XEN496 PK study and discussions
with the FDA on a Phase 3 clinical trial design in the first
quarter of 2020, Xenon expects to initiate a Phase 3 clinical trial
in KCNQ2-DEE.
- XEN007 (active ingredient
flunarizine) is a CNS-acting calcium channel modulator that
modulates Cav2.1 and T-type calcium channels. Other reported
mechanisms include dopamine, histamine and serotonin inhibition. A
physician-led, Phase 2 proof-of-concept study has recently been
initiated to examine the potential clinical efficacy, safety, and
tolerability of XEN007 as an adjunctive treatment in pediatric
patients diagnosed with treatment-resistant childhood absence
epilepsy. Results from this Phase 2 investigator-led
proof-of-concept study are expected in 2020. Depending on the
results from the study, CAE may represent a potential orphan
indication for future development of XEN007.
Partnered Programs
- In December 2019, Xenon entered
into a license and collaboration agreement with Neurocrine
Biosciences, Inc. (Nasdaq:NBIX) to develop first-in-class
treatments for epilepsy. Neurocrine Biosciences has an exclusive
license to XEN901, now known as NBI-921352, a clinical stage
selective Nav1.6 sodium channel inhibitor for epilepsy. In
addition, Neurocrine Biosciences gained an exclusive license to
pre-clinical compounds for development, including selective Nav1.6
inhibitors and dual Nav1.2/1.6 inhibitors. The agreement also
included a multi-year research collaboration to discover, identify
and develop additional novel Nav1.6 and Nav1.2/1.6 inhibitors.
Neurocrine Biosciences anticipates filing an IND application with
the FDA in mid-2020 in order to start a Phase 2 clinical trial in
SCN8A developmental and epileptic encephalopathy patients in the
second half of 2020. Xenon is eligible to receive up to $25 million
upon the FDA acceptance of an IND for NBI-921352, with 55% of the
amount in the form of an equity investment in Xenon at a 15%
premium to Xenon's 30-day trailing volume weighted average price at
that time.
- In September 2019, Xenon entered
into an agreement with Flexion Therapeutics, Inc. (Nasdaq:FLXN)
that provides Flexion with the global rights to develop and
commercialize XEN402, a Nav1.7 inhibitor. Flexion’s pre-clinical
program, known as FX301, consists of XEN402 formulated for extended
release from a thermosensitive hydrogel. The initial development of
FX301 is intended to support administration as a peripheral nerve
block for control of post-operative pain. Flexion has indicated
that it anticipates initiating FX301 clinical trials in 2021.
Corporate Updates
- Effective immediately, Dr. Clarissa
Desjardins has been appointed to Xenon’s Board of Directors and
will also serve on the Compensation Committee. An award-winning
entrepreneur with over 25 years of biotechnology experience, Dr.
Desjardins has a doctorate in neurology and neurosurgery from
McGill University’s Faculty of Medicine. In 2011, Dr. Desjardins
founded Clementia Pharmaceuticals, a publicly traded biotechnology
company focused on rare bone disorders that was acquired by Ipsen
S.A. in 2019 for up to $1.3 billion. Dr. Richard Scheller will
resign from Xenon’s Board effective January 14, 2020 after serving
as an independent director since 2015.
Dr. Pimstone stated, “I am pleased to welcome
Clarissa Desjardins to our Board of Directors. With her extensive
biotechnology, entrepreneurial, and neuroscience background,
Clarissa is a superb addition to Xenon’s Board. I expect her
contributions will be invaluable as we continue to advance our
clinical programs and strive to develop new therapeutics for
patients in need. I also wish to thank Richard for his esteemed
counsel and service on our Board of Directors. The Xenon team
wishes him well in all of his future endeavors.”
About Xenon Pharmaceuticals
Inc.
We are a clinical stage biopharmaceutical
company committed to developing innovative therapeutics to improve
the lives of patients with neurological disorders, including rare
central nervous system (CNS) conditions. 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 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 and supporting
assumptions are not based on historical fact, and include
statements regarding the timing of and results from clinical trials
and pre-clinical development activities, including those related to
XEN496, XEN1101, XEN007, and other proprietary products, and those
related to NBI-921352, FX-301, and other partnered product
candidates; the potential efficacy, safety profile, future
development plans, addressable market, regulatory success and
commercial potential of XEN496, XEN1101, XEN007 and other
proprietary and partnered product candidates; the anticipated
timing of IND, or IND equivalent, submissions and the initiation of
future clinical trials for XEN496, XEN1101, XEN007, and other
proprietary products, and those related to NBI-921352, FX-301, and
other partnered candidates; the efficacy of our clinical trial
designs; our ability to successfully develop and achieve milestones
in the XEN496, XEN1101, XEN007 and other proprietary development
programs; the timing and results of our interactions with
regulators; the potential to advance certain of our product
candidates directly into Phase 2 or later stage clinical trials;
anticipated enrollment in our clinical trials and the timing
thereof; the progress and potential of our other ongoing
development programs; the potential receipt of milestone payments
and royalties from our collaborators and the timing of potential
publication or presentation of future clinical data. 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 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 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 not permit certain of our product
candidates to advance directly into a Phase 2 or later clinical
trials, 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; 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 Xenon Pharmaceuticals Inc. Phone: 604.484.3353 Email:
investors@xenon-pharma.com
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