Xenon Outlines Key Milestones for 2016
January 11 2016 - 8:00AM
Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a clinical-stage
biopharmaceutical company, today outlined its anticipated key
corporate milestones for 2016.
Dr. Simon Pimstone, Xenon’s President and Chief Executive
Officer, stated: “Overall, I am very pleased with the advancements
made over the past year within both our proprietary and partnered
programs. Our pain-focused collaborations with Teva and Genentech
continue to progress well as we work to translate the therapeutic
potential of the Nav1.7 target into novel pain therapeutics. In our
proprietary programs, we met a major 2015 development milestone by
initiating and rapidly completing a Phase 1 trial for XEN801, which
is now positioned to enter a Phase 2 clinical trial in patients
with moderate to severe acne in the first quarter of 2016, with an
expected read-out of results in the second half of 2016.”
Dr. Pimstone added: “We enter 2016 in a strong position with the
necessary resources to achieve our near-term goals and to advance a
novel and diverse product portfolio. We intend to address large
therapeutic markets, such as pain, through partnered programs, and
pursue rare or orphan diseases, such as rare forms of childhood
epilepsy, by further developing proprietary assets within our own
pipeline. Additionally, we expect to continue to leverage our
Extreme Genetics technology platform to identify novel targets for
drug development.”
Anticipated Advancements of Xenon’s Proprietary
Pipeline
- XEN801, is a topical stearoyl Co-A desaturase, or SCD1
inhibitor, for the treatment of acne. Xenon’s Phase 1 clinical
trial for XEN801 was completed in December 2015 with the data
supporting the initiation of a Phase 2 clinical trial in the first
quarter of 2016. The aim of this Phase 2 trial is to evaluate the
efficacy, safety, tolerability and systemic exposure in
approximately 150 patients with moderate-to-severe acne. Xenon
anticipates receiving topline results in the second half of
2016.
- Xenon's development of a Nav1.6 sodium channel inhibitor for
the treatment of rare childhood epilepsy disorders – such as Dravet
Syndrome, an orphan disease of severe childhood epilepsy –
continues to progress, and results from early in vivo studies have
been encouraging. Xenon expects to identify a development candidate
in 2016 and file an investigational new drug (IND) application in
the first half of 2017.
- Xenon will continue to leverage its drug discovery platform to
identify validated drug targets and develop new product candidates,
and expects to provide updates as new drug discovery programs
advance in 2016.
Anticipated Milestones in Partnered
Programs
- Xenon's partner Genentech, a member of the Roche Group, is
currently conducting two Phase 1 clinical trials for GDC-0276 and
GDC-0310, which are both oral, selective Nav1.7 small-molecule
inhibitors being developed for the potential treatment of pain.
Both Phase 1 clinical trials are ongoing, and pending a full
assessment of the results, Genentech intends to initiate a Phase 2
trial in 2016.
- Xenon continues to engage in an active research collaboration
with Genentech focused on the discovery of novel pain targets in
rare human pain disorders where individuals have either an
inability to perceive pain or where individuals have
non-precipitated spontaneous severe pain. In September 2015, Xenon
announced the successful discovery and identification of a novel
pain target, which triggered a milestone payment from
Genentech.
- Xenon's partner Teva Pharmaceutical Industries Ltd. is
conducting a randomized, double-blind, placebo-controlled Phase 2b
clinical trial for TV-45070 in patients with post-herpetic
neuralgia, with results expected in the second half of 2016.
Anticipated Milestones for Commercialized
Products
- Xenon is eligible to receive a royalty on commercial sales of
Glybera®, which is licensed to uniQure Biopharma B.V.
(Nasdaq:QURE), for the treatment of the orphan disorder lipoprotein
lipase deficiency. The first patient treated with Glybera as a
commercially-available gene therapy was announced by uniQure in
November 2015 and enabled by its commercialization partner in the
EU, Chiesi Farmaceutici S.p.A.
About Xenon Pharmaceuticals Inc.
Xenon is a clinical-stage biopharmaceutical company discovering
and developing a pipeline of differentiated therapeutics for orphan
indications that it intends to commercialize on its own and for
larger market indications that the company intends to partner with
global pharmaceutical companies. Xenon has built a core enabling
discovery platform, referred to as Extreme Genetics®, for the
discovery of validated drug targets by studying rare human diseases
with extreme traits, including diseases caused by mutations in ion
channels, known as channelopathies. Xenon's Extreme Genetics®
platform has yielded the first approved gene therapy product in the
European Union and a broad development pipeline and multiple
pharmaceutical partnerships, including with Teva and Genentech. 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 progress and potential
of ongoing proprietary and partnered development programs,
including those in pain, acne, and epilepsy, the sufficiency of our
resources and capabilities to achieve our near-term goals, the
timing of IND or IND-equivalent submissions with regulatory
agencies, the timing for announcing an additional proprietary drug
discovery program, the initiation of future clinical trials, the
results of research and development efforts, the timing of and
results from ongoing clinical trials and pre-clinical development
activities and the future plans of our collaboration partners and
their interactions with regulatory agencies. 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 product candidates or
those of our collaborators; our Extreme Genetics® discovery
platform or ongoing collaborations may not yield additional product
candidates and we may not announce our next product drug discovery
program within the timelines currently contemplated; 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 pursuant to our collaboration agreements; 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. Readers are cautioned not to place undue reliance on
such forward-looking statements.
“Xenon,” the Xenon logo, and “Extreme Genetics” are registered
trademarks or trademarks of Xenon Pharmaceuticals Inc. in various
jurisdictions. Glybera is a registered trademark of uniQure
Biopharma B.V. in various jurisdictions.
Investor/Media Contact:Jodi Regts Senior
Director, Corporate Affairs Xenon Pharmaceuticals Inc. Phone:
604.484.3353 Email: investors@xenon-pharma.com
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