-- Additional Proof-of-Concept Phase 2 Studies
Planned to Initiate in 2017 --
-- Exploratory Phase 2 MS Study Results by Year
End 2017 --
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Flex Pharma, Inc. (NASDAQ: FLKS) today announced that it is
prioritizing its clinical programs in the severe neurological
diseases of amytrophic lateral sclerosis (ALS), multiple sclerosis
(MS) and peripheral neuropathies such as Charcot-Marie Tooth (CMT).
The Company intends to initiate one or two additional
proof-of-concept Phase 2 studies in these indications in the US
this year with FLX-787, its transient receptor potential (TRP) ion
channel activator, formulated as an oral disintegrating tablet. In
late 2016, the Company began enrolling MS and ALS patients in two
separate exploratory Phase 2 studies in Australia. These
randomized, controlled, blinded, cross-over studies are designed to
evaluate the safety and efficacy of FLX-787 in patients who suffer
from cramps and spasticity as a consequence of their disease. The
Company expects to report results from the exploratory MS study by
year end 2017.
“By prioritizing our clinical programs to severe neurological
diseases ahead of nocturnal leg cramps, we can focus on those
patients with the greatest unmet need and accelerate our research
efforts for cramps and spasticity,” said Flex Pharma Chief Medical
Officer Thomas Wessel, M.D., Ph.D. “In 2017, we expect to have
multiple Phase 2 studies ongoing with our single agent candidate,
FLX-787, with results from our MS study towards the end of the
year.”
“We believe that topical Chemical Neuro Stimulation, the process
whereby small molecules activate TRP ion channels on sensory nerves
in the oral mucosa, triggers a reflex response to inhibit the
hyperexcitable motor neurons in the spinal cord and reduce muscle
cramps,” noted Dr. Rod MacKinnon, Nobel laureate and Flex Pharma
Scientific Co-Founder, Board Member, and Scientific Advisory Board
Co-Chair. “Our approach has a broad range of applications that we
believe will ultimately benefit the millions of people that suffer
from frequent painful muscle cramps.”
"Flex is well funded through early 2019, and we are committed to
executing upon our mission of helping people who suffer from
painful and debilitating cramps," stated Christoph Westphal, M.D.,
Ph.D., Chair and CEO of Flex Pharma.
About ALS, MS and CMT
Amytrophic lateral sclerosis (ALS) is a neurological disease
that causes muscle weakness and impacts physical function. ALS
often begins with muscle twitching and weakness in an arm or leg,
or sometimes with slurring of speech. Eventually, ALS can affect
the ability to control the muscles needed to move, speak, eat and
breathe. ALS patients commonly experience fasciculations, which are
persistent muscle twitches that can interfere with sleep, and over
half of all patients with ALS also experience painful muscle cramps
that can significantly decrease their quality of life. Based on a
report published by the Centers for Disease Control, we estimate
that over 12,000 people in the US suffer from ALS.
Multiple sclerosis (MS) is an autoimmune disease in which
inflammatory processes cause worsening demyelination and cell
degeneration over years, resulting in a variety of neurological
deficits such as loss of muscle control, sensation and vision.
Spasticity is caused by damage to motor systems in the brain and
spinal cord. These lesions cause hyperactive muscle stretch
reflexes, which result in increased muscle tone and associated
symptoms such as myoclonus which are subsumed under the descriptive
term spasticity. The need to treat spasticity increases as the
disease progresses and go hand in hand with worsening weakness
leading to complications such as contractures, bed sores and severe
pain. According to the National Institute of Neurological Disorders
and Stroke, between 250,000 and 350,000 people in the US suffer
from MS and approximately 84% of patients with MS experience
spasticity.
Charcot-Marie-Tooth (CMT) is the most common form of inherited
neuromuscular disease, affecting an estimated 150,000 people in the
US. It occurs in populations worldwide with a prevalence of about 1
in 2,500 individuals. The primary clinical features of this
disorder are slowly progressive distal weakness, muscle atrophy
affecting the feet and legs, and sensory loss. The presence of
muscle cramps in hands, fingers, and other muscles commonly
affected in CMT patients is consistent with the hypothesis that
motor nerve dysfunction (hyperexcitability) underlies muscles
cramps. A large majority of CMT patients experience muscle cramps
frequently, in many muscles, which interferes with sleep, exercise
and daily activities. Muscle cramps have been reported as a
significant detriment to quality of life.
About Flex Pharma
Flex Pharma, Inc. is a biotechnology company that is developing
innovative and proprietary treatments for cramps and spasms
associated with the severe neurological diseases of ALS, MS and
peripheral neuropathies such as Charcot-Marie-Tooth (CMT). Flex
Pharma was founded by National Academy of Science members Rod
MacKinnon, M.D. (2003 Nobel Laureate), and Bruce Bean, Ph.D.,
recognized leaders in the fields of ion channels and neurobiology,
along with Chair and CEO Christoph Westphal, M.D., Ph.D.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements for
purposes of the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. We may, in some cases, use terms
such as “predicts,” “believes,” “potential,” “proposed,”
“continue,” “estimates,” “anticipates,” “expects,” “plans,”
“intends,” “may,” “could,” “might,” “will,” “should” or other words
that convey uncertainty of future events or outcomes to identify
these forward-looking statements. Forward-looking statements
include statements regarding our intentions, beliefs, projections,
outlook, analyses or current expectations concerning, among other
things: our expectations regarding current and future studies of
our product candidates, including the success and timing of these
studies and our beliefs regarding the potential benefits of our
current product candidates. These forward-looking statements are
based on management’s expectations and assumptions as of the date
of this press release and are subject to numerous risks and
uncertainties, which could cause actual results to differ
materially from those expressed or implied by such statements.
These risks and uncertainties include, without limitation: the
status, timing, costs, results and interpretations inherent in
conducting clinical studies, including receiving regulatory
approval of our investigational new drug application required to
conduct these studies; the fact that we rely on third parties to
manufacture and conduct the clinical studies of our product
candidates, which could delay or limit future development or
regulatory approval; results from ongoing and planned preclinical
development; expectations of our ability to make regulatory filings
and obtain and maintain regulatory approvals; results of early
clinical studies as indicative of results of future trials; the
inherent uncertainties associated with intellectual property; and
other factors discussed in greater detail under the heading “Risk
Factors” in our Annual Report on Form 10-K for the year ended
December 31, 2015 and subsequent filings with the Securities and
Exchange Commission (SEC). You are encouraged to read Flex Pharma’s
filings with the SEC, available at www.sec.gov, for a discussion of
these and other risks and uncertainties. Any forward-looking
statements that we make in this press release speak only as of the
date of this press release. We assume no obligation to update our
forward-looking statements whether as a result of new information,
future events or otherwise, after the date of this press
release.
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version on businesswire.com: http://www.businesswire.com/news/home/20170124005550/en/
Flex Pharma, Inc.Elizabeth Woo, 617-874-1829SVP, Investor
Relations & Corporate Communicationsirdept@flex-pharma.com
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