Enrollment Completed in Flex Pharma’s Phase 2 Exploratory Spasticity Study in MS
November 28 2017 - 8:00AM
Business Wire
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Flex Pharma, Inc. (NASDAQ: FLKS), a clinical-stage biotechnology
company that is developing innovative and proprietary treatments in
Phase 2 randomized, controlled trials for cramps and spasticity
associated with severe neurological diseases such as multiple
sclerosis (MS), Charcot-Marie-Tooth (CMT) and amyotrophic lateral
sclerosis (ALS) under FDA Fast Track designation, today announced
that it has completed enrollment in its Phase 2 exploratory
spasticity study in multiple sclerosis (MS) with approximately 50
patients in Australia. The randomized, placebo-controlled, blinded,
cross-over study is designed to evaluate the safety and efficacy of
FLX-787, the Company’s single molecule, chemically synthesized,
dual A1/V1 transient receptor potential (TRPA1/V1) ion channel
activator, in patients who suffer from spasticity, cramps and
spasms as a consequence of MS.
MS is an autoimmune disease in which inflammatory lesions cause
demyelination, and eventually degeneration, of nerve cells over
years. This loss of nerve function can result in a variety of
neurological deficits such as loss of sensation, vision, and muscle
control and coordination, including spasticity. Spasticity is
caused by damage to motor neurons in the brain and spinal cord.
These lesions unmask hyperactive muscle stretch reflexes that
result in persistent electrical activity in the muscle. This
aberrant electrical activity – like that seen in muscle cramping –
can be measured by electromyography (EMG). This stretch-triggered
electrical activity in the muscle produces muscle stiffness during
motion, or spasticity. We believe that this reflex
hyperexcitability, like the alpha motor neuron hyperexcitability
that produces cramping, can benefit from greater inhibition in the
spinal circuitry generated by chemical neurostimulation with TRP
activators like FLX-787. According to the National Institute of
Neurological Disorders and Stroke, between 250,000 and 350,000
people in the United States suffer from MS and approximately 84% of
patients with MS experience spasticity. This spasticity can be
moderate to severe in almost half of the population, and the need
for treatment to alleviate it increases as the disease
progresses.
“Neurologists have very limited therapeutic options for patients
suffering from MS spasticity and the current options are often
suboptimal due to their associated side effects,” stated Flex
Pharma Chief Medical Officer Thomas Wessel, M.D., Ph.D. “Our
approach offers a potential important advantage as the drug
candidate may reduce cramps or spasticity without the sedating side
effects of many current therapies.”
“Given the recent ALS data supporting the efficacy signal of
FLX-787 across multiple endpoints related to cramping and the
associated pain, we are more encouraged that FLX-787 may
demonstrate a similar effect in this larger exploratory MS study
when we have the results at the end of the first quarter of next
year,” said Dr. William McVicar, Flex Pharma President and CEO.
“With data readouts in MS, ALS, and CMT expected over the next
year, we are excited to advance the development of FLX-787 in
multiple neurological settings to help these patients who have very
limited treatment options to address their chronic cramping and
spasticity.”
About Flex Pharma
Flex Pharma, Inc. is a clinical-stage biotechnology company that
is developing innovative and proprietary treatments in Phase 2
randomized, controlled trials for cramps and spasticity associated
with the severe neurological diseases of ALS, MS and peripheral
neuropathies such as Charcot-Marie-Tooth (CMT). The Company’s lead
candidate, FLX-787, is being developed under Fast Track designation
for the treatment of severe muscle cramps associated with ALS. 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 Christoph Westphal, M.D., Ph.D.
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. Forward-looking statements include
statements regarding our intentions, beliefs, projections, outlook,
analyses or current expectations concerning, among other things,
the design and timing of ongoing and anticipated clinical trials,
including the timing for results of our clinical trials. 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 interpretation
of our clinical studies; the uncertainties inherent in conducting
clinical studies; our ability to enroll patients in each of
clinical studies on a timely basis; expectations of our ability to
make regulatory filings and obtain and maintain regulatory
approvals; availability of funding sufficient for our foreseeable
and unforeseeable operating expenses and capital expenditure
requirements; 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, 2016 and subsequent
filings with the Securities and Exchange Commission (SEC). You are
encouraged to read our 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/20171128005272/en/
Flex Pharma, Inc.Elizabeth Woo, 617-874-1829SVP, Investor
Relations & Corporate Communicationsirdept@flex-pharma.com
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