Enrollment Completed in Flex Pharma’s Phase 2 Exploratory Spasticity Study in MS
-- Company to Report Results Late Q1 2018 --
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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.
Flex Pharma, Inc.
Elizabeth Woo, 617-874-1829
SVP, Investor Relations & Corporate Communications
irdept@flex-pharma.com
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