Accueil / Communiqués / Flex Pharma Presents Human Efficacy Data on FLX-787 at the American Academy of Neurology Annual Meeting

Flex Pharma Presents Human Efficacy Data on FLX-787 at the American Academy of Neurology Annual Meeting

Wednesday, April 19th 2017 at 12:00pm UTC

— TRPA1, Pharmacological Target of FLX-787, Genetically Linked to
Human Muscle Cramp Fasciculation Syndrome by Independent Researchers —

BOSTON–(BUSINESS WIRE)– Click to Tweet this News

Flex Pharma, Inc. (NASDAQ: FLKS), focused on developing treatments for
cramps and spasms associated with the severe neurological diseases of
ALS, MS and peripheral neuropathies such as Charcot-Marie-Tooth (CMT),
today announced that human efficacy data from its study in nocturnal leg
cramps (NLC) will be presented at the upcoming American Academy of
Neurology (AAN) 69th Annual Meeting in Boston, MA. When a
neurologist evaluated, in a blinded manner, subjects likely to have NLC
based upon a questionnaire administered after the study was completed,
the data from first treatment exposure of these 26 subjects showed a
statistically significant effect in the reduction in cramp frequency
when compared to placebo (p=0.03).

The abstract titled, “Chemical Neuro Stimulation by FLX-787, a
co-activator of TRPA1/TRPV1, for the Potential Treatment of Cramps,
Spasms and Spasticity,” will be presented April 27th, 2017
from 5:30-7:00pm in a poster presentation.

“We have gained important insights from this exploratory study, in
addition to several randomized, controlled human efficacy studies
previously reported at scientific meetings, and have a better
understanding how NLC patients benefit from TRP channel activation,”
said Flex Pharma Chief Medical Officer Thomas Wessel, M.D., Ph.D. “Our
focus now is to explore the impact of FLX-787 on muscle cramps and
spasms in neurological conditions with our Phase 2 studies currently
underway in MS and ALS in Australia, as well as Phase 2 studies planned
to initiate in the US this summer in ALS and CMT.”

“We are also intrigued by recent data from independent researchers at
NYU and Mount Sinai that implicate TRPA1 ion channelopathy in cramp
fasciculation syndrome,” said Flex Pharma R&D President Bill McVicar,
Ph.D. “Our data, in a human electrically-induced cramp model, indicates
that co-activation of TRPA1 and TRPV1 is required to decrease
hyperexcitability, and this has led to the selection of our TRPA1/TRPV1
co-activator, FLX-787, for clinical evaluation. Their work appears to be
consistent, and showed that a mutation suppressing signaling from just
one of these two ion channels – TRPA1 – perhaps attenuating
co-signaling, is associated with hyperexcitability underlying
fasciculations, cramps, spasms and spasticity.”

The Biller et al. abstract titled, “Identification of a novel TRPA1
mutation associated with carbamazepine-responsive cramp-fasciculation
syndrome” will be presented April 27th, 2017 at 4:54pm. The
authors from NYU and Mount Sinai conclude that their findings “further
clarify the functional role of human TRPA1, and underscores the
importance of this ion channel as a potential therapeutic target.” Cramp
fasciculation syndrome is a muscle hyperexcitability syndrome that may
present with muscle cramps, stiffness and fasciculations.

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, 2016 and
subsequent filings with the Securities and Exchange Commission (SEC).
You are encouraged to read Flex Pharma’s filings with the SEC, available
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

Source: Flex Pharma, Inc.

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