Flex Pharma Presents Human Efficacy Data on FLX-787 at the American Academy of Neurology Annual Meeting
April 19 2017 - 8:00AM
Business Wire
-- TRPA1, Pharmacological Target of FLX-787,
Genetically Linked to Human Muscle Cramp Fasciculation Syndrome by
Independent Researchers --
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 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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170419005281/en/
Flex Pharma, Inc.Elizabeth Woo, 617-874-1829SVP, Investor
Relations & Corporate Communicationsirdept@flex-pharma.com
FLEX PHARMA, INC. (NASDAQ:FLKS)
Historical Stock Chart
From Mar 2024 to Apr 2024
FLEX PHARMA, INC. (NASDAQ:FLKS)
Historical Stock Chart
From Apr 2023 to Apr 2024