Flex Pharma Initiates Phase 2 Efficacy Study in Amyotrophic Lateral Sclerosis
September 13 2016 - 7:30AM
Business Wire
-- Tablet Formulation of FLX-787, A Single
Molecule, Synthesized, TRP Ion Channel Activator, in Randomized,
Controlled, Cross-over Study --
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Flex Pharma, Inc. (NASDAQ: FLKS) today announced that it has
initiated a Phase 2 efficacy study in amyotrophic lateral sclerosis
(ALS) patients in Australia with FLX-787, its chemically
synthesized, single molecule, transient receptor potential (TRP)
ion channel activator, formulated as an oral tablet. The
randomized, controlled, blinded, cross-over study is designed to
evaluate the safety and efficacy of FLX-787 in patients who suffer
from cramps and/or spasticity as a consequence of ALS.
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 United States suffer from ALS.
“We have initiated three human efficacy studies this year – in
nocturnal leg cramps, multiple sclerosis and now ALS – with our
single agent candidate, FLX-787,” said Flex Pharma Chief Medical
Officer Thomas Wessel, M.D., Ph.D., who served as the medical lead
for three products approved in United States: Razadyne®, Lunesta®
and Ampyra®. “We are hopeful that our efforts will ultimately help
the many patients with severe neuromuscular diseases who suffer
from these painful conditions.”
“Topical Chemical Neuro Stimulation is a process whereby small
molecules activate TRP ion channels on sensory nerves in the oral
mucosa, which we hypothesize signal through neural circuits to
inhibit the hyperexcitable motor neurons in the spinal cord that
can cause muscle cramps,” noted Dr. Rod MacKinnon, Nobel laureate
and Flex Pharma Scientific Co-Founder, Board Member, and Scientific
Advisory Board Co-Chair. “We hypothesize that this approach may be
generally applicable as a treatment for cramps and spasms in a
spectrum of neuromuscular conditions.”
About Flex Pharma
Flex Pharma, Inc. is a biotechnology company that is developing
innovative and proprietary treatments for nocturnal leg cramps,
cramps and spasms associated with severe neuromuscular conditions
such as ALS and MS, and exercise-associated muscle cramps. 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 future studies of our current
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 of our clinical
studies; the uncertainties inherent in conducting clinical studies,
including receiving regulatory approval 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/20160913005470/en/
Flex Pharma, Inc.Elizabeth Woo, 617-874-1829SVP, Investor
Relations & Corporate Communicationsirdept@flex-pharma.com
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