Flex Pharma Completes Enrollment of Human Proof-of Concept Efficacy Study in Nocturnal Leg Cramps
July 26 2016 - 8:00AM
Business Wire
-- Topline Results Expected Ahead of Plan, by
Year End, for Single Molecule TRP Ion Channel Activator in
Randomized, Blinded, Controlled, Cross-over Study --
Click to Tweet this News
Flex Pharma, Inc. (NASDAQ: FLKS) today announced that it has
completed enrollment of its human proof-of-concept efficacy study
in nocturnal leg cramps (NLC) with its chemically synthesized,
single molecule, transient receptor potential (TRP) ion channel
activator, formulated as an orally disintegrating tablet. Subject
enrollment for this study initiated in late May and completed ahead
of plan. This randomized, blinded, controlled, cross-over study is
designed to evaluate the safety and efficacy of its single agent in
over 50 subjects who suffer from frequent nocturnal leg cramps.
Topline results are expected by year end.
Nocturnal leg cramps can cause severe pain, interrupted sleep,
reduced quality of life and can interfere with activities of daily
living. The Company estimates that NLC affects over four million
Americans nightly. There is no approved therapeutic in the United
States to treat this condition.
“The rapid enrollment into this study underscores the
substantial unmet need for a therapeutic agent for people who
suffer from frequent leg cramps at night,” 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®. “Given the underlying mechanism of
alpha motor neuron hyperexcitablity in cramps and spasms, we have
also initiated a Phase 2 study with our single agent for patients
with MS, and we expect to begin our Phase 2 study in ALS patients
later this year.” These studies in MS and ALS will be conducted
outside the U.S.
“Flex Pharma’s agent is the leading clinical candidate for NLC
and I am hopeful that their efforts will ultimately help the
millions of people who suffer from this painful condition and
currently have no safe and effective therapeutic options,” noted
John Winkelman, M.D., Ph.D., Chief of the Sleep Disorders Clinical
Research Program at Massachusetts General Hospital and Flex Pharma
Scientific Advisory Board member, who was involved in the clinical
development of both Requip® and Mirapex®, approved agents for
restless legs syndrome (RLS).
The current study builds upon a completed, successful,
randomized, controlled, blinded cross-over study (n=50), in which
the Company’s extract formulation demonstrated statistically
significant positive human efficacy on the key endpoints. Results
from that study were accepted and presented as a late-breaker at
the American Academy of Neurology Annual Meeting in April 2016.
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 MS and ALS, 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.
Visit www.TeamHOTSHOT.com for updates and to learn more about
HOTSHOT™, the Company’s consumer product which is
scientifically proven to prevent and treat muscle cramps.
HOTSHOT is a consumer product that is marketed to endurance
athletes for exercise-associated muscle cramps. HOTSHOT complements
the Company’s drug development business and is not intended to
diagnose, treat, cure or prevent any disease.
Follow Flex Pharma (@flexpharma) and HOTSHOTTM( @Team_HOTSHOT)
on Twitter
Cautionary Note on Forward-Looking StatementsThis 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 studies of our current product candidates, including the
success and timing of these studies; our beliefs regarding the
potential benefits of our current product candidates; and
expectations regarding the number of individuals that may suffer
from nocturnal leg cramps. 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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20160726005462/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 Jun 2024 to Jul 2024
FLEX PHARMA, INC. (NASDAQ:FLKS)
Historical Stock Chart
From Jul 2023 to Jul 2024