Flex Pharma Initiates CMT Phase 2 Trial with FLX-787 in US
October 16 2017 - 8:30AM
Business Wire
-- ALS Phase 2 Trial Currently Underway --
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Flex Pharma, Inc. (NASDAQ: FLKS), a clinical-stage biotechnology
company that is developing innovative and proprietary treatments
for cramps and spasticity associated with severe neurological
diseases such as amyotrophic lateral sclerosis (ALS) and multiple
sclerosis (MS) and peripheral neuropathies such as
Charcot-Marie-Tooth (CMT), today announced that, under its open
investigational new drug (IND) application, the Company has
initiated a Phase 2 randomized, controlled, double-blinded,
parallel design trial in the US, referred to as the COMMIT trial.
The COMMIT trial will evaluate FLX-787, the Company’s co-activator
of TRPA1 and TRPV1, in patients with Charcot-Marie-Tooth, who
suffer from painful, debilitating cramps. The Company expects to
report topline results from this study in the middle of 2018. The
Company initiated a Phase 2 clinical trial in ALS earlier this
quarter. The FDA has granted FLX-787 Fast Track designation for the
treatment of severe muscle cramps associated with ALS.
“Many of our patients with CMT neuropathy suffer from frequent
and severe muscle cramping which can limit their activities of
daily living and have a profound impact on their quality of life,”
stated CMT clinical trial lead investigator, Dr. Nicholas Johnson,
Assistant Professor of Neurology, Pediatrics and Pathology at the
University of Utah. “FLX-787 promises to have significant clinical
advantages because of its safety profile and the lack of systemic
exposure.”
“As one of the very few companies conducting interventional
studies in CMT, we are excited to be at the forefront of clinical
development for this disease, an orphan indication that is the most
common form of inherited neuromuscular disease,” commented Dr.
William McVicar, Flex Pharma President and CEO. “These new Phase 2
IND studies, as well as completion of the ongoing exploratory Phase
2 work in Australia, are expected to result in several important
data readouts in 2018.”
About the COMMIT Clinical Trial
The COMMIT trial is a Phase 2 clinical trial designed to
evaluate FLX-787 in patients with Charcot-Marie-Tooth who suffer
from cramps. This randomized, controlled, double-blinded, parallel
design trial in the US will include a run-in period to establish a
baseline in cramp frequency. Patients will then be randomized to 30
mg of FLX-787 administered three times a day, or control, for 28
days. Patients will be evaluated for changes in cramp frequency as
the primary endpoint, with a number of secondary endpoints.
About Flex Pharma
Flex Pharma, Inc. is a clinical-stage biotechnology company that
is developing innovative and proprietary treatments 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 Chair 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20171016005033/en/
Flex Pharma, Inc.Elizabeth Woo, 617-874-1829SVP, Investor
Relations & Corporate Communicationsirdept@flex-pharma.com
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