Flex Pharma Initiates ALS Phase 2 Trial with FLX-787 in US
August 01 2017 - 7:30AM
Business Wire
-- Development of FLX-787 for ALS under Fast
Track Designation --
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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 COMMEND trial.
The COMMEND trial will evaluate FLX-787, the Company’s co-activator
of TRPA1 and TRPV1, in patients with motor neuron disease (MND),
focused on ALS, who suffer from painful, debilitating cramps. The
FDA has granted FLX-787 Fast Track designation for the treatment of
severe muscle cramps associated with ALS. The Company expects to
report topline results from this study in the middle of 2018. The
Company also intends to initiate a Phase 2 clinical trial in CMT
this quarter.
“Muscle cramps can have a severe impact on functional
performance and quality of life for patients with motor neuron
diseases like ALS,” indicated lead investigator Dr. Bj�rn Oskarsson
of the Mayo Clinic in Jacksonville, Florida. “Neurologists are
often confronted with a situation where the patient experiences
symptoms, and current treatments are either ineffective or have
potentially limiting side effects. Flex Pharma’s FLX-787 may
provide a better approach to this challenging problem.”
“The Fast Track designation for FLX-787 is a validation by FDA
that cramps are a severe, unmet medical need in ALS,” commented Dr.
William McVicar, Flex Pharma President and CEO. “While physicians
treating ALS patients have come to understand how great an impact
severe cramping – and the pain that attends it – can have on the
lives of ALS patients, the lack of safe and effective and
treatments has provided little impetus to focus on the problem. We
are working hard to change this with FLX-787.”
About the COMMEND Clinical Trial
The COMMEND trial is a Phase 2 clinical trial designed to
evaluate FLX-787 in patients with motor neuron disease (MND),
focused on ALS, 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/20170801005336/en/
Flex Pharma, Inc.Elizabeth Woo, 617-874-1829SVP, Investor
Relations & Corporate Communicationsirdept@flex-pharma.com
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