Flex Pharma’s Phase 2 Trial with FLX-787 in Charcot-Marie-Tooth Endorsed by the Inherited Neuropathies Consortium
June 02 2017 - 8:00AM
Business Wire
-- US Phase 2 Trial of FLX-787 in CMT Patients
to Start This Summer --
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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 including amyotrophic lateral sclerosis (ALS), multiple
sclerosis (MS) and Charcot-Marie-Tooth (CMT), today announced that
the Inherited Neuropathies Consortium (INC) voted to endorse the
Company’s U.S. Phase 2 Trial of FLX-787 in CMT patients who suffer
from cramps. The INC is an integrated group of academic medical
centers, patient support organizations, and clinical research
resources dedicated to conducting clinical research in CMT and to
improving the care of patients
(www.rarediseasesnetwork.org/cms/inc). There are currently no drug
products approved in the U.S. for this condition. The Company
expects to begin enrolling U.S. patients this summer in this
randomized, controlled, double-blinded, parallel design study,
referred to as the COMMIT trial. FLX-787 is a
small molecule co-activator of the TRPA1 and TRPV1 ion channels,
and has been shown to suppress muscle cramps in a human model of
electrically induced cramps, and to reduce cramping frequency and
the associated pain in spontaneously occurring cramps in a
population with nocturnal leg cramps.
“The Inherited Neuropathies Consortium welcomes this clinical
research effort to develop a novel treatment for muscle cramps in
patients with CMT neuropathy. Cramping is a very common and often
disabling symptom of this disease,” remarked Dr. Michael Shy, an
internationally known neuropathy researcher at the University of
Iowa, which is the INC’s operational center. “We have reviewed the
protocol and our organization will reach out to patients with
muscle cramps to encourage their participation in this interesting
study.”
“Muscle cramping can have a significant impact on our patients
with CMT neuropathy, and we have compelling data in pediatric and
adult populations showing the deterioration in quality of life that
many of our patients experience due to frequent cramping,” stated
CMT clinical trial lead investigator, Dr. Nicholas Johnson,
Assistant Professor of Neurology, Pediatrics and Pathology at the
University of Utah. “FLX-787 could have meaningful clinical
advantages because of its safety profile and the lack of systemic
exposure.”
“We are thrilled to soon be starting our second US Phase 2 trial
with FLX-787. This study in CMT neuropathy is our second orphan
indication in neurology,” said Flex Pharma Chief Medical Officer
Thomas Wessel, M.D., Ph.D. “With two Phase 2 clinical trials in ALS
and CMT expected to initiate this summer in the US, together with
our ongoing exploratory Phase 2 studies in Australia, FLX-787 will
be amongst the most advanced, novel compounds in the clinic for ALS
and CMT.”
“We are excited that many INC study sites in the US will
participate in our Phase 2 trial with FLX-787 which should speed
recruitment,” commented Bill McVicar, Flex Pharma President of
Research & Development. “The R&D team is focused on the
execution of these new Phase 2 IND studies, as well as completion
of the ongoing exploratory Phase 2 work in Australia, which are
expected to result in several important data readouts in 2018.”
COMMIT Trial Design
The COMMIT trial is a Phase 2 clinical trial designed to
evaluate FLX-787 in patients with CMT who suffer from cramps. This
randomized, controlled, double-blinded, parallel design trial in
the U.S. 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
including ALS, MS and 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.
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 our anticipated clinical trials and
expectations regarding the pace of enrollment in our study of
patients with CMT. 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/20170602005198/en/
Flex Pharma, Inc.Elizabeth Woo, 617-874-1829SVP, Investor
Relations & Corporate Communicationsirdept@flex-pharma.com
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