Flex Pharma Reports Positive Topline Data from Exploratory Phase 2 Trial of FLX-787 in Multiple Sclerosis
March 26 2018 - 7:00AM
Business Wire
- FLX-787 reduced cramp/spasm frequency
(p=0.0017) and increased cramp-free days (p=0.0457) in MS patients
in a pre-specified analysis of the parallel treatment phase
- Treating physicians reported
improvement in spasticity in patients receiving FLX-787 as measured
by the Clinical Global Impression of Change (CGI-C) in
pre-specified analyses (p=0.01 parallel period, p=0.0427 both
cross-over periods)
- FLX-787 was generally well tolerated
with no treatment-related serious adverse events reported
- Conference Call Scheduled Today at 8:45
a.m. EDT
Flex Pharma, Inc. (NASDAQ:FLKS), a clinical-stage biotechnology
company that is developing innovative and proprietary treatments
for cramps, spasms and spasticity associated with severe
neurological diseases such as multiple sclerosis (MS),
Charcot-Marie-Tooth (CMT) and amyotrophic lateral sclerosis (ALS)
under FDA Fast Track designation today announced positive topline
data for FLX-787 from its exploratory Phase 2 trial in MS patients
with frequent muscle cramps/spasms and spasticity.
“MS patients frequently complain of cramps, spasms, and
spasticity which can dramatically affect their quality of life,”
said Anneke van der Walt, MBChB, FRACP, PhD. Associate Professor of
Neurology, Royal Melbourne Hospital, University of Melbourne,
Australia, and lead investigator of the study. “These new data
suggest that FLX-787 may have the potential to address this
important unmet medical need.”
FLX-787 at a dose of 19 mg, taken orally twice daily, in a
liquid formulation was evaluated in an exploratory Phase 2
randomized, double-blinded, placebo-controlled, cross-over trial in
57 MS patients.
In the evaluation of FLX-787 for its impact on MS patients’
cramps/spasms and spasticity, pre-specified analyses of the
parallel portion of the study showed:
- A statistically significant 27.3%
reduction in the frequency of cramps/spasms compared with control
(p=0.001)
- A 1.4 day increase in cramp/spasm-free
days per 14 day period compared with control (p=0.0457)
- Clinician-rated improvement in
spasticity with FLX-787 treatment was significantly better than
control (p=0.01)
- Treating physicians reported that 7 of
28 (25%) patients on FLX-787 had “Much Improved” or “Very Much
Improved” spasticity versus 0 of 26 (0%) on control based upon the
Clinical Global Impression of Change in Spasticity
In the evaluation of FLX-787 from data that included both
cross-over periods in the intent-to-treat (ITT) population:
- The pre-specified analysis of Clinical
Global Impression of Change (CGI-C) in the patient’s spasticity
showed statistically significant greater improvement with FLX-787
relative to control (p=0.0427)
- No statistically significant
improvement was seen in cramp/spasm frequency, NRS or clinical
spasticity scales
FLX-787 was generally well tolerated and resulted in no
drug-related serious adverse events. GI-related adverse events
(diarrhea and nausea) were infrequently reported with FLX-787.
“We see in these data the clear potential of FLX-787 to improve
cramps and spasticity in patients with MS,” stated William McVicar,
PhD., Flex Pharma President and CEO. “Based upon these strong data
and the learnings from this study, we look forward to the
development and execution of a refined phase 2b study as part of
our full FLX-787 clinical development program.”
“Late last year, FLX-787 demonstrated a similar efficacy profile
in a small exploratory study of ALS patients. Our MS trial results
provide a second set of clinical evidence that FLX-787 may provide
beneficial activity in patients with underlying neurological
disease and demonstrates the potential of chemical neurostimulation
in treating symptoms arising from motor neuron and reflex
hyperexcitability,” said Flex Pharma Chief Medical Officer Thomas
Wessel, M.D., Ph.D.
Data from this study outlined above will be presented at future
medical meetings.
Conference Call & Webcast Information
The Flex Pharma management team will host a conference call and
live webcast with slides with the investment community today,
Monday, March 26, at 8:45 am EDT to discuss the information in this
press release.
Date: Monday, March 26, 2018Time: 8:45 am EDTDial-in:
855-780-7202Replay: 855-859-2056Conference ID: 1476389
The live webcast and accompanying slides can be accessed under
the investor relations section of Flex Pharma’s website at
www.flex-pharma.com. A replay of the conference call will be
archived under the investor relations section of the Flex Pharma
website for three months after the call.
About FLX-787
FLX-787 is an orally disintegrating tablet that is designed to
treat cramps, spasms and spasticity associated with severe
neurological conditions including ALS, MS and peripheral
neuropathies such as Charcot-Marie-Tooth (CMT). FLX-787 is a novel
dual transient receptor potential A1/V1 (TRPA1/V1) ion channel
activator designed to dampen the underlying hyperexcitability of
spinal circuits responsible for cramps, spasms and spasticity. It
has shown significant inhibition of electrically-induced muscle
cramps (EIC), nocturnal leg cramps (NLC) in healthy adults and
cramps in ALS patients. FLX-787 is being developed under Fast Track
designation for the treatment of severe muscle cramps associated
with ALS.
About Flex Pharma
Flex Pharma, Inc. is a clinical-stage biotechnology company
developing innovative and proprietary treatments in Phase 2
randomized, controlled trials for cramps, spasms and spasticity
associated with the severe neurological conditions 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.
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. These forward-looking statements
include statements regarding our intentions, beliefs, projections,
outlook, analyses or current expectations concerning, among other
things: the progress, timing, scope and results of ongoing and
anticipated clinical studies. 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;
results from our ongoing and planned preclinical development;
expectations of our ability to make regulatory filings and obtain
and maintain regulatory approvals; our ability to successfully
commercialize our consumer product; results of early clinical
studies as indicative of the results of future trials; availability
of funding sufficient for our foreseeable and unforeseeable
operating expenses and capital expenditure requirements; other
matters that could affect the availability or commercial potential
of our consumer or drug product candidates; and the inherent
uncertainties associated with intellectual property. Other factors
that may cause actual results to differ from those expressed or
implied in the forward-looking statements in this press release are
discussed in our filings with the U.S. Securities and Exchange
Commission (SEC), including the "Risk Factors" contained therein.
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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InvestorsFlex Pharma, Inc.Elizabeth Woo, 617-874-1829SVP,
Investor Relations & Corporate
Communicationsirdept@flex-pharma.comorMediaMedical
DynamicsSophia Ononye, 212-537-9495sononye@rxmedyn.com
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