-- Statistically Significant Reduction in Cramp-Associated Pain Intensity and Stiffness; Strong and Consistent Trends on Multiple Endpoints Including Anti-Cramp Activity --
-- First Clinical Evidence of Effect for FLX-787 in Neurological Disease --
-- US Phase 2b Trial of FLX-787 for ALS Cramping Ongoing under Fast Track Designation --
Conference Call Scheduled Today at
“We are encouraged by the consistently positive impact of FLX-787 across
multiple efficacy endpoints related to cramping and the associated pain,
despite the small number of patients completing the study,” said Dr.
In eight patients who completed the trial per protocol, FLX-787 demonstrated a statistically significant (p<0.05) percentage reduction from baseline in both cramp-associated pain intensity and stiffness, relative to placebo control, based on daily patient assessments by Numerical Rating Scale (NRS). Strong and consistent trends were demonstrated on multiple endpoints, including: percentage reduction in the number of cramps from baseline (p=0.08), increase in cramp free days from baseline (p=0.09), and improvements on both the Patient (PGIC; p=0.06) and Clinician (CGIC; p=0.06) Global Impression of Change. FLX-787 was generally well tolerated.
In the patients completing both cross-over periods per protocol:
- FLX-787 showed a median 31% reduction in cramps from baseline versus 0.1% reduction for patients while on placebo control;
- Patients had a median of 4.4 cramp free days versus 0 for placebo control;
- Patients evaluated themselves as improved with FLX-787 treatment 50% of the time versus 12.5% with placebo control (PGIC); and
- Clinicians blinded to treatments evaluated 50% of patients as improved with FLX-787 versus 0% for placebo control (CGIC).
The Company also analyzed the Period 1 and Period 2 results of all patients randomized in the trial and believes the cross-over results are not driven by a cross-over bias or unblinding effect.
“Nearly all ALS patients report cramps and the majority seek treatment
to relieve their suffering from painful cramping and yet there are no
approved therapies in the US. This data set provides the first clinical
evidence that FLX-787 has an effect in patients with underlying
neurological disease and demonstrates the utility of chemical
neurostimulation in treating symptoms arising from motor neuron
Data from this study outlined above will be presented at future medical meetings.
Phase 2 Trial Design
This randomized, blinded, placebo-controlled Phase 2 clinical trial, had
originally planned to enroll up to 60 subjects with ALS or primary
lateral sclerosis (PLS) patients with frequent muscle cramps in
About the COMMEND Clinical Trial
The COMMEND trial is an ongoing Phase 2b 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 includes a 28-day run-in period to establish a baseline in cramp frequency. Patients are then 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, including the PGIC, CGIC, cramp-related pain and spasticity.
Details of this trial can be found at clinicaltrials.gov.
Conference Call & Webcast Information
Dial-in: (855) 780-7202 (US and
Replay: (855) 859-2056 (US and
Conference ID: 3497649
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
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
Flex Pharma, Inc.
Elizabeth Woo, 617-874-1829
SVP, Investor Relations & Corporate Communications