- 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
“MS patients frequently complain of cramps, spasms, and spasticity which
can dramatically affect their quality of life,” said
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
“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
Data from this study outlined above will be presented at future medical meetings.
Conference Call & Webcast Information
Conference 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
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.
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Act of 1995. These forward-looking statements include statements
regarding our intentions, beliefs, projections, outlook, analyses or
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timing, scope and results of ongoing and anticipated clinical studies.
These forward-looking statements are based on management's expectations
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These risks and uncertainties include, without limitation: the status,
timing, costs, results and interpretation of our clinical studies; the
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our ability to successfully commercialize our consumer product; results
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actual results to differ from those expressed or implied in the
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