Flex Pharma Reports Positive Topline Data from Exploratory Phase 2 Trial of FLX-787 in Multiple Sclerosis

On Mar 26, 2018

Flex Pharma 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.