Flex Pharma, Inc. (NASDAQ: FLKS), focused on developing treatments for cramps and spasms associated with the severe neurological diseases of ALS, MS and peripheral neuropathies such as Charcot-Marie-Tooth (CMT), today announced that human efficacy data from its study in nocturnal leg cramps (NLC) will be presented at the upcoming American Academy of Neurology (AAN) 69th Annual Meeting in Boston, MA. When a neurologist evaluated, in a blinded manner, subjects likely to have NLC based upon a questionnaire administered after the study was completed, the data from first treatment exposure of these 26 subjects showed a statistically significant effect in the reduction in cramp frequency when compared to placebo (p=0.03).
The abstract titled, “Chemical Neuro Stimulation by FLX-787, a co-activator of TRPA1/TRPV1, for the Potential Treatment of Cramps, Spasms and Spasticity,” will be presented April 27th, 2017 from 5:30-7:00pm in a poster presentation.
“We have gained important insights from this exploratory study, in addition to several randomized, controlled human efficacy studies previously reported at scientific meetings, and have a better understanding how NLC patients benefit from TRP channel activation,” said Flex Pharma Chief Medical Officer Thomas Wessel, M.D., Ph.D. “Our focus now is to explore the impact of FLX-787 on muscle cramps and spasms in neurological conditions with our Phase 2 studies currently underway in MS and ALS in Australia, as well as Phase 2 studies planned to initiate in the US this summer in ALS and CMT.”
“We are also intrigued by recent data from independent researchers at NYU and Mount Sinai that implicate TRPA1 ion channelopathy in cramp fasciculation syndrome,” said Flex Pharma R&D President Bill McVicar, Ph.D. “Our data, in a human electrically-induced cramp model, indicates that co-activation of TRPA1 and TRPV1 is required to decrease hyperexcitability, and this has led to the selection of our TRPA1/TRPV1 co-activator, FLX-787, for clinical evaluation. Their work appears to be consistent, and showed that a mutation suppressing signaling from just one of these two ion channels – TRPA1 – perhaps attenuating co-signaling, is associated with hyperexcitability underlying fasciculations, cramps, spasms and spasticity.”
The Biller et al. abstract titled, “Identification of a novel TRPA1 mutation associated with carbamazepine-responsive cramp-fasciculation syndrome” will be presented April 27th, 2017 at 4:54pm. The authors from NYU and Mount Sinai conclude that their findings “further clarify the functional role of human TRPA1, and underscores the importance of this ion channel as a potential therapeutic target.” Cramp fasciculation syndrome is a muscle hyperexcitability syndrome that may present with muscle cramps, stiffness and fasciculations.
About Flex Pharma
Flex Pharma, Inc. is a biotechnology company that is developing innovative and proprietary treatments for cramps and spasms associated with the severe neurological diseases of ALS, MS and peripheral neuropathies such as 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.
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