Flex Presents Human Efficacy Data On FLX-787 At American Academy of Neurology Annual Meeting

BOSTON--(BUSINESS WIRE)--Click to Tweet this News

“further clarify the functional role of human TRPA1, and underscores the importance of this ion channel as a potential therapeutic target.”

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) 69^th 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 27^th, 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 27^th, 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.

Cautionary Note on 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. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: our expectations regarding current and future studies of our product candidates, including the success and timing of these studies and our beliefs regarding the potential benefits of our current product candidates. 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 interpretations inherent in conducting clinical studies, including receiving regulatory approval of our investigational new drug application required to conduct these studies; the fact that we rely on third parties to manufacture and conduct the clinical studies of our product candidates, which could delay or limit future development or regulatory approval; results from ongoing and planned preclinical development; expectations of our ability to make regulatory filings and obtain and maintain regulatory approvals; results of early clinical studies as indicative of results of future trials; 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 December 31, 2016 and subsequent filings with the Securities and Exchange Commission (SEC). You are encouraged to read Flex Pharma’s 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.