Flex Pharma Data Presented At American Academy of Neurology Platform Session
Company Presents Human Proof-of-Concept for Treating and Preventing Muscle Cramps
“Based upon the novel insight that topical neurostimulation via oral small molecules can act rapidly on the nervous system, we are excited that these results show that the Flex proprietary treatment is effective in reducing muscle cramping”
Flex Pharma, Inc. (NASDAQ: FLKS), a biotechnology company that is developing innovative and proprietary treatments for exercise-associated muscle cramps, nocturnal leg cramps, and spasms associated with severe neuromuscular conditions, today announced that Flex Pharma Scientific Co-Founder, Dr. Bruce Bean, presented the Company’s data under the abstract he co-authored titled, “Orally-administered TRPV1 and TRPA1 activators inhibit electrically-induced muscle cramps in normal healthy volunteers,” during an oral platform presentation at the American Academy of Neurology (AAN) 67th Annual Meeting being held in Washington, D.C.
Flex Pharma’s proprietary treatment is based on research showing that cramps are caused by excessive firing of alpha-motor neurons in the spinal cord that control muscle contraction. The treatment is designed to reduce the firing of the neurons by topically stimulating the transient receptor potential (TRP) ion channels located in the gastrointestinal tract. Physical properties of the TRP activators largely limit their action to sensory neurons in the mouth, esophagus and stomach, with minimal concentrations reaching the bloodstream and, consequently, fewer potential systemic side effects.
“Based upon the novel insight that topical neurostimulation via oral small molecules can act rapidly on the nervous system, we are excited that these results show that the Flex proprietary treatment is effective in reducing muscle cramping,” said Bruce Bean, Ph.D., Flex Pharma Scientific Co-Founder and Co-Chair of the Scientific Advisory Board. Dr. Bean is the Robert Winthrop Professor of Neurobiology at Harvard Medical School and is a member of the National Academy of Sciences. “Muscle cramping and spasticity are painful and debilitating symptoms of many neurological diseases, such as multiple sclerosis, spinal spasticity, and amyotrophic lateral sclerosis. In addition, muscle cramping is a disruptive condition for athletes and the estimated four million U.S. adults afflicted daily by nocturnal leg cramps.”
The studies evaluating this treatment consisted of three randomized, blinded, placebo-controlled crossover designs in a total of 37 healthy volunteers. The primary endpoint of each study was to evaluate the efficacy of the treatment in preventing muscle cramps. Each of the studies showed statistically significant results, demonstrating that Flex Pharma’s treatment reduced electrically induced muscle cramps within 15 minutes, and its effect lasted between six and eight hours compared to subjects taking a vehicle control. When data from the three studies were aggregated, the treatment showed a statistically significant overall treatment effect, reducing cramp intensity by three-fold compared to subjects taking a vehicle control (ANOVA, p<0.0001).
About Flex Pharma
Flex Pharma, Inc. is a biotechnology company that is developing innovative and proprietary treatments for exercise-associated muscle cramps, nocturnal leg cramps, and spasms associated with severe neuromuscular conditions. In three randomized, blinded, placebo-controlled, cross-over studies, Flex Pharma's proprietary treatment has shown a statistically significant reduction in the intensity of muscle cramps in healthy normal volunteers.
Flex Pharma was founded by National Academy of Sciences 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 Chairman and Chief Executive Officer Christoph Westphal, M.D., Ph.D.
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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: the success and timing of ongoing and anticipated clinical studies for our current product candidates; and the timing of and our expectations for the launch of our consumer product. Various factors may cause differences between our expectations and actual results as discussed in greater detail under the heading “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2014 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.
Flex Pharma, Inc.
Elizabeth Woo, 617-874-1829
SVP, Investor Relations & Corporate Communications