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AAN Selects Flex Pharma Data for Oral Platform Presentation

Company to Present Human Proof-of-Concept for Treating and Preventing Muscle Cramps

BOSTON--(BUSINESS WIRE)--Feb. 18, 2015-- (Click to Tweet this News) Flex Pharma, Inc. (NASDAQ: FLKS), a biotechnology company that is developing innovative and proprietary treatments for nocturnal leg cramps and spasms associated with severe neuromuscular conditions, today announced that the Company’s data have been selected for an oral platform presentation at the American Academy of Neurology (AAN) 67th Annual Meeting being held in Washington, D.C. The abstract, titled “Orally-administered TRPV1 and TRPA1 activators inhibit electrically-induced muscle cramps in normal healthy volunteers,will be presented on Tuesday, April 21, 2015, from 3:45 to 4:00 p.m.

“These results support our belief that this treatment has significant potential as a solution for people suffering from sports-related muscle cramping, nocturnal leg cramps, as well as muscle cramping and spasms resulting from a broad range of neuromuscular disorders, such as multiple sclerosis, spinal spasticity and cervical dystonia,” said Co-Author Rod MacKinnon, M.D., Nobel Laureate and Co-Founder of Flex Pharma. “Muscle cramps can impact many types of individuals - even the fittest of athletes - at critical times.”

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 stop 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.

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).

"Nocturnal leg cramps can cause distress, interrupted sleep, reduced quality of life and interference with activities of daily living,” said Dr. MacKinnon. “We estimate that approximately four million U.S. adults over the age of 65 suffer daily from nocturnal leg cramps, a condition for which there is significant need since there are no approved treatments. In the second quarter of 2015, Flex Pharma intends to initiate a human proof-of-concept study of its proprietary treatment for individuals with nocturnal leg cramps.”

About Flex Pharma

Flex Pharma, Inc. is a biotechnology company that is developing innovative and proprietary treatments for 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 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 Chairman and Chief Executive Officer 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: the success and timing of ongoing and anticipated clinical studies for our current product candidates; our expectations regarding the effectiveness and safety of our 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 the registration statement on Form S-1 (commission file number 333-201276), which was declared effective by the Securities and Exchange Commission (SEC) on January 28, 2015. 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.

Source: Flex Pharma, Inc.

Flex Pharma, Inc.
Elizabeth Woo, 617-874-1829
VP, Investor Relations & Corporate Communications
irdept@flex-pharma.com