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Press Release

FDA Clears Flex Pharma's FLX-787 to Commence US Phase 2 Trial in ALS Under IND

BOSTON--(BUSINESS WIRE)--Apr. 26, 2017-- Click to Tweet this News

Flex Pharma, Inc. (NASDAQ: FLKS), focused on developing treatments for cramps and spasms associated with the severe neurological diseases of amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS) and peripheral neuropathies such as Charcot-Marie-Tooth (CMT), today announced that the Company's investigational new drug (IND) application for FLX-787 for patients with ALS is effective which allows the Company to commence its U.S. Phase 2 clinical trial of FLX-787 in ALS patients who suffer from cramps as a consequence of the disease. The Company expects to begin enrolling US patients this summer in this randomized, controlled, double-blinded, parallel design study, referred to as the COMMEND trial. In addition, the Company has exploratory Phase 2 studies currently ongoing in patients with MS and ALS in Australia. FLX-787 is a small molecule co-activator of the TRPA1 and TRPV1 ion channels, and has been shown to prevent and reduce the frequency and intensity of muscle cramps in a human model of electrically induced cramps.

“This open IND for FLX-787 allows us to initiate this Phase 2 multi-center trial, representing an important milestone for Flex Pharma and starts the process of investigating other orphan indications in neurology where cramps, spasms and spasticity impact patients every day,” said Flex Pharma Chief Medical Officer Thomas Wessel, M.D., Ph.D. “Based upon encouraging results in prior randomized, controlled studies of FLX-787 in models of muscle cramping in healthy volunteers, we are excited to advance FLX-787 into this Phase 2 clinical trial for ALS this summer.”

“Muscle cramps can have a severe impact on functional performance and quality of life for patients with motor neuron diseases like ALS,” indicated lead investigator Dr. Björn Oskarsson of the Mayo Clinic in Jacksonville, Florida. “Neurologists are often confronted with a situation where the patient experiences symptoms, and current treatments are either ineffective or have limiting potential side effects. Flex Pharma’s FLX-787 may provide a better approach to this challenging problem.”

“Very shortly, we also plan to submit a protocol to the IND for a clinical trial of FLX-787 to treat patients with CMT, which would enable us to begin another Phase 2 this summer, making FLX-787 one of the most advanced novel compounds in development for CMT,” said Flex Pharma R&D President Bill McVicar, Ph.D. “Together with our ongoing exploratory Phase 2 studies in MS and ALS in Australia, we are focused on the execution of these studies and expect to have several data readouts in 2018.”

COMMEND Trial Design

This Phase 2 clinical trial is designed to evaluate FLX-787 in patients with motor neuron disease (MND), focused on ALS, who suffer from cramps. This randomized, controlled, double-blinded, parallel design trial in the US will include a run-in period to establish a baseline in cramp frequency. Patients will then be randomized to 30 mg of FLX-787 administered three times a day or control, for 28 days. Patients will be evaluated for changes in cramp frequency as the primary endpoint, with a number of secondary endpoints.

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 clinical trials 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 trials; the fact that we rely on third parties to manufacture and conduct the clinical trials, 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.

Source: Flex Pharma, Inc.

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