BOSTON--(BUSINESS WIRE)--
Flex Pharma, Inc. (NASDAQ: FLKS) today announced that it has initiated a Phase 2 efficacy study in amyotrophic lateral sclerosis (ALS) patients in Australia with FLX-787, its chemically synthesized, single molecule, transient receptor potential (TRP) ion channel activator, formulated as an oral tablet. The randomized, controlled, blinded, cross-over study is designed to evaluate the safety and efficacy of FLX-787 in patients who suffer from cramps and/or spasticity as a consequence of ALS.
ALS is a neurological disease that causes muscle weakness and impacts physical function. ALS often begins with muscle twitching and weakness in an arm or leg, or sometimes with slurring of speech. Eventually, ALS can affect the ability to control the muscles needed to move, speak, eat and breathe. ALS patients commonly experience fasciculations, which are persistent muscle twitches that can interfere with sleep, and over half of all patients with ALS also experience painful muscle cramps that can significantly decrease their quality of life. Based on a report published by the Centers for Disease Control, we estimate that over 12,000 people in the United States suffer from ALS.
“We have initiated three human efficacy studies this year – in nocturnal leg cramps, multiple sclerosis and now ALS – with our single agent candidate, FLX-787,” said Flex Pharma Chief Medical Officer Thomas Wessel, M.D., Ph.D., who served as the medical lead for three products approved in United States: Razadyne®, Lunesta® and Ampyra®. “We are hopeful that our efforts will ultimately help the many patients with severe neuromuscular diseases who suffer from these painful conditions.”
“Topical Chemical Neuro Stimulation is a process whereby small molecules activate TRP ion channels on sensory nerves in the oral mucosa, which we hypothesize signal through neural circuits to inhibit the hyperexcitable motor neurons in the spinal cord that can cause muscle cramps,” noted Dr. Rod MacKinnon, Nobel laureate and Flex Pharma Scientific Co-Founder, Board Member, and Scientific Advisory Board Co-Chair. “We hypothesize that this approach may be generally applicable as a treatment for cramps and spasms in a spectrum of neuromuscular conditions.”
About Flex Pharma
Flex Pharma, Inc. is a biotechnology company that is developing innovative and proprietary treatments for nocturnal leg cramps, cramps and spasms associated with severe neuromuscular conditions such as ALS and MS, and exercise-associated muscle cramps. 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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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 future studies of our current 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 of our clinical studies; the uncertainties inherent in conducting clinical studies, including receiving regulatory approval 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, 2015 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.
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