BOSTON--(BUSINESS WIRE)--Flex Pharma, Inc. (NASDAQ: FLKS):
Flex Pharma, Inc. (NASDAQ: FLKS), a biotechnology company developing innovative and proprietary treatments for exercise-associated muscle cramps, nocturnal leg cramps, and spasms associated with severe neuromuscular conditions, announced today at its Investor Day in New York City that the Company has selected FLX-787 as its clinical candidate for studies outside the United States. FLX-787 is a purified, GMP-synthesized single agent consisting of one highly selective and specific transient receptor potential (TRP) ion channel agonist.
“After testing the most potent TRPA1 and TRPV1 agonists and demonstrating enhanced efficacy with single molecules, as well as combinations of two individual molecules, compared to the original proprietary extract formulation, we have selected single agent FLX-787 as our clinical candidate to move forward into our future studies conducted outside the U.S.,” said Dr. Tom Wessel, neurologist and Flex Pharma Chief Medical Officer, who served as the medical lead for three products approved in United States: Razadyne®, Lunesta® and Ampyra®. “This selection represents an important step forward in our clinical efforts as it allows us to plan our future studies in MS, ALS, and nocturnal leg cramps (NLC) with this single agent. Subject to regulatory approval, we expect to initiate these studies in 2016.”
“We are excited to be on the forefront of investigating Chemical Neuro Stimulation as a novel and perhaps generally applicable method to treat disorders of cramping and spasms stemming from alpha motor neuron hyperexcitability,” commented Nobel laureate and Flex Pharma Scientific Co-Founder and Scientific Advisory Board Co-Chair, Dr. Rod MacKinnon. “Our mission at Flex Pharma is to define the positive impact of this novel insight to help people who suffer from cramps and spasms in several important settings.”
In addition to developing solutions for cramps and spasms associated with severe neuromuscular conditions, Flex Pharma is developing a consumer product for athletes to address exercise-associated muscle cramps.
“In limited markets next spring, we expect to introduce the first consumer beverage to prevent and treat muscle cramps that has the potential to be the foundation for a new category of sports nutrition: Neuro Muscular Performance,” noted Marina Hahn, President of the Consumer Division. “Developed with rigorous scientific methods, our proprietary formula of natural extracts in liquid form can address an issue that has vexed endurance athletes for years.”
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.
Individuals can follow the Company on Twitter (@flexpharma) and the Company's website (http://ir.flex-pharma.com/) to see the latest progress of the Company's pre-launch activities for its consumer product to prevent and treat exercise-associated muscle cramps.
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. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: our expectations regarding potential drug and consumer product candidates, the design and timing of ongoing and anticipated clinical studies and our drug development progress and the launch of our consumer product. 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 interpretation of our clinical studies; the uncertainties inherent in conducting clinical studies; results from our 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 the 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, 2014 and subsequent filings with the Securities and Exchange Commission (SEC). You are encouraged to read our 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.
