Flex Pharma (FLKS) Commences FLX-787 Phase 2 in AML

September 13, 2016 7:31 AM EDT

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Flex Pharma, Inc. (NASDAQ: FLKS) 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.”

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