Thinly traded micro cap Flex Pharma (FLKS +31.4%) flexed some muscle today on more than double normal volume, albeit on turnover of only ~215K shares, in response to its announcement that its recently completed study in nocturnal leg cramps (NLCs) has been selected for presentations at the American Academy of Neurology 68th Annual Meeting in Vancouver, B.C. The results will be presented on Tuesday, April 9.
The study assessed the company's proprietary extract formulation, to be sold as a dietary supplement, in reducing NLCs. The results showed a statistically valid treatment benefit on several key endpoints, including muscle cramp frequency, sleep disturbance measures and pain metrics.
According to the company, its treatment stimulates the primary sensory neurons in the mouth, stomach and esophagus by activating transient receptor potential (TRP) cation channel receptors. In other words, the small molecule compound, acting topically, generates an electrical signal for therapeutic effect. TRP activators are recognized as safe by the FDA when used in food products so Flex does not expect to file an IND with the FDA.
It plans to initiate another NLC study assessing a single molecule TRP agonist later this year. Also on tap for this year ex-U.S. are studies evaluating drug candidate FLX-787 in multiple sclerosis and amyotrophic lateral sclerosis.
Previously: Flex Pharma completes enrollment in nocturnal leg cramp study (Jan. 6)
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