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Flex Pharma Completes Enrollment of Human Proof-of Concept Efficacy Study in Nocturnal Leg CrampsFlex Pharma, Inc. (NASDAQ: FLKS) today announced that it has completed enrollment of its human proof-of-concept efficacy study in nocturnal leg cramps (NLC) with its chemically synthesized, single molecule, transient receptor potential (TRP) ion channel activator, formulated as an orally disintegrating tablet. Subject enrollment for this study initiated in late May and completed ahead of plan. This randomized, blinded, controlled, cross-over study is designed to evaluate the safety and efficacy of its single agent in over 50 subjects who suffer from frequent nocturnal leg cramps. Topline results are expected by year end. Nocturnal leg cramps can cause severe pain, interrupted sleep, reduced quality of life and can interfere with activities of daily living. The Company estimates that NLC affects over four million Americans nightly. There is no approved therapeutic in the United States to treat this condition. "The rapid enrollment into this study underscores the substantial unmet need for a therapeutic agent for people who suffer from frequent leg cramps at night," 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®. "Given the underlying mechanism of alpha motor neuron hyperexcitablity in cramps and spasms, we have also initiated a Phase 2 study with our single agent for patients with MS, and we expect to begin our Phase 2 study in ALS patients later this year." These studies in MS and ALS will be conducted outside the U.S. "Flex Pharma's agent is the leading clinical candidate for NLC and I am hopeful that their efforts will ultimately help the millions of people who suffer from this painful condition and currently have no safe and effective therapeutic options," noted John Winkelman, M.D., Ph.D., Chief of the Sleep Disorders Clinical Research Program at Massachusetts General Hospital and Flex Pharma Scientific Advisory Board member, who was involved in te clinical development of both Requip® and Mirapex®, approved agents for restless legs syndrome (RLS). The current study builds upon a completed, successful, randomized, controlled, blinded cross-over study (n=50), in which the Company's extract formulation demonstrated statistically significant positive human efficacy on the key endpoints. Results from that study were accepted and presented as a late-breaker at the American Academy of Neurology Annual Meeting in April 2016. 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 MS and ALS, and exercise-associated muscle cramps. Flex Pharma was founded by National Academy of Science members Rod MacKinnon, M.D. (2003 Nobel (News - Alert) 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. Visit www.TeamHOTSHOT.com for updates and to learn more about HOTSHOT™, the Company's consumer product which is scientifically proven to prevent and treat muscle cramps. HOTSHOT is a consumer product that is marketed to endurance athletes for exercise-associated muscle cramps. HOTSHOT complements the Company's drug development business and is not intended to diagnose, treat, cure or prevent any disease. Follow Flex Pharma (@flexpharma) and HOTSHOTTM( @Team_HOTSHOT) on Twitter (News - Alert)
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